Legal Rights of Parents for Cord Blood Collection

There was once a time, when we had just initiated StemLife, that I was personally visiting obstetricians to let them know about our service. It was feet-killing work for the initial years, long hours in formal attire and smart shoes, sitting in many a doctor's waiting room for hours before the patients would clear out and the obstetricians could spare a few precious moments to hear us out.

Inevitably, one of the questions that would come up among the more astute clinicians would be regarding the legal implications of collecting umbilical cord blood (perhaps they have experienced litigious clientele themselves before). They would ask what the implications are should the collection not be successful or if there was an emergency and the cord blood could not be collected due to some unpredicted situation. StemLife has a very specific form and clause for this, nothing is absolutely guaranteed and we explain very carefully to parents that in the event of an emergency, the life of mum and babe comes first.

In the same vein, I thought that this article was interesting in that Professor Colin McGuckin has brought up another scenario in which parents would have possible legal recourse with doctors.

That cord blood stem cells have been harnessed for regenerative medical purposes cannot be denied. From trials being conducted on Type 1 diabetes in Florida to Cerebral Palsy at Duke, parents of these afflicted children were not able to foresee the fate of their child nor to take any measured steps to prevent the problem from happening. Doctors also have no way of guaranteeing the safety and wellness of mother and baby. Although advanced equipment and well trained staff can help in mitigating risk factors, everyone appreciates that there are no absolutes in life.

Parents world over who have healthy children, born without any genetic condition and fault may or may not appreciate what parents who have a lifetime of sleepness nights ahead go through without a shred of hope or any help from clinicians who refer to text books and tell parents that there is no cure.


I do appreciate that not every parent can or will want to bank their cord blood stem cells for a variety of reasons but it would seem to me that it would be a good idea for clinicians to cover themselves by at least letting the patients know that the service exists and a stamp on their folders to indicate that they've been told so as to pre-empt that unforseeable case in the future.

Autologous-OWN-Stem Cell Infusion And Hyperbaric Oxygen Treatment Improve Islet Function In Diabetes

A study to determine if patients with type 2 diabetes can benefit from a combination of autologous (patient OWN self-donated) stem cell infusions (ASC) and hyperbaric (above the normal air pressure of ) oxygen treatment (HBO) before and after ASC has found "significant benefits" in terms of "improvements in glycemic control" along with "reduced insulin requirements."

The combination therapy could decrease type 2 diabetes morbidity and mortality, said the authors, who published their study results in a recent issue of Cell Transplantation (Vol. 17 No.12).

"Autologous stem cell therapies are an emerging set of therapies with promising results and low side effects profiles," said corresponding co-author Esteban Estrada, MD, of Stem Cell Argentina.

"In addition, hyperbaric oxygen therapy, used primarily in the treatment of carbon monoxide poisoning, air embolism suffered by divers, and as an enhancement to wound healing, has been shown to increase stem cell mobilization and the release of endothelial progenitor cells via a nitric oxide-dependent mechanism."

The clinical trial evaluated the safety of ASC-HBO combination treatment in 25 patients with type 2 diabetes.

According to the researchers, it is well known that with type 2 diabetes, there is an ongoing inflammation of the pancreas. Their hypothesis suggested that mobilizing stem cells would cause the growth of blood vessels (angiogenesis) and release factors that would result in the local differentiation of progenitor cells with a resulting anti-inflammatory effect. Diabetes, they added, has been shown to impair progenitor cell mobilization, a problem that local stem cell infusion could remedy.

Once more, the effect of the hyperbaric oxygen therapy, they hypothesized, would be to increase stem cell mobilization in such a way as "to target more than one crucial reparative step" to counteract the chronic injury that attack the endothelial progenitor cells and the islet cells.

"Overall, our results show that a close follow-up with intensive diabetic management alone could not be the only cause of the positive, progressive and consistent outcomes we obtained in this trial over one year of follow-up," said Dr. Estrada.

"A decade ago, research had explored stem cell transplantation and hyperbaric oxygen therapy as stand alone treatments. This study highlights the potential benefits of using an unusual combination therapy to treat diabetes" said Dr. Cesar V Borlongan, Associate Editor of Cell Transplantation and Professor at the University of South Florida College of Medicine.


References

Estrada, Esteban J.; Valacchi, Fabian; Nicora, Eduardo; Brieva, Sergio; Esteve, Claudio; Echevarria, Laura; Froud, Tatiana; Bernetti, Karina; Cayetano, Shari Messinger; Velazquez, Omaida; Alejandro, Rodolfo; Ricordi, Camillo. Combined Treatment of Intrapancreatic Autologous Bone Marrow Stem Cells and Hyperbaric Oxygen in Type 2 Diabetes Mellitus. Cell Transplantation 2008; 17 (12): 1295-1304.

Cord Blood Banking in the Middle East

If there's one building that I never get tired of looking at in KL, it has definitely got to be the Petronas Twin Towers. If the number of tourists in the park just beneath it is any indication, it confirms that I am certainly not the only one. Since the sunshine brings such perfect days and stormy nights, even the movie producers are out in full force, taking full advantage of the predictability of cloudless skies.

These towers were once the tallest in the world (est 1998), but it has now been beaten by the Taipei 101 (2004) and I read that the completion of Dubai's Burj Dubai which is a huge structural icon in the making, will rank number one as of next year if the project finishes on schedule (estimated completion Dec 2009).

I know you must be wondering where I'm going with this but please indulge me a little longer.

As someone who has yet to visit the middle east nations, I can only imagine what their cities and populations are like. Dubai has a population of just over a million people, so I'm wondering what all the space in the Burj will be used for, but I suppose that they are planning to attract migrants to the city and plan to expand the city's population to three times of what it is today in the next one or two decades.

The population in other Arab Emirates is also fairly small. Doha, the capital of Qatar which lies westerly of Dubai across the sparkling Persian Gulf competes with Dubai in terms of infrastructure and is likewise in the process of establishing itself for other activities apart from finance. Doha laid claim to a fantastic sports center built to groom and train athletes for modern Olympics and apparently also has some architecturally tasteful and stylish designer buildings which serve as office and varsities.

Qatar is wealthy due to their oil and gas deposits which provide the financial bedrock for the economy and with a small population of less than a million, the GDP is thus very high.

It is in Doha which Richard Branson and his partner Excalibur (PE fund) have decided to relocate and re-launch the Virgin Cord Blood Bank with the new name of Virgin Health Bank QSTP (where QSTP is an abbreviation for Qatar Science and Technology Park).


WHY DOHA?

According to the press article, the Virgin Team did consider other major cities in the UAE but decided on Doha due to the Qatari commitment from the government and its Queen:

BACKED BY THE GOVERNMENT
"Branson said today that the bank chose Qatar because “the government of Qatar and the queen in particular understood the importance of this and wanted it.” Evans said that the presence of facilities such as the Weill Cornell Medical College campus and the future Sidra Medical & Research Center (now under construction) in Qatar were also part of the country’s draw."

The Qatar Science Center (featured on the right)


HOW MUCH?

At the press conference held on Tuesday, the investment in starting a cord blood bank was announced to require 9 million British Pounds (46 million RM) while stating that 10 million USD had already been spent.

As for the charge for Virgin's services which encompass a private-public model, nothing is confirmed but it is supposed that the Qatari government will initiate the project by footing the bill. Given a birth rate of approx. 16 births per 1000 people, all of Qatar would have a birth rate of 16,000 per year. Not too much to handle if most deliveries are managed by a few hospitals.

The shareholders have declared that all profits from the service will be channeled back into health care charities, and to be fair to the corporates, probably less operational and running costs.


NEW GOALS

"The company’s goal is to create a comprehensive source of stem cells that could be of particular use for treating people of Middle Eastern descent, whose tissue types are often underrepresented in the public tissue banks such as those in the U.S. and elsewhere. “This cord blood bank could end up being bigger than the U.K.’s bank quite quickly,” Branson noted at a press conference today marking the company’s inaugural board meeting in Qatar."

I wrote about Virgin's plan previously and if you need a helpful reminder of what it was, click here.


Cultural Mind-Shift

One of the acknowledged challenges of the service would be to convince the Qataris to participate and engage the cord blood service. I was very impressed to know that the Qatari Islamic religious leaders are forward thinking and have already issued a fatwa (muslim sharia law) approving the collection of cord blood and encouraging its use. Dr. Yousuf Qaradawi a prominent Islamic scholar has endorsed its use.

Here in Malaysia, it would be great if the Islamic leaders would take up the issue and do the same in responding to the concept of cord blood banking.

We're being SPAMMED by StemTech

I'm not sure how we've managed to make it onto StemTech's spambot list of blogsites, but we've just been patiently deleting them as they come in.

Today, I changed my mind and instead of just going ahead to hit delete, I've decided to dedicate an entire post entry to them due to the fact that they have been actively making their rounds in Malaysia.

One bottle of algae based supplements sells for RM 200+ per bottle (I'm told by those who have bought it) and is supposed to raise your own body's endogenous stem cells by an amount significant enough to increase one's sense of well-being.

My colleague Prof. Aw - who by the way is a recent convert to supplementation- was contacted by one of the StemTech agents/ distributors before. He asked them to send him journal papers (which they claimed they had) and on a second encounter, asked them to do a proof of concept trial by checking on the amount of stem cells raised after taking the supplements for a month.

NO REPLY was forthcoming.

I was even more surprised when I discovered that the french neurologist scientist who is the founder of the organization was invited to present at one of the major hospital's inaugural lecture series here. Due to the heavy downpour, none of us were able to attend but we were most curious as to whether they had received some sort of approval from our government, or whether the major hospital chain was endorsing their product.

I've asked some of the people who are taking this supplement to subject themselves to a simple trial which we'll conduct to see if what they've claimed is true. If I'm able to convince them, I'll be sharing the results with you.

If you're from StemTech and you're reading this, you might like to sponsor the trial if the confidence you have in your product is high.

If not, please stop misleading the public and don't use the term stem cells - call it what it probably is- a vitamin supplement.

===

Stem Cell Enhancers: The NEW Science

Standing singly, away from all the controversy, some of the scientific community is giving rise to the world's very first patented, organic stem cell enhancer. With only a single dose of this modern day amazement your body can begin the renewal process. In fact, within just one hour after taking this wonder supplement,three to 4 million, yes MILLION stem cells are added to your bloodstream and go to work.

StemEnhance is a revolutionary breakthrough, all natural product that supports adult stem cell physiology. It's the first patented product on the market in the latest phytoceutical category called "Stem Cell Enhancers".http://www.phyl247.com or http://www.phyl247.biz phyl247 970-985-4076
As we age, the number and quality of stem cells that circulate in our body gradually decrease, leaving our body more susceptible to injury and other age-related health challenges. StemTech Health Science's Stem Enhance is the alternative to the controversial stem cells we hear about in the news. Patented Product StemEnhance supports the natural release of stem cells to promote optimal healing and stem cell physiology.

=============

Note to StemTech: Please stop spamming us.

Singapore advertises Cord Blood Stem Cell Banking (Part 2)

A Cordlife ad was timed right after the appearance of the Singapore Cord Blood Bank's news article - and that wasn't a coincidence.



In fact this latest ad was a masterful stroke of PR execution, citing rates of stem cell usage from the SCBB's own article and adding on the other applications worldwide. It highlights what families ought to store their own babies stem cells for their own use and advocates that private cord blood banking ensures 100% accessibility to your own banked cells.


If you can't see the facts and figures in the picture above here's the wording on the left:

Incidence rate of stem cell treatable diseases:

6 people are diagnosed with blood related diseases in Singapore every day
2 of the top 10 cancers afflicting Singaporeans are Lymphoma and Leukemia
1 in 500 babies are diagnosed with Cerebral Palsy
2 children are diagnosed with Type 1 diabetes in Singapore every month
80 diseases are now treatable using cord blood stem cells and possibly more in the future.

Chances of using stem cells:

1 in 217 chance that a person may need cord blood stem cells for treatment in their lifetime
80 cord blood units were released for transplants and therapeutic applications by Cordlife.

Higher chance of finding a match within the patient's family:

70% of cord blood transplants by Cord Blood Registry were from siblings. 30% was for self use.
75% chance of a sibling match
25% chance of a 100% match between siblings. A perfect match is required for bone marrow transplants but not in cord blood transplants.
$26,000 is the minimum cost of buying back a donated cord blood unit if it is still in storage.

Availability of stem cells:
50% of all donations to a public cord blood bank are normally discarded for various reasons
100% - your accessibility to your privately stored cord blood stem cells.



All true of course, and I've always wondered this: Singapore's birth rate is at thirty to forty thousand per year and it's conceivable that there may be a time when every Singaporean has his or her cord blood stem cells banked in the future. Given Singapore's small population, its probably the best place imagining that this could happen, a very accessible and heterogenous database which could be leveraged for treatment and if consented, research for autologous regenerative purposes.


Now that would be really cool.


** Unfortunately the online version of this article isn't the full version that was published in print.


Malaysian Medical Advertising Regulations prohibits any form of advertising using terms ranging from "treatment" to "Thalassemia" so it is virtually impossible for us to advertise as our neighbors did (all brochures and the stem cell organization are required to be separately licensed by the Ministry of Health, so make sure the stem cell bank you're talking to has all the documented approvals and are operating within legal guidelines).

However, since all of it was factual and cited from peer-reviewed journals and both local and international news articles, its good to share these statistics with our patient base here too.


More information on StemLife's stem cell banking services can be found at www.StemLife.com

===

Singapore Advertises Cord Blood Stem Cell Banking (Part 1)

Last week in the Singapore Straits Times, there were two snippets about cord blood stem cell banking. The first one was a news piece on the Singapore public cord blood bank (entitled Cord Blood Bank has saved 21 lives**) which was campaigning for an increase in units (arguably an ad in itself). The other snippet was an ad by a local private Singapore Cord Blood Bank Cordlife. The ad appeared 2 days after the news article and I don't think its a coincidence to keep the conversation and interest in Singaporean's minds.

The first article from the Singapore Cord Blood Bank at a press conference reveals quite a lot about what its like to be an operator of a public bank:

How many cord blood stem cell units have been released and where have they gone?

"In the 3 years it has been open, the Singapore Cord Blood Bank has saved 21 lives - here and overseas... a 22nd donation was winging its way over to France"

"Of the 21 recipients, 12 were patients here while the other nine were ethnic Asians in Europe and Malaysia."

Comment: 21 cord blood units utilized in transplantation is very respectable for a small bank. Financially, at a purchase price of SGD 26,000 per unit in Singapore, the SCBB would have generated SGD 312,000 in revenue for the 12 Singaporean patients and another approximately SGD 320,000 from the 9 overseas patients (assumption is that these patients came through the NMDP network and paid the standard price). That would bring the SCBB's total revenue to SGD 632,000 or slightly more than this.


How many Singaporeans have donated cord blood and how many of those have been successfully banked?

"The repository has been able to bank about half of the 9,000 donations so far. Donations sometimes do not yield enough stem cells to be viable*."

Comment: The yield of 50% is very much in line with what I've heard from other public cord blood banks. However the article doesn't explain that units are discarded due to bacterial / viral contamination (let's not forget that vaginal flora and fauna can be quite substantial) and that the cord blood bank sets its own guidelines as to the volume and/ or cell count required at the beginning before they proceed to process the unit.

As a guide, at the time of receipt of the cord blood unit, most public cord blood banks insist on a minimum volume of 100 mls or total cell counts exceeding 1 billion. The rationale for this is that the cord blood unit needs to be at a level high enough to treat an adult (including caucasian weight & bigger sized asians), otherwise its not worth keeping (bearing in mind that this inventory can and most certainly will take years to clear). *Thus the term "viable" in the article refers to the unit's chances of being used.

Targets for the Singapore Cord Blood Bank?

"An earlier target of banking 10,000 samples by next year has been extended to 2013 said Mr. Sobak (SCBB's CEO and COO of SingHealth), since its been harder to get good-quality donations."

Comment: 10,000 units in the tank is an ambitious target but let's consider the following points:

1) The SCBB is based in the KK Women's and Children's Hospital, which alone delivers the vast majority of Singaporean babies has handled almost 40,000 babies at its peak, but more likely in the range of fifteen to twenty thousand now.

If the SCBB were able to collect all of the cord blood units from all the babies delivered there per year, without approaching any other hospitals (and discounting the 50%) the SCBB would have had about twenty thousand or so units by now. But, that would mean that they would have been working at a pace of 20 units per day seven days a week, all year round for 3 years. Hence the limitation of time, processing space and cost all plays a part in the operational capacity. [4 years more for 5000 units]

2) Cordlife, the first local Singaporean private cord blood bank started in 2001 only recently achieved 13,000 units in 2008 (announced in an ad) and claim only a 1% contamination rate, which means that they store almost every unit they receive. So repositories take a long time to build. [7 years for 13,000 units]

3) StemLife achieved 10,000 units in 2006, about 4 years after operational commencement (I assure you, not without toil).


Another target mentioned by the CEO was 30 transplants for the financial year 2009. I find this to be an interesting target, as I suspect it greatly depend on whether the requests just happen to match the units in the tank? Or perhaps it is now possible to analyze the recipient population and to try to identify the relevant donors to collect the cord blood from.

Anyway, getting back to the financial year for SCBB, I suppose the financial target would be in excess of SGD 1 million in revenue - if they manage to sell the inventory overseas. It is a business after all.


What are the likelihoods of use?

"At least six people are diagnosed daily in Singapore with different types of blood-related diseases said the bank's medical director William Hwang."

"Many of these patients will require a blood stem cell transplant to survive"

"With these samples and those fom banks worldwide, the odds of local patients finding a match is about 10-20%"


OK, quick back of the envelope calculation here. 6 people diagnosed daily in Singapore with a blood related disorder, ie 2000+ people. Let's say 50% will require a transplant at some stage, so let's bring the figure to about 1000 people needing a transplant.

And since only 10-20% will be able to find a match from all available units locally and internationally, ie 100-200 people will get their stem cell treatment... and the rest will have to wait.

Sel Stem dan Statistik Transplantasi Darah Tali Pusat

Bolehkah Sel Stem Darah Tali Pusat Bayi Merawat Penyakit Thalassaemia Kakak/Abang?

Apakah Statistik Kegunaan Sel Stem Darah Tali Pusat?

Asalamualaikum,

Salam dan semoga Sihat Sejahtera.

Baru-baru ini Saya telah mendapat beberapa soalan mengenai kegunaan sel stem darah tali pusat bayi.

Untuk soalan pertama, pembaca perlu menjawab beberapa soalan. Adakah pesakit sedang berulang ke hospital untuk dirawat oleh pakar Thalassaemia? Jika tidak, mungkin keadaan mereka, setakat ini, belum memerlukan rawatan. Jika ya, pembaca perlu tekun menyoal dan menyaran pakar Thalassaemia supaya meneliti samada keadaan pesakit sudah menurun dan perlu dirawat dengan kaedah lain seperti sel stem?

Sel stem boleh didapati dari sum-sum tulang, tetapi tekniknya agak invasif. Cara yang lebih senang untuk mendapatkanya ialah dari darah tali pusat yang diambil semasa bayi dilahirkan. Kedua-dua sumber ini ada bezanya dari segi kematangan sel, kaedah penggunaan, risiko dan keberkesananya.

Sel stem darah tali pusat bayi, jika disimpan semasa bayi dilahirkan, memang besar potensinya untuk diggunakan. Tetapi, ada beberapa syarat yang perlu dipatuhi. Darah tali pusat mestilah mengandungi jumlah sel stem yang mencukupi, padanan HLA yang tinggi dan tidak berpenyakit.

Sel Stem dari bayi perlu sepadan (secara ujian darah HLA) dengan sel kakak atau abangnya. Jika separa sepadan atau sepadan sepenuhnya, memang ada potensi ianya digunakan untuk menolong merawat kakak atau abang. Sel stem juga perlu bebas dari Thalassaemia dan penyakit lain. Pakar Thalassaemia perlu memutuskan samada keadaan pesakit sudah kritikal dan memerlukan rawatan sel stem.

Proses pengambilan darah tali pusat perlu dilakukan semasa bayi dilahirkan. Sejurus selepas bayi dilahirkan, dan sebelum uri dilahirkan. Doktor di Hospital akan mengambil darah dari tali pusat. Prosesnya senang, seperti proses derma darah biasa. Ianya cepat dan tidak melukakan bayi atau ibu. Kami tidak mengambil tali pusat atau pun uri. Penggunaan sel stem darah tali pusat dalam perubatan boleh dilakukan tanpa keraguan kerana pihak JAKIM telah pun mengeluarkan Fatwa pada tahun 2002.

Kami akan membekukan dan menyimpan sel stem darah tali pusat ini untuk kegunaan bayi sendiri atau mungkin untuk kegunaan kakak atau abangnya dimasa hadapan.

Apabila Pakar Thalassaemia berpendapat rawatan susulan kakak/Abang memang diperlukan, dan sel stem dijangka boleh memberi kesan, pakar-pakar akan meminta supaya sel stem darah tali pusat yang disimpan dibawa ke hospital untuk digunakan.

Pesakit Thalassaemia juga mungkin boleh mendapatkan sel stem darah tali pusat dari pihak Bank Darah Kerajaan di Pusat Darah Negara, KL, http://www.pdn.moh.gov.my/.

Senangkah untuk mendapatkan sel stem ini?

Saya belum pernah melihat statistik di Malaysia yang boleh menolong untuk membuat anggaran tepat. Sel stem yang disimpan di PDN telah didermakan. Agak sukar untuk membuat anggaran samada sel stem, yang sepadan dengan pesakit, boleh didapati dengan senang di Bank Darah Kerajaan atau pun tidak.

Saya pernah membaca di akhbar New Straits Times, 14 Ogos 2006, yang melaporkan pada masa itu, terdapat 17 kanak-kanak yang memerlukan transplantasi sel stem tetapi terpaksa menunggu untuk mendapatkan sel stem dengan padanan yang sesuai. Wartawan juga melaporkan bahawa ada yang tidak dapat menunggu dan tidak dapat diselamatkan walaupun Pusat Darah Negara telah menyimpan lebih kurang 1,000 beg sel stem darah tali pusat.

Jumlah itu, dari segi statistik, terlalu rendah untuk membekalkan darah tali pusat bagi pesakit yang memerlukanya. Ada beberapa anggaran yang sering disebut di laman web-laman web bank darah tali pusat. Anggaran untuk mendapatkan sel stem, bukan dari keluarga sendiri, yang sepadan dengan pesakit adalah dalam lingkungan 1 dalam 20,000. Dengan statistik kebarangkalian padanan yang amat rendah ini, peluang 17 kanak-kanak itu kelihatan agak tipis. Alternatif lain perlu di usahakan. Sebab itulah, kita sering dapat membaca dalam akhbar-akhbar tempatan pesakit-pesakit merayu untuk mendapatkan dermaan sel stem. Sebab itulah juga mengapa ramai pelanggan kami menyimpan sel stem sendiri bagi kegunaan keluarga sendiri.

Pembaca juga boleh layari laman web Persatuan Transplantasi Malaysia http://www.mst.org.my/, dimana terdapat Senarai Transplantasi Kebangsaan. Laporan itu menunjukkan setakat tahun 2006, 1174 pesakit telah menggunakkan sel stem dimana 50 telah menggunakkan samada sel stem darah tali pusat sahaja ataupun dengan tambahan sel stem yang didapati dari sum-sum tulang.

Setakat ini Syarikat StemLife Berhad telah menyimpan sel stem darah tali pusat untuk lebih dari 23,000 pelanggan. Empat (4) pelanggan kami telah berjaya menggunakan sel stem darah tali pusat mereka samada untuk abang, kakak atau adik mereka dalam menolong merawat penyakit Leukaemia dan Thalassaemia. Satu (1) telah dirawat di Hospital Kuala Lumpur dan tiga (3) di Pusat Perubatan Universiti Malaya.

Pembaca juga disyorkan untuk melayari laman web http://www.parentsguidecordblood.com/ dan http://www.apcbbc.org/ untuk mendapatkan statistik simpanan/kegunaan di seluruh dunia dan di rantau Asia Pasifik. Laman web yang kedua ada membentangkan jumlah simpanan ahli-ahli persatuan iaitu bank-bank sel stem darah tali pusat terkemuka di rantau Asia Pasifik yang pada masa ini dipengerusikan oleh Pengarah Urusan StemLife Berhad.

Saya harap telah dapat menjawab beberapa soalan anda. Jika jawapan yang lebih terperinci diperlukan, sila hantarkan nombor anda kepada info@stemlife.com dan kami boleh menghubungi anda untuk memberi maklumat yang lebih mendalam lagi.

Sekian buat masa ini......Wslm..WBK.......................

Bank Sel Stem sudah lama wujud dalam bidang perubatan!

Assalamualaikum WBK,

Salam Sejahtera kepada rakan-rakan saya sekelian, ibu-bapa, bakal ibu-bapa, pengunjung/pembaca blog ini.

Kebelakangan ini Menteri Kesihatan Malaysia Y.B. Dato’ Liow Tiong Lai telah melawat premis kami di Wisma Perintis untuk melihat sendiri operasi pengambilan sel stem dewasa StemLife serta untuk memahami dengan lebih mendalam lagi status penggunaan sel stem dewasa dalam bidang kepakaran penyakit jantung, barah darah, dan kecederaan sendi serta mendapat penjelasan mengenai projek-projek penyelidikan yang giat dijalankan di seluruh dunia.

Beliau telah menekankan komitmen Kerajaan dalam mengunakkan teknologi sel stem dalam bidang perubatan di Malaysia. Pada pendapat saya, ini adalah kerana fakta-fakta adalah jelas sekali tentang potensi sel stem dalam menolong pakar-pakar perubatan menangani beberapa penyakit yang setakat ini amat sukar ditangani. Ini sekaligus meningkatkan kebolehan pakar-pakar Negara supaya tidak ketinggalan zaman.

Seperti yang disiarkan akhbar-akhbar tempatan, Kerajaan menyokong bidang penyelidikan sel stem. Kabinet telah membuat peruntukkan lebih RM32juta untuk mengembangkan dan mengukuhkan aktiviti perbankan sel stem. RM5.86juta untuk memulakan makmal transplantasi sel stem di Institut Penyelidikan Perubatan (IMR). RM18.87juta untuk mengembangkan kemudahan simpanan sel stem darah tali pusat di Pusat Darah Negara dan di Hospital Sultan Abdul Halim, Sungai Petani. Kerajaan juga telah memperuntukan RM5.57juta untuk mengukuhkan perkhidmatan transplantasi sel stem dan sum-sum tulang di Hospital Ampang. Ini diharapkan akan meningkatkan jumlah simpanan beg sel stem darah tali pusat dan mengukuhkan tahap kemudahan perbankan kerajaan. Kami berharap pihak Kerajaan akan menyediakan peruntukan yang lebih dimasa akan datang supaya fasiliti dan kemudahan tempatan dapat bertanding diarena antarabangsa.

Ramai mungkin telah membaca akhbar-akhbar tempatan dan luar negara yang sering menerbitkan kes-kes rayuan pesakit untuk mencari penderma sel stem dan juga dermaan kewangan yang diperlukan dalam masa yang suntuk dan keadaan tertekan. Mengapakah ini boleh berlaku jika stok simpanan sel stem bank darah dalam dan luar negara mencukupi? Besar kemungkinan memang stoknya tidak mencukupi dan juga agak sukar bagi seorang pesakit untuk mendapatkan sel stem yang sepadan dengan sistem darah pesakit itu sendiri. Anggaran kebarangkalian mendapatkan penderma sel stem adalah satu (1) dalam dua puluh ribu (20,000) dan kebawah. Ini bermakna, jika saya memerlukan sel stem, terpaksalah saya mempelawa 20,000 rakan untuk diuji dan mungkin hanya 1 akan sepadan dan boleh menderma. Kemungkinan mendapatkan penderma bukanlah rendah sangat, tetapi, ia mungkin akan mengambil masa yang agak lama jika tiada simpanan sendiri. Ini seakan ”Sindrom Waiting List”.

Sepertimana kita boleh lihat dalam industri perubatan Malaysia, inisiatif swasta boleh dan perlu diusahakan seiring dengan inisiatif Kerajaan. Ini jelas dilihat dimana terdapat kewujudan Hospital Kerajaan dan Hospital Swasta, Doktor Kerajaan dan juga ramai lagi Doktor Swasta. Sudah terbukti di seluruh dunia kewujudan Bank Sel Stem Kerajaan/NGO boleh wujud seiring Bank Sel Stem Swasta malah beberapa bank Kerajaan/NGO dan Bank Swasta di UK telah berjaya berganding bahu untuk menawarkan perkhidmatan menyeluruh supaya warganegara dapat memilih perkhidmatan yang memenuhi kehendak mereka.

Bank Sel Stem darah tali pusat telah mula beroperasi di dunia mulai awal tahun ’90an. Bank-bank di Singapura, Taiwan, Korea, Jepun, Hong Kong sudah beroperasi lebih 10 tahun. Setakat ini terdapat anggaran 150 bank-bank darah tali pusat Kerajaan, NGO dan Swasta di dunia. Anda boleh layari laman web www.parentsguidecordblood.com untuk mendapatkan senarai bank-bank swasta dan Kerajaan/NGO. Negara-negara yang tidak membenarkan operasi bank sel stem swasta hanya segelintir sahaja. Kebanyakkan negara-negara besar di dunia seperti Amerika Syarikat, Kanada, UK, Perancis, Jerman, Australia, New Zealand dan kebanyakkan Negara Asia membenarkan malah menyediakan polisi, akta-akta, garispanduan dan piawaian supaya bank-bank in dapat berkembang serta menyumbang kepada Ekonomi Negara sambil meningkatkan tahap penyelidikan sel stem di negara masing-masing.

Dalam Tanahair pula, apa status nya? Bank sel stem StemLife telah beroperasi semenjak tahun 2001. Kami telah dijemput oleh ’Multimedia Development Coorporation’(MDC) untuk membuka makmal simpanan kami di Cyberjaya dan diberi status MSC. Makmal kami mula beroperasi di Cyberjaya di bangunan MDC iaitu ’Center for Health Innovation & Medical Enterprises’ (CHIME) yang dirasmikan oleh YB Tun Perdana Menteri pada tahun 2002. Bank sel stem Kerajaan di Pusat Darah Negara juga telah dibuka disekitar tahun-tahun yang berdekatan. Kali pertama Sel Stem dewasa/sum-sum tulang telah digunakkan dalam perubatan di hospital Tanahair adalah pada tahun 1987. Sel Stem darah tali pusat pula mula digunakkan di hospital tempatan pada tahun 1997. Setakat tahun 2006, Registry Transplantasi Kebangsaan telah mencatatkan 1,174 kes kegunaan sel stem yang dilaporkan oleh hospital-hospital tempatan Kerajaan dan swasta.

Pada tahun 2006, StemLife telah berjaya disenaraikan di bursa saham BSKL dibawah MESDAQ dan disenaraikan sebagai Stok Syariah. Pada tahun itu juga Jawatankuasa Etika Penyelidikan dibawah naungan KKM dan MOSTI telah mengeluarkan ’Garispanduan Penyelidikan Sel Stem’. Garispanduan ini juga menyatakan hasrat Kerajaan untuk menyokong dan mengembangkan penyelidikan sel stem dalam Negara.

Setelah terbukti kejayaan StemLife, beberapa lagi bank swasta sel stem telah mula beroperasi termasuk pembekal sel stem haiwan. Ramai yang mula membuat kenyataan dalam akhbar-akhbar tempatan mengenai keberkesanan produk mereka. Dalam usaha untuk menjaga kepentingan pengguna/pesakit, pada bulan Mac tahun 2008, Kementerian Kesihatan Malaysia telah mula mengeluarkan lesen dibawah Akta PHFS 1998 lalu menghadkan operasi kepada 4 bank sel stem darah tali pusat sahaja. Bersamaan dengan itu juga, KKM telah menerbitkan ’Piawaian Kebangsaan - Bank Darah Tali Pusat dan Transplantasi’.

Laporan juga menyatakan bahawa pihak KKM sedang dalam proses menyediakan ’Garispanduan Penyelidikan dan Terapi Sel Stem’ serta ’Piawaian Kebangsaan - Terapi Sel Stem’.

Pada masa akan datang, kami berpendapat Terapi Sel Stem akan menjadi salah satu dari Tiga teras perubatan setanding dengan bidang famasi dan bidang pembedahan. Sejarah perkembangan Kedua-dua bidang ini telah berkurun/berabad lamanya. Sesuatu ubat/prosedur pembedahan selalunya mengambil masa 10 tahun keatas untuk diselidik dan disahkan/diluluskan kegunaan dan keberkesananya. Sejarah bidang Sel Stem Dewasa/Sum-sum Tulang sudah dekat 50 tahun manakala Sel Stem Darah Tali Pusat dekat 20 tahun. Ini adalah jankamasa yang amat singkat kalau dibandingkan dengan bidang famasi. Tetapi, keberkesananya telah diiktiraf di seluruh dunia. Sekurang-kurangya 100,000 pesakit setahun menggunakkan sel stem di seluruh dunia.

Adakah statistik ini memberangsangkan? Sudah tentu. Bagi saya, jika saya berhadapan dengan statistik sedih penyakit kanser darah seperti Lukimia, sudah tentu saya akan berusaha dan merayu supaya pakar-pakar tempatan mencuba teknologi sel stem terkini yang diamalkan di luar negara dan bukan hanya mengesyorkan teknologi yang sudah lama diamalkan. Sampai bila hendak ketinggalan 20 tahun?

Stem Cell Snake Oil? When a rotten apple spoils the whole barrel

There's no need to tell me that this blog site seems to be gathering a rather thick layer of dust since we last posted in April. It certainly isn't for the lack of interest but simply the lack of time and sleep!

Well, there's been lots happening in the stem cell world and if you've been keeping up with the news (and if you've been doing that, you definitely have had more time than I have) you'll have seen the many various promotions by new companies, the new technological adoptions and the wide-scale criticism of certain organizations who offer purported stem cell treatments without credible medical data or volunteer themselves for western methods of accreditation and inspection.

There has been most unfortunate reports the media, highlighting the cases of families being "conned" into stem cell treatments and spending hard-earned or hard-raised cash flying to exotic countries for injections. The media certainly portray these families as having no money and no idea as to what they are getting into and are therefore considered "victims" of scams.

It does seem to me that some of these criticisms of the various centers, while valid, give too much credit and sympathy to the patient. Patients who are willing to spend that amount of money should certainly conduct their own research first and opt to try something experimental, knowing that the outcome at best may be to return home safely after a vacation from their usual drudgery and hopefully no worse than what conventional drugs or palliative treatment can offer.

Some of these centers have claims of miraculous cures and patients who have shown remarkable improvements in their conditions. What I'm wondering is whether these centers have been invited to the table to present their work and explain why they think a particular treatment worked in some patients and not in others.

The stem cell world is still new and many issues surrounding the understanding of how stem cells migrate and assist in tissue regeneration have yet to be elucidated.

In any case, the jury is still out and therefore it all depends on whether you believe in "innocent until proven guilty" or "guilty until proven innocent". Criticism is always easier when you haven't got a sick child or a parent with an incurable disease. Desperation itself is a powerful motivating factor to try anything or to try nothing, and is the individual's or family's decision.

One of the biggest problems that a patient faces is access to information and doctors who are really willing to discuss the issues knowledgeably and openly. Doctors could also inform the patients that there are no guarantees in any medical treatment and in the cases of the currently "incurable", inform the parents of the basis of the disease and why stem cells may or may not be able to help.

A short list of questions that might be useful for potential patient to ask are:

1) Are these treatments performed in licensed hospitals?
2) Who are the doctors performing the treatments?
3) How are the stem cells applied?
4) What is the source of the stem cells?
5) Can I see your laboratory facility? (sterility controls, infectious disease etc)
6) Can my medical doctor speak with your medical director?
7) What is the track record of your patients? (success vs. failures, how many still alive?)
8) What other therapies/ treatments do I have to undergo?
9) Adequate back-up facilities for complications?

There are no right or wrong answers but its good to understand the main motives of the providing organization to know whether it is purely for profit and the injections may only be saline.

Sel Stem Darah Tali Pusat Bayi - diiktiraf di seluruh Dunia!

Sel Stem Darah Tali Pusat Bayi - diiktiraf di seluruh Dunia!

Assalamualaikum WBK,

Salam Sejahtera kepada rakan-rakan saya sekelian, ibu-bapa, bakal ibu-bapa, pengunjung/pembaca blog ini.

Beberapa hari kebelakangan ini kami telah mengambil bahagian dalam program-program ceramah topik Sel Stem Darah Tali Pusat dan kegunaanya dalam menangani masaalah Leukemia dan Talasemia di beberapa lokasi yang telah dianjurkan oleh beberapa organisasi berwawasan sempena Hari Ibu yang diraikan beramai-ramai bulan ini.

Organisasi termasuk Bank Negara, Pusat Perubatan MUIP dan Sekolah Sri Ayesha. Ketiga-tiga telah mengundang kami sebagai Pakar Sel Stem kerana ingin mendapatkan penjelasan yang terkini. Para hadirin ketiga-tiga program ingin penjelasan mengenai pengiktirafan dan status perkhidmatan Sel Stem darah Tali Pusat. Bersama-sama kami di Bank Negara adalah Ratu Jazz Sheila Majid yang telah turut serta di majlis ini kerana beliau juga telah menyimpan Sel Stem Darah Tali Pusat anaknya Khalifah tahun lepas dan ingin mengumumkan kepada peminat beliau mengapa beliau telah memilih untuk menyimpan sel stem darah tali pusat anaknya.

Sudah tentu ramai di antara anda telahpun membaca dalam akhbar-akhbar tempatan tentang penggunaan Sel Stem Binatang untuk mengubati penyakit-penyakit yang sering dihidap zaman ini. Saya berpendapat jika adanya Sel Stem sendiri ataupun yang diderma oleh saudara lain, kita tidak perlu menggunakkan Sel Stem Binatang. Sudah tentu ia tidak menjadi pilihan saya. Kita sering mendengar tentang penyakit ’Bird Flu’, ’Jangkitan Nipah Virus’, ’JE’, dan ’Mad Cow Disease’ yang mungkin menjangkiti manusia dan ada yang telah membunuh ramai - adakah mungkin selamat penggunaan sel stem binatang? Saya masih was-was dan menasihati semua supaya berwaspada. Jika betul ada kajian yang membuktikan keselamatan, kesahihan, dan keberkesanan sel stem binatang digguna bagi manusia dan jika betul ia diiktiraf negara Eropah seperti UK, di USA atau di Australia barulah saya akan menimbangkan penggunaanya. Ini juga jika sudah betul kesesakan dan betul tiada pilihan lain dan juga jika tidak melanggar hukum syarak. Teknologi terkini amat canggih dan mampu memberikan pelbagai pilihan semulajadi seperti sel stem sendiri, buat masa ini dan juga di masa hadapan.


Sel Stem darah tali pusat dan sum-sum tulang yang diderma oleh sahabat kita atau disimpan masa bayi dilahirkan yang sering diggunakan oleh pakar-pakar perubatan telah pun mendapat perhatian dan penerimaan oleh pihak Majlis Kebangsaan Bagi Hal Ehwal Agama Islam.

Penggunaan Sel Stem Darah Tali Pusat juga telah diterima oleh Kementerian Kesihatan Malaysia. Semenjak tahun 2002 lagi kerajaan telahpun mengiktiraf kepentingan sel stem darah tali pusat apabila Pusat Darah Negara telah memulakan perkhidmatan bank sel stem darah tali pusatnya di Pusat Darah Negara di Jalan Tun Razak Kuala Lumpur. PDN telah berganding bahu dengan Hospital Besar Kuala Lumpur dimana ibu-ibu yang bersalin di Hospital Besar KL boleh menderma darah tali pusat mereka kepada PDN.


Pada lewat tahun 2007, Menteri Kesihatan pada masa itu telah pun mengumumkan untuk meningkatkan lagi mutu perkhidmatan dan menambahkan saiz simpanan Sel Stem Darah Tali Pusat Kerajaan di Pusat Darah Negara dan juga membina bank sel stem darah tali pusat di Sg Petani, kedah. Menteri Kesihatan juga telah berjanji untuk meningkatkan perkhidmatan transplantasi sel stem di hospital-hospital Kerajaan tertentu. Pihak KKM juga telah mengiktiraf kewujudan Bank Sel Stem Darah Tali Pusat Swasta apabila telah melesenkan perkhidmatan StemLife Berhad di bawah Akta Perkhidmatan dan Fasiliti Perubatan Swasta 1998.

Terapi sel stem, transplantasi sel stem ataupun pemindahan sel stem telah mula diamalkan di Malaysia lebih dari 15 tahun yang lepas. Pusat perubatan Universiti-Universiti tempatan dan Hospital Kerajaan seperti Hospital Besar Kuala Lumpur sudah lama dan sering mengamalkan prosedur ini. Ianya masih belum kerap dilakukan atau diumumkan pihak media kerana masih ramai gagal mendapat bekalan sel stem.

Perangkaan dari NDMP-USA(Program Pendermaan Sum-Sum Tulang Nasional–USA) bagi tahun 2007 adalah lebih 6,000 pesakit mencari sel stem di bank-bank darah kerajaan USA setiap hari tetapi hanya 648 berjaya mendapatkan sel stem untuk menyelamatkan nyawa mereka. Setiap tahun sekurang-kurangnya 40,000 hingga 50,000 pesakit diseluruh dunia berjaya mendapatkan perkhidmatan pemindahan sel stem bagi penyakit-penyakit barah darah seperti Leukemia dan kepincangan sistem darah seperti Talasemia.

Kini, beberapa Kerajaan Negeri di Negeri-Negeri di bawah Negara USA telah pun menyarankan supaya doktor-doktor menasihati ibu-ibu tentang keggunaan sel stem darah tali pusat dan peluang sekali seumur hidup mereka. Peluang ibu-ibu untuk membuat pilihan samada menderma kepada bank darah Kerajaan untuk keggunaan umum atupun menyimpan di bank darah swasta untuk keggunaan keluarga sendiri.

20 tahun lepas, sel stem darah tali pusat hanya diggunakkan untuk menyelamatkan pesakit-pesakit bagi Satu penyakit. 10 tahun lepas, bilangan penyakit telah meningkat ke lebih kurang 10 penyakit. Kini, anggaran oleh Prof. Dr. Colin McGuckin dari Newcastle University adalah 85 penyakit dan jumlah penyakit akan makin meningkat.

Jadi, terapi sel stem darah tali pusat bayi bukanlah suatu prosedur amalan alternatif tetapi adalah prosedur biasa diamalkan dan diiktiraf pakar-pakar dan kerajaan-kerajaan di seluruh dunia.

Sekian buat masa ini......Wslm..WBK.

Viacell chose SEPAX

Well, it wouldn't be fair that other automated systems aren't discussed on this blog.

A burning question you must all have is:

What systems are all the other cord blood stem cell companies using?

Well, last year, Viacell announced in a short brief that they were integrating automation into its existing closed processing system using the SEPAX system, designed and manufactured by BioSafe, a Swiss rival of Thermogenesis.

The announcement stated that:

"SEPAX is the only FDA cleared cord blood processing system. Biosafe received FDA clearance in January 2007 and European CE mark approval in 2001."


THE SEPAX MACHINE: WHAT IS IT?

The SEPAX automated processing system is an all-in-one machine which is achieves a similar outcome of stem cell separation through an in-built centrifugal technology. It is approximately 14 Kg in weight (2 year old baby) and reminds me somewhat of a large square automated rice cooker (the newer Sanyo versions, that is).

The separation of stem cells from other blood components is achieved in a central core which spins the blood at high speed and through an optical reader, squeezes the separated components into the various compartments until the process is complete (watch the Quicktime animated demo). SEPAX kits are single use (just like AXP) and come with an option of storage bags, although it is rumoured that the kits will soon only come with a single compartment bag as Thermogenesis is revoking permission for the dual compartment design use (business as usual for public banks but potential consumer's angst in private banks).


THE PROS AND THE CONS

Let's start with the Pros.

1) The machine does away entirely with a centrifuge (no Beckmann or Sorvall)
2) One unit processed at a time
3) Portable
4) Closed system
5) Single disposable kit
6) No requirement for clean room
7) Used and endorsed by major european cord blood banks affiliated with Netcord*

The Cons.

1) Each unit takes approx 40 mins to process
2) One machine processes one unit at one time
(i.e. if you have 1 machines and 10 units, it will take you approx 5+ hours to complete the lot, more machines = more costs)
3) Possible breakdown of light detector (replacement downtime?)
4) Limitation of single compartmented storage systems
5) Technical oversight to ensure that the initial connections are placed correctly
6) Price (the euro has been incredibly expensive since last year)
7) Service when things go wrong (specialized engineer required from Switzerland)

CONSIDERATIONS FROM THE USER'S PERSPECTIVE

Both the AXP and the SEPAX have their pros and cons, and as a potential user, I'm interested in knowing the breakdown rates and other problems banks have in using the system. These are usually not disclosed and the user takes on the risk to find out. Unlike public banks which can afford to discard units which don't turn out right, private stem cell facilities have zero tolerance for error as every single one hurts both the client and the company's balance sheet. Additionally, if the system does not work out for the company for whatever reason, the expensive asset has to be written off (may cost millions) which would be an extremely painful decision to make.However, unlike the AXP system, the SEPAX system has been in use for a while and has not released any public recalls of their product. Hence, the only reason that I can think of for its slow uptake in the rest of the world is that unlike Europe, which promotes public banking largely for blood cancer use, America and the rest of the world is promoting cord blood stem cells for regenerative use- hence the need for a multi-compartmented bag- which is a different concept entirely.


PROFIT & LOSS

Certainly all companies selling the automated systems would stand to profit greatly from entering the cord blood stem cell market. Cord blood stem cell banks can still use generic products on the market, making it relatively affordable to bank as long as the team is technically competent. Now, automated systems will increase general standards of quality for those with less well trained staff (its a matter of practice and the total experience) but it also pushes prices up for the consumer or makes it less profitable for smaller operators. Public banks will also need to campaign for more funds in order to buy new systems and costs of processing will need to be revised from previous proposals.

For now, the small number of options in automated systems commands a forced loyalty as each system only accepts their own product. Many of the stem cell banking services that face the consumer directly will await the day that there is a generic design of standard quality which can be used with any machine, which will be more open to price transparency. Of course, that day may still be far away until either governments have budget surpluses to devote to a huge volume of public banking (when it takes precedence in funding over other healthcare priorities) or legislate to provide a conducive environment for the public to exercise their choice to bank privately should they wish to.

KNOW WHAT YOU'RE PAYING FOR

There is no doubt in my mind that automation is inevitable at some point but let's not forget that this is still version 1 with potential to move to version 2. In the meantime, I'd like to see who and how the AXP system and SEPAX system is used in private hands, and whether it is used according to manufacturer's recommendation** to achieve the desired result.


*Prof. Eliane Gluckman's - the first cord blood stem cell transplanter- facility Eurocord uses the SEPAX system, in direct rivalry with AXP whose public endorser is the New York Cord Blood Bank led by Dr. Pablo Rubenstein who developed cord blood storage procedures in the US.

**Manufacturers recommend certain minimum volumes and maximum volumes to be used with their system. Any deviation of this will not result in the promised outcomes, hence clients who are paying more for the promise of this system but don't meet the criteria will still ultimately be getting manual processing (which works well in a competent facility but not in one where the practice is limited).

The point of these systems is also to provide a "functionally closed" system of processing and there certainly wouldn't be any point in using the automated system if you had to transfer the cells from the final bag into a different storage method (e.g. vials) at the end, which would break it into a "functionally open" one instead.

Bioengineering like the movies: Stem Cell Capturing Gadget

I'd hate to sound as if I was brought up on an entertainment diet of Hollywood movies, but back in the 1970's to 80's there was a real revolution in cinematic production and audience interest that led to a cult following of the science fiction genre.

Film directors often take what's probable in science and stretch them to the limits of our imagination, engaging us to just reflect on not only how far we've come but also how much further we can aspire. This next entry is a tribute to the 1987 movie "Inner Space"*.




In a recent announcement, MIT's bioengineers have designed an implantable device that is capable of capturing pure samples of stem cells from the circulating blood. The device is described as "a length of plastic tubing coated with proteins" which has been experimentally implanted into the bloodstream of rats.

The more accurate medical description of this plastic tubing is known as a "shunt" and the method of implantation would most likely involve the severance and reconnection of a small but high through-flow blood vessel. The proteins -known as selectins- attract and trap specific cells with the right signals on the surface (imagine a sticky mat). The cell capture devices are developed by chemical engineers led by Associate Professor Michael King from the Biomedical Engineering department at the University of Rochester. The technical details will be described in the March edition of the British Journal of Hematology.

(personal note: Mr. B.C. this is for you.)


WHY IS THIS DEVICE IMPORTANT?


The medical impact of this device could weigh in for cancer patients who may need to use autologous (one's own) stem cells for their treatment. These cancer patients are treated with chemotherapy to reduce and eliminate as many of the malignant circulating cancer cells as possible from the bloodstream and bone marrow. The treating doctor will collect the patient's own stem cells during this period of remission when the cancer load is at its lowest.

The patient's own stem cells are stimulated using GCSF (read about it here) and the stem cells are harvested and stored in anticipation of the possibility that the cancer cells will multiply again, requiring another round of chemotherapy which may damage the existing healthy marrow further. The collected stem cells will be infused back to the patient to ensure that the patient has sufficient stem cells to repopulate and replenish the marrow, thereby restoring normal cell levels to the bloodstream.

To address the concern that perhaps cancer cells from the patient might also be collected in the same fraction as the healthy stem cells (impossible to distinguish during harvesting) this device could lend a hand to filter out the cancer cells inside or out of the patient's body, i.e. the cancer cells would travel around the bloodstream until they reach the shunt, where they would then be immobilized.

Note though, that the inventors have conceded that this device will not be able to collect enough stem cells for a transplant, therefore the customary stem cell collection procedures will still need to be performed.


SOME INTERESTING STATISTICS


According the A/Prof. King, the shunt placed in an non-GCSF induced rat in a 2 hour period enabled the capture of 3-4 times the number of usual stem cells obtained in normal circulating bloodstream (approx 1%). Hence the device is thought to attract and specifically retain a significantly higher number of stem cells.

This stem cell number could be significantly higher in patients who have been mobilized.


WHAT ELSE CAN IT DO?


Well, it is a concept device which will be as good as its selectin coating. A/Prof. King has already forecasted the use of the device in trapping specific cancer cells in the body to prevent metastatic spread and layering in proteins which could help steer cell development processes by differentiating them while passing through the shunt. (analogy: think sticky mats for dust, sticky mats for cockroaches, sticky mats for cat fur...all requiring different levels of stickiness for its target)



WHEN CAN I BUY IT?


The entrepreneurial A/Prof. King has already started a company by the name of CellTraffix and the anti-metastasis implants are set for animal trials later this year in collaboration with bioengineers Professor Jeffrey Karp and Robert Langer at Harvard and MIT who will develop stable selectin coatings that will last over months than days. Meanwhile, the CEO of CellTraffix, Tom Fitzgerald has already announced that the company's first product for researchers to capture stem cells or cancer cells for lab experimentation will be marketed by early 2009, with clinical testing of the anti-cancer coatings in 2010.


Read how a chance encounter between a bioengineer and a haematology clinician gave rise to this work and watch the cells being captured here (note that you will need a high speed broadband connection as the video files are rather large).


*Why does this remind me of the movie Inner Space I hear you ask... well the term cell capturing device often conjurs up the image of a little machine (like the exploration submersible the protaganist uses) to grab and hold onto cells in circulation :)

Viacell Acquired by Perkin Elmer

Now that PerkinElmer (PE) has purchased Viacell, the company best known to me for its PCR machines* now owns the distribution arm of Viacell's cord blood stem cell storage unit- Viacord. The announcement of Viacell's takeover, valued at USD 300 million (approx 960 million MYR) was certainly a whole lot more than what Celgene paid for LifebankUSA which was closer to USD 60 million a few years ago.

Viacell had several subsidiaries; one focusing on R&D for cord blood expansion and differentiation; one focusing on therapeutics; another focusing on freezing and storing women's eggs (Viacyte) and its most well known backbone cord blood stem cell banking service Viacord.

PE's intention is essentially to sell off Viacell's stem cell therapeutic business, the Viacyte service, probably wind down the R&D aspects of the business and to ride on Viacord's cord blood banking strengths.


WHY ACQUIRE A CORD BLOOD COLLECTION SERVICE?

PE acquired two companies last year namely Macri Technologies and NTD Laboratories, the former developed a genetic screening kit called Ultrascreen and the latter company offers the screening test at their facilities. In the latest addition to its stable, PE's acquisition of Viacord is to develop an end-to-end package for prospective parents who are shopping for cord blood storage and will also be provided the option of having their babies screened for freeBeta hCG (a peptide hormone indicative of first trimester down syndrome prenatal risk assessment). The chairman and CEO of PE indicated that the acquisitions represent the next steps in their initiative to build a comprehensive screening and diagnostics capability in maternal healthcare.

PE also intends to expand their genetic screening tools that test the cord blood collected for any conditions which are potentially treatable with stem cells. PE also plans to take advantage of Viacell's established distribution consumer network which is doesn't have- allowing it direct access to patients and clients instead of having to rely on doctors and hospitals to sell their product.


GROWTH IN THE MARKET

According to the Boston Globe, Viacord expects to generate less than USD 70 million in sales but Perkin Elmer believes that the cord blood banking market could reach more than USD 1 billion within the next five years. Additionally, PE's CEO also said that the genetics screening business is expected to account for more than 10% of PE's annual sales which totals USD 1.7 billion, and is growing faster than PE's business as a whole.


DRUG GIANTS ARE IN

PE plans to sell Viacyte (egg freezing and storage technology) to EMD Serono which is part of Merck Serono and Viacell's therapeutic business to another drug giant- possibly Amgen.


The CEO of PE Gregory Summe said that Viacord would continue to run independently of PE but that PE may provide additional funding and resources to accelerate Viacord's growth. With PE's generous offer of USD 7.25 per share, I wonder if the management team have decided to retire and let PE's management takeover the day to day operations of the company. Will PE succeed in this latest corporate move? It remains to be seen how the acquisition of Viacord's network can integrate with the screening services. In direct comparison, Celgene's acquisition of LifebankUSA hasn't enabled it to boost its position to No. 1 in the US yet.


*PerkinElmer's PCR machines were the most loved of the lot in the research lab where I used to work. There were long queues for the machine as it was known to give beautiful amplification sequences at high yield. Despite its bulky shape, the best labs still insist on having at least one version of the machine.

AutoXpress System: Not Yet A Winner for Thermogenesis Corp

When Thermogenesis announced that they had pioneered an automated system (AXP) for the processing* of cord blood stem cells, we were all quite excited that the industry was indeed moving in this direction. StemLife has been banking babies' cord blood stem cells in the FDA approved Thermogenesis cryo-storage bags since we started the service in Malaysia in 2001, hence the adoption of this system would seem a natural progression for us.

WHEN BEING FIRST IN TECHNOLOGY ISN'T NECESSARILY BEST

However, just like any system update (in IT terms), the question remains as to whether one wants to take a chance on being an alpha user or to wait for the beta version. StemLife's position is that we usually like to wait for all the bugs and kinks to be sorted out before we put our babies' stem cells on the line. There are 2 automated systems available on the market to stem cell processing laboratories namely Biosafe's Sepax System (Sepax) and Thermogenesis's AutoXpress (AXP).

Both systems have been in the Malaysian market for about a year and we've been evaluating them in terms of uptake internationally, performance and consistency of service. Despite the US largest cord blood stem cell provider- Cord Blood Registry- releasing results of 97% and above recovery rates using the system, many stem cell companies in the US (Thermogenesis's home market) and abroad have yet to fully convert their existing processing systems to the AXP system or Sepax system.


I should point out at this stage that the main advantage of using the AXP system (apart from its automatic sensor which makes recovery rates more consistent) is that it is pretty neat because it automatically puts all the stem cells into the thermogenesis cryo-storage bag in one closed loop (if you wanted to store it in any other container, you would have to syringe out the cells, defeating the functionally closed system that the sterile processing set is supposed to provide).


Upon following the most recent news released by Thermogenesis, it appears that thus far the uptake has been lackluster despite big announcements to market the product through General Electric Healthcare. This lackluster sales performance (due to problems with production and slow sales) for the year of 2007 has resulted in a doubling of the net loss at Thermogenesis Corp in the fiscal quarter ending in September.


GREAT, SO WHY AREN'T ALL CORD BLOOD STEM CELL BANKS USING IT?

I don't know if all cord blood stem cell service providers feel the same way but our reasons for a methodical evaluation are as follow:

a) COST
- It requires the acquisition of new expensive apparatus and equipment
- Technical fragilities (rate of machine breakdowns etc)

b) COMMITMENT
- All processing sets must be purchased from GE alone (effective monopoly)
- Hardware and Software and proprietary to Thermogenesis (data monopoly)

c) CLIENT
- StemLife already promotes the bag storage system but some other cord blood banks are still marketing a non-bag system. Hence Thermogenesis and GE need to convince those banks to adopt the bag storage system.

d) CONSIDERATIONS
- How committed are Thermogenesis and GE to this technology given on-going losses and opaque trendline?
- Price control (we're outside of the US and would be affected if there are currency fluctuations)
- How committed are Thermogenesis and GE to serving the needs of non-US clients? (which accounts for a smaller market)


FINANCIAL IMPACT

According to the article:

Revenue fell to $3.6 million in the quarter, down from $4.3 million in the same three months of 2006. The quarterly net loss swelled from $1.1 million, or 2 cents per diluted share, in last year's initial quarter to $2.3 million, or 4 cents a share, in the same period of fiscal 2008.

Thermogenesis's CEO William Osgood attributed the decline of the company's revenue to a series of false negative results in quality tests for the bags used in the AXP systems (leading to a delay in shipments) and the sale of only 3 BioArchive blood storage systems by GE healthcare, which he said was "significantly below target".

I wonder what the Thermogenesis target given to GE healthcare was, given that the challenges of the system remain and that most cord blood stem cell banks - both public and private- really have to operate on a tight budget and make the service available given their low margins.



*The processing of cord blood to obtain the important and critical stem cell numbers is lengthy (taking between 4-6 hours in total per unit if performed manually) and there is a level of operator dependent subjectivity (good, when you have many units to work on and experienced and well practiced laboratory scientists). This operator-guided process has been in use since the industry pioneered by the founders of the New York Cord Blood Bank in the 1990's.


**The FDA and American Association of Blood Banks (AABB) recommend the Thermogenesis cryo-bag for storage which most of the cord blood stem cell companies have adopted, but not all stem cell companies internationally or in Malaysia are using thermogenesis bag processing systems, instead they have promoted storage in vials, which implies that the AXP system isn't required.

The Best Gamble in Las Vegas: Bet on Your Stem Cells

Neostem, a company formerly known as Phase3Med, based in New York (USA) which collects and stores adult stem cells has been around for quite a while. One of their directors was here in Malaysia 3 years ago at one of the locally organized biotech symposiums and expressed a certain interest and admiration for the work that we have accomplished thus far.


LAS VEGAS MEDICINE

After a short hiatus about two years ago where there was a change in management and ownership, the company has started to make regular press announcements about their expansion of collection services in the US in collaboration with aesthetic doctors. Neostem held a press conference last Friday (Oct 23rd) which was sponsored by the Nevada Development Authority and the University of Nevada and a few local companies. Neostem used the opportunity to present to the Nevada Biotechnology and Bioscience Consortium to educate the region's medical and scientific community.


The collection site is apparently sited near the Nevada Cancer Institute and the Nevada Neurosciences Institute. Its CEO Robin Smith said that its expansion in Las Vegas was quite obvious given the large size of the city's population, its tourist attraction status and that tourists also visit for the health and spa-oriented services offered by the hospitality industry. Neostem's target clients for adult stem cell banking include anyone concerned with their long term health or well-being. They are also targeting people concerned about possible exposure to radiation.



MONEY MATTERS

Neostem listed on the American stock exchange on the same day as the Nevada announcement, is unfortunately already trading down and has a market capitalization of 14 million USD. The rapid expansion over the last three years has been loss-making for Neostem (approx. twenty million US dollars) according to its last audit in March. Most of it was operating expenses (expensive infrastructure and qualified personnel requirements).


However, medical director of the Las Vegas facility, Dr. Ivan Goldsmith expressed his enthusiasm to target both residents and tourists and convince them that storing their own stem cells for their future might be a better bet than the gaming tables.


He said: "The odds are far greater that you will eventually be a winner having your stem cells banked"



StemLife offers adult stem cell collection and banking in Malaysia and Thailand. If you're in the region and interested in this service, give us a call. :)

ESI Abandoning Embryonic Stem Cell Research and the Start of a San Franciso based Embryo Stem Cell Bank

This entry relates to 2 separate news articles.

I read with some regret last month (sorry, only had time to write it up tonight) that the company known as Embryonic Stem Cell International (ESI) folded up its embryonic stem cell research program after a 5-year attempt to get the research off the ground.

The company announced that it had to abandon the work on therapies due to the lack of success and soaring costs. The aim by the original investors- namely the Singapore Government and the Australian Stem Cell Centre (a private investment group)- raised an impressive SGD 24 million (approx RM 50 million) and recruited Dolly creator Alan Colman as its CEO to lead the research effort.


DECISIONS AND REASONS

Professor Alan Colman was extremely honest in providing the reason for the company's decision, mainly that investors had lost interest due to:

a) any commercialization of its research in the short term was "vanishingly small"

b) the attempt to make well functioning insulin cells and cardiac muscle cells from embryos "proved really difficult" as each therapy would require a minumum of 1 billion cells for each dose

c) and that producing such a dose would be prohibitively expensive.


Other scientists comment that other problems with embryonic stem cells include scaling up the required number of cells and problem with immune rejection and the risk of tumour formation.


ESI MOVING ON TO OTHER NON STEM CELL ACTIVITIES?

ESI has not closed down however, according to this article Professor Alan Colman has tendered his resignation as the CEO, the company has since been taken over by its board of directors and its direction is now towards more revenue generating activities such as "drug screening and drug discovery" (which could mean that its services are rented out to the pharma companies).

Prof. Colman has moved onto a position in the Government which is responsible for stem cell research. He is now named as the Executive Director of the Singapore Stem Cell Consortium and the principal investogator at the Institute of Medical Biology. His focus now will be back to laboratory work (presumably he had to do more marketing and administrative work in the previous entity) and dealing with "all sorts of stem cells, not just human embryonic" he was quoted as saying.

I don't usually write about embryonic stem cells in this blog, but have decided that this piece provides some important perspectives on the topic of stem cell research. While the goals of embryonic stem cell research and commercialization are noble and the prospect attractive at first glance, the existing chasm in both its applications (still none confimed to-date) and its hype to the public has been far greater than any in adult stem cells. Investors will base their expectations on when they see the return of their investment, and these days even a 5 year business plan -with the best and most experienced names on board- can seem difficult to forecast.

Ultimately, investors look at revene generation and the company's bottom line to decide whether they wish to stick with it or cut their losses and find somewhere else to put their money. I admit that it is very difficult to assess what to look for in a biotech investment, most are research oriented and revenue will often seem like betting on a horse you know very little about.

And even if you do know a lot about biotechnology and science, understanding the business strategies and direction of the board and its management team is also critical to whether the company will be able to deliver on its corporate objectives. One may have the most wonderful idea in the world, demonstrated its usefulness in advancing the human race and yet have it sidelined due to factors concerning costs and the lack of adoption by the masses.


ANOTHER RISKY EMBRYONIC STEM CELL INVESTMENT?

This brings me to the next interesting snippet of news that I came across. It appears that since my partners and I started the company close to 6 years ago, there have been some others around the world who have decided that they like our company's name enough to either use it in its entirety or an approximation of it.

The headline of the news article screamed "PRIVATE STEM-CELL BANK IS A POOR INVESTMENT". The "stem cell bank" that the article was referring to was an embryonic stem cell company called StemLifeLine which offered couples undergoing IVF to transfer their unused frozen embryos to a company in San Francisco Bay.

The company will make a "personal stem cell line"*, providing clients with a way to "protect their future and the future of their children". A very, very bold statement indeed (surprising that the US Ministry of Health / Federal Agencies isn't restricting the use of these words?)

The journalist correctly points out in the article that although the cell lines are personalized, they would be personalized to the unborn embryo, not to any of its parents or siblings. Furthermore, they state that a minimum of 10-12 embryos would be required to yield a viable line (okay ladies, that's 10-12 eggs, which is what you ovulate in a year). The article states that on average each IVF cycle yields about 10 embryos which are used in an attempt for successful implantation. I've also heard that the success rate of a couple that chooses to undergo IVF is less than 30% in some cases, so most couples would use all the viable embryos to give the procedure the best chance... hence would the stem cell bank be saving the least viable embryos to create the stem cell lines?

The company plans to market its services through leading IVF centres and generate its revenue (although it doesn't state how much the charges are) by isolating, growing and storing frozen embryonic stem cells. Given that ESI has just announced its plans to switch out of this area, this company's investors and doctors seem not to have read about all the issues surrounding the reason why embryonic stem cells have failed to live up to expectations thus far.

For those who think that cord blood stem cell collection and storage is not a valuable investment despite its proven list of applications and future potential applications, this embryonic stem cell service sounds to be of an even riskier bet.

I'm not saying that the public shouldn't have a choice, its just that from a business perspective I wouldn't even know where to start on that embryonic risk vs. benefit chart for ethical counselling.


*The idea of creating personalized stem cell lines for patients has been mooted before, and collapsed. If you're interested, read this 2005 article, a subsquent article and this one.

Stem Cell Cure Claims for Cerebral Palsy and Down's Syndrome? Definitely NOT StemLife

There were a few statements made by the Malaysian Minister of Health reported in Malaysia's local newspaper "the Star" today. I'm writing this entry for StemLife clients, staff, shareholders and supporters who may be wondering if it relates to our work.

The Health Minister was quoted saying that there are those who claim that stem cells can cure diseases such as cerebral palsy and Down's syndrome, and a doctor who charged RM 25,000 for a stem cell treatment for these two conditions*.

Firstly, I'd like to put on record that StemLife has never claimed that stem cells can cure either of these conditions and that the doctor who administered the "treatment" worth RM25,000 is NOT in any way associated with StemLife.

Secondly, I'd like to address a few points that the article failed to mention (perfectly understandable as the journalist was reporting statements, not providing any analysis). The assumption that people only invest in something when there is a guarantee is largely incorrect, especially when it comes to one's health. One thing that can be certain is that in the medical profession, there is never a guarantee for a cure for any disease, whether the procedure concerns stem cells or not.

Further, the article and statements address the false hopes about what stem cells can do but fails to mention anything about the areas where stem cells have been used successfully in medical applications in Malaysia. This does not provide the Malaysian public with a pragmatic assessment of what facilities and procedures are available or possible in the appropriate medical context.

Thirdly, cord blood stem cell banking has been available in Malaysia over the last five and a half years -both privately and publicly- and the cost of storing stem cells has been declining, while the number of applications has increased significantly since it was first used in 1987. Therefore if one can afford the storage costs, then it is an option that can be considered.

Finally, in all fairness, no one should think of stem cells as a miracle cure for anything and everything. In all of human history, there has yet to be such a thing.

In case this topic is new to you, I'm including a few links below that I hope you will find useful. More stories can be found on this blog- try using the search box on the top left of this page or let me know if you have a particular question (we will refer to the medical specialists). We can't guarantee that we'll have an answer, but we'll be happy to share any information that we have on stem cells or its current applications.


Cord Blood Transplants from the National Marrow Donor Program, USA

Cord Blood Transplant Case as reported on CNN

Cord Blood Stem Cells as a Source for Adult Cancer Patients from the American Cancer Society

Cord Blood Registry (CBR)- one of USA's Largest and Oldest Cord Blood Stem Cell Banks Application Publication (click on the thumbnail on the right)

Cord Blood Stem Cell Transplant for Immune Diseases (from the British Medical Journal)

Statistics of Autologous Cord Blood Storage and Use by Dr. Frances Verter and Dr. Nietfeld (note that this is a .ppt file)


* I found this article published which might be one of the organizations that the Minister might be referring to.

Cord Blood Stem Cells for Broad Range of Medical Conditions

This news is interesting and reveals what cord blood stem cells are being used for on the other side of our planet. Cord Blood Registry (CBR), one of America's top 3 (or perhaps the top) cord blood stem cell storage companies has just announced the release of five units in the first quarter of this year for autologous infusions/ transplantation.


WHAT ARE THE STEM CELLS BEING USED TO TREAT?

3 of the infusions are for autologous use, namely Cerebral Palsy, Type 1 Diabetes, Auto-immune disorder related Autism.

2 of the infusions are for family members to treat Acute Myeloid Leukemia and Diamond Blackfan Anemia.


Statement from CBR's Scientific Director and Transplanter at University of Arizona

"The growing number of requests CBR is receiving for release of samples to the families who stored them is an important indication that the medical community is increasingly using autologous and genetically-related cord blood stem cells to help save lives," said David Harris, Ph.D., CBR scientific director and professor of immunology at the University of Arizona. "It is particularly encouraging to see the benefits of cord blood stem cells extend to patients with diverse unmet medical needs. This includes a number of regenerative medicine therapies which require a patient's own cells."


Interesting? Given the conventional options available, I'm certainly keen on knowing the patient outcomes.

Viacell ABANDONS Cord Blood Stem Cell Expansion Program

IS IT ENOUGH?

Whilst many cord blood banks rather unscrupulously hype up the possibilities of stem cell expansion (in order to get clients to store whatever they have and believe in their technology), I've always asked the StemLife team to take a very careful view of the science and the practical realities*.

[As a side note, here in Malaysia cord blood banks claiming to compete with us - operate on the cheap using non-FDA approved storage systems- promote the usage of vials as a storage medium on the pretext that cells can be selectively taken one vial at a time for future expansion. Read on to see why this is a disingenuous marketing ploy...]


THE CHALLENGES OF EXPANSION

The reason why StemLife has taken a cautious approach towards the expansion technology are three fold.

Firstly, in order to expand stem cells, you'll need enough cells -the more the better- in the first place. As a crude analogy, you'll need enough lactobacilli to make yoghurt (too little and it will take too long, allowing other bacteria to destroy the process).

Secondly, sterile technique is absolutely critical; when you're growing the cells, you have to make sure that it contains only the cells that you're growing and nothing else. This requires not only human precision, expensive facilities and sterile reagents, but most importantly, the money to maintain everything in exactly this pristine sterile condition (many, many zeros in any currency).

Thirdly, knowledge of cellular morphology and function is also very important. No one I know would like to risk having cells injected into the heart forming liver or kidney tissue instead. This means identifying the cells and providing the assurance that the cells are indeed stem cells and nothing else.

Hence, any organization, private or public has to be prepared to have deep pockets and a lot of patience when venturing into this technology.


HOW DEEP ARE YOUR POCKETS?

I've been following Viacell's (VIAC) progress in this area for some time, not only because they were one of the first stem cell companies to announce their sincere interest and demonstrate their financial committment in this area, but also because I was kindly shown around their big and beautiful facilities two years ago in Boston.

It is unfortunate therefore to see this press release by Viacell on their decision to terminate the cord blood stem cell expansion project CB001 despite its apparent reported success but on the grounds that the process and product was unaffordable and commercially inviable due to other alternatives.

"What's the alternative?" I hear you ask. The reason why Viacell made the tough commercial decision to cut their losses was that the preferred methodology by transplanters in the US is a dual cord stem cell transplant (using 2 cord blood stem cell units instead of just 1). The results of the expanded product were as good as and in some ways slightly better in the initial trial, but I suspect that the cost did not justify only small improved outcomes. I would say that it was a wise commercial decision by Viacell, and an acknowledgement that what scientists dream and love to do, is not always feasible for clinical practice.

I learned this a long time ago when I was still in research, that what looks good on paper does not necessarily transform into a money spinner despite the winning ideas and long hours of toil.


A GOOD CEO KNOWS WHEN TO QUIT

By cutting the budget for this research and focusing on service improvements, Viacell expects to finally achieve profitability in 2008 for the first time since their listing a few years ago (this is probably also true of many of the other cord blood banks which have committed much of their funding to very costly research, sacrificing their bottom line).


"Given these results and the shift in the treatment paradigm in transplant medicine from single cord to two cord transplants, ViaCell has made the decision not to advance CB001 in future clinical trials. As a result of the reduced clinical and development costs related to CB001, along with anticipated continued growth in its operating business, ViaCell expects to become cash flow positive in the first half of 2008."


Now, Viacell intend to focus on cord blood stem cells for cardiac applications, which I think is probably more interesting and may pose less life-threatening consequences for patients.


"We are committed to continuing to grow our operating business, advancing ViaCyte(SM) through a pivotal clinical trial, which, if successfully developed, will leverage our sales and marketing infrastructure, and working to advance our cord blood-derived cardiac program," said Mr. Beer. "We are already generating cash flow within our ViaCord business and we anticipate continued growth in 2007. As a result, given our reduction in clinical and development costs related to CB001, we expect ViaCord's contributions to the overall operation will allow us to turn cash flow positive in the first half of 2008."


So if you are specifically told by any stem cell company that stem cell expansion technology is available today, they aren't lying, but don't forget to ASK them whether:

1. Your unit baby's cord blood unit has sufficient stem cells to be expanded,

2. Who's offering the service (full due diligence here) and how successful the treatments outcomes have been and what assurances they provide otherwise;

3. And, specifically at what cost.


STEMLIFE BELIEVES IN CHOICES

The way I read the cord blood stem cell tea leaves, if you banked a unit of stem cells and it is not enough, seek other matching units to combine with your own or consider joining StemLife's adult stem cell banking program.

We believe in continually providing affordable and accessible options to our clients... and making stem cell banking a more than once in a lifetime opportunity. :)



*We do not turn away clients who express their wish to proceed but provide them with a cautious advisory to indicate if the stem cell counts are below what we would normally expect. StemLife also provides a full refund for those clients who decide not to proceed to store, and we usually ask them to let us know when they'll be having the next baby (success second time round).

StemLife has a joint research project with the National University of Singapore at very initial stages which differs from Viacell's approach, you can read more about it here.