Simpanan Sel Stem Darah Tali Pusat

Jawapan dari AABB......."Simpan Dalam Beg Bukan Vail" !!!!!

Assalamualaikum WBK,

Salam Sejahtera kepada rakan-rakan saya sekelian, ibu-bapa, bakal ibu-bapa, pengunjung dan pembaca blog ini. Kepada pembaca dari beberapa syarikat tertentu, janganlah cetak rompak atikel ini ya!

Kali ini Saya ingin menterjemahkan beberapa jawapan kepada soalan popular (FAQ) yang diterbitkan di laman web Persatuan Bank Darah Amerika (American Association of Blood Banks – AABB www.aabb.org). Ini adalah hanya sebahagian dari soalan-soalan yang dijawab. Saya akan cuba menterjemahkan soalan-soalan yang lain jika masa mengizinkan, Insyallah.

Sebelum bermula, Saya ingin menyatakan perbezaan antara Keahlian AABB dan Akreditasi AABB. Semua yang ingin boleh membayar fi dan menjadi ahli AABB, tetapi tiada sesiapa di Malaysia yang mempunyai Akreditasi AABB. StemLife bukanya ahli dan tidak mempunyai Akreditasi AABB. Saya tidak sesekali pun inginkan adanya salah faham. Saya hanya menterjemahkan FAQ yang ada dalam laman web AABB. Petikan dibawah menyatakan betapa beratnya kesalahan mengunakkan logo AABB tanpa kebenaran.

”Only cord blood banks with a current accreditation have permission to use the AABB logo, and AABB investigates reports of misrepresentation or fraudulent use once the misuse is brought to its attention.”

Apakah itu Sel Darah Tali Pusat?

Darah Tali Pusat (DTP), yang pada satu ketika dianggap sebagai sisa buangan, sekarang diterima sebagai sumber sel stem hematopoetik (sel permulaan hematopoetik). DTP serupa dengan sel stem hematopoetik yang boleh didapati dalam sum-sum tulang dan sistem saluran darah. Sel-sel ini boleh digunakan dalam transplantasi sel stem untuk menambahkuatkan sistem imun pesakit, sepertimana sum-sum tulang dan sel stem dari sistem saluran darah digunakan dalam transplantasi untuk merawat penyakit malignan seperti lukemia dan penyakit bukan malignan seperti kepincangan sistem imun dan anemia aplastik, dan penyakit kongenital seperti anemia sel sikle dan talasemia. DTP mengandungi bermacam jenis sel darah, tetapi, hanya sel stem hematopoetik (sel stem pembina darah) sahaja yang berguna dalam transplantasi. Kegunaan lain untuk sel stem DTP masih dalam fasa penyelidikan. Setiap sumber (samada sum-sum tulang, sistem saluran darah, atau DTP) ada kelebihan dan kekuranganya dalam transplantasi. Pesakit perlu berbincang dengan Pakar sel stem sebelum membuat pilihan tentang sumber sel stem paling sesuai yang sepadan dengan pesakit. Pilihan yang sesuai akan bergantung kepada opsen yang sediada dan keadaan pesakit.


What are umbilical cord blood cells?

Umbilical cord blood (UCB), once regarded as biological waste, has become an accepted source of hematopoietic stem cells/hematopoietic progenitor cells (HSCs/HPCs), similar to those found in bone marrow and peripheral blood. These cells can be used to replenish a patient’s immune system by providing stem cells for transplantation, just as bone marrow or peripheral blood stem cell transplants can be used to treat malignant diseases such as leukemia and non-malignant diseases such as immune deficiencies and severe aplastic anemia, and congenital disorders such as sickle cell anemia and thalassemia. UCB contains many types of blood cells but only the hematopoietic — or blood-making — stem cells in the UCB are currently useful for transplant. Other uses of UCB stem cells are currently undergoing research. Each source of HPCs (bone marrow, peripheral blood or cord blood) has advantages and disadvantages associated with its use in a transplant. Decisions about the most appropriate source of stem cells — which must be matched by tissue type to some degree with the recipient — must be made by each patient in consultation with his or her physician based on available options.

Bagaimana Darah Tali Pusat dikumpulkan?

Sejurus selepas bayi dilahirkan, tali pusat akan dikepit dan dipotong. Jarum akan digunakan untuk menyalurkan darah dari saluran vena tali pusat kedalam beg derma darah. Oleh kerana proses ini dilakukan selepas kelahiran bayi, tiada risiko atau sakit dijangka kepada ibu atau bayi. Pengambilan darah boleh dilakukan samada sebelum atau selepas kelahiran uri. Tekniknya berbeza sedikit sesama doktor pakar. Beg DTP akan dilabel dan dihantar ke makmal untuk diproses, dibekukan dan disimpan. Jumlah darah yang diambil berbeza tetapi seringkali dari 50 hingga 200 ml (lebih kurang separuh sehingga secawan penuh).


How are cord blood cells collected?

After the delivery of a newborn, the umbilical cord is clamped and then cut. A needle is then used to draw the blood from the umbilical cord vein into a collection bag. Since this happens after delivery, there is no pain or risk to mother or infant. The collection may take place either before or after delivery of the placenta, and techniques vary slightly among physicians. The UCB product is labeled and shipped to the processing facility for processing, freezing and storage. The volume collected varies but usually ranges from 50 to 200 ml (about one-half to one cup).

Adakah Darah Tali Pusat patut disimpan dalam Beg atau Vail?

AABB menggalakkan inovasi dan penambahbaikan teknologi dan tidak mengesyorkan mana-mana teknik atau pembekal. Ini termasuk koleksi/pendermaan, pemprosesan dan simpanan DTP. Oleh kerana kebanyakkan DTP disalurkan ke dalam beg atau cara simpanan berlainan sebelum dihantar ke makmal untuk diproses, tiada sistem yang ”Tertutup” sepenuhnya. DTP yang didermakan juga besar kemungkinan tidak sterile (bersih dari kuman). Oleh itu, kebanyakan makmal pemprosesan beroperasi diantara sistem separuh-tertutup atau tertutup secara fungsi (termasuk pada masa pendermaan). Tiada definasi yang diterimapakai secara umum untuk mengambarkan proses yang tertutup sepenuhnya. Operasi pengambilan dan pemprosesan DTP secara teorinya mengambilkira bahawa lebih banyak kali DTP terdedah kepada luaran, lebih tinggilah peluang untuk DTP terdedah kepada kontaminasi secara tidak sengaja.

Perdebatan beg lawan vail agak kontroversi. Kerja-kerja awal dalam pemprosesan DTP dalam makmal penyelidikan termasuk pengunaan vail-krio. Vail kecil yang lebih kurang sais jari halus dewasa adalah tidak begitu mahal. DTP dibahagikan ke dalam beberapa vail yang kemudian diletakkan ke dalam kotak kecil untuk disimpan.

Pengamal-pengamal sistem vail ini berpendapat bahawa jika bidang sains simpanan sel stem dapat dimajukan kelak dimana hanya sedikit DTP sahaja diperlukan, maka keseluruhan simpanan DTP tidak perlu dicairkan. DTP secara umum hanya dapat dicairkan sekali sahaja tanpa kehilangan banyak sel stem hidup. Vail juga memerlukan kurang ruang simpanan oleh itu membolehkan lebih DTP disimpan dalam satu tanki simpanan. Sebaliknya, vail kecil lebih sukar untuk dilabel dengan kesemua maklumat yang diperlukan.

Beg simpanan khas untuk simpanan krio sudah direka. Beg ini lebih mahal dan memerluka ruang yang lebih dari vail. Satu kelebihan penggunaan Beg Krio adalah ia merupakan sistem yang lebih ”Tertutup” dan bukanya ”Terdedah” jadi mengurangkan risiko kontaminasi yang tidak sengaja. Satu lagi kelebihan sistem Beg Krio adalah ia membolehkan DTP yang disimpan dalam Beg disambungkan terus kepada sedikit sampel DTP yang disimpan asing dalam ”Tiub/Saluran Bersambung DTP” (Integral Segment). AABB memerlukan DTP disambungkan terus kepada sedikit sampel DTP yang disimpan dalam ”Integral Segment” supaya ujian lanjutan dapat dilakukan keatas sedikit sampel DTP itu. ”Integral Segment” dapat dibentuk apabila tiub/saluran yang bersambung kepada Beg yang mengandungi unit DTP dikepit supaya terbentuk ”Segment”. Sedikit DTP diasingkan tetapi masih bersambung dengan unit DTP asal. Ini dilakukan supaya ujian lanjutan dan konfirmasi keatas sampel DTP dapat dilakukan jika diperlukan.

Ini adalah penting kerana bank-bank sering menerima beberapa beg DTP sekali gus. Walaupun prosedur telah diadakan untuk menghalang dari berlakunya apa-apa pertukaran beg yang tidak diingini tanpa diketahui, malah persoalan dan keraguan mengenai tuan punya sebenar DTP itu masih wujud.

Dengan adanya ”Tiub Bersambung DTP” (Integral Segment) yang bersambung terus kepada beg DTP, atau sistem yang serupa denganya, maka ini meningkatkan lagi tahap jaminan bahawa sampel DTP yang diuji memang dari sumber DTP yang asal. Ujian perlu dilakukan sebelum DTP digunakkan untuk rawatan transplantasi. AABB memahami bahawa bank-bank akan memerlukan masa dan perbelanjaan kos tinggi untuk bertukar dari sistem Vail kepada Beg, jadi, AABB telah memberi tempoh masa kepada beberapa bank untuk berubah, iaitu sehingga 1 Januari 2007. Bilangan bank yang diberi tempoh masa tambahan ini hanya segelintir dan hanya kepada bank yang telah menunjukkan pelan program pertukaran sistem dari Vail kepada Beg.

Simpanan dalam sistem lain: Dengan adanya perubahan teknologi, sistem simpanan baru mungkin akan direka kelak yang memenuhi kehendak dan tujuan piawaian. Tujuan piawaian adalah untuk memastikan supaya sampel DTP yang perlu diuji memangnya diambil dari Beg DTP yang sama. Sistem-sistem baru ini perlu diselidik dan diuji samada ianya memenuhi tujuan dan keperluan yang ditetapi oleh Unit Program Piawaian Terapi Sel AABB.

Should cord blood be stored in bags or vials?

AABB encourages innovations and improvements in technology and does not endorse any one method or manufacturer over another. This includes encouraging improvements in the collection, processing and storage of UCB products. Since most products are collected into a bag or other container before transfer to a processing facility, no system is completely “closed.” Even the product (UCB) entering the container may not be sterile. Therefore, facilities operate on a spectrum of semi-closed or functionally closed processing (including collection) and there is no uniformly accepted definition or criteria to define such a system. The practice is based on the theoretical deduction that the number of entries or exposures to the environment that a product receives, the higher the chance for accidental contamination.
The bag versus vial storage debate is quite controversial. Early work with cord blood processing in research labs included the use of “cryovials.” These small vials are about the size of an adult pinky and are relatively inexpensive. The UCB product is divided among several vials, which are usually placed into small boxes for storage. Proponents of this storage container assert that if science ever advances to the point where only some of the product is needed, the entire UCB unit will not have to be thawed. Products can generally only be thawed once without losing a significant number of live stem cells. The vials also occupy relatively less storage space and, therefore, permit more products (patients) to be stored in the storage tank. On the other hand, the small vials may be more difficult to label with all of the required information.
Specially designed bags intended for cryostorage have also been developed. These bags cost more and may occupy a larger amount of freezer space than vials. One advantage of using bags is that they render a more “closed” rather than an “open” system, thereby reducing the risk of accidental contamination. Another advantage to the bag system is that it permits the unit to have integral segments of tubing. AABB requires that integral segments be attached to cord blood units for subsequent testing. Integral segments are created when the tubing leading from the storage container is sealed to provide little portions or “segments” of product, which can be used for subsequent or confirmatory testing of the product if needed.
This is important because banks sometimes receive several products at once, and while procedures are in place to prevent mix-ups, questions regarding identity may occur. The availability of attached segments or an equivalent system provides a higher level of assurance that the test sample material can be traced to the original product if needed for confirmatory or additional testing before the product is distributed for transplant. AABB recognizes the investment of resources required to switch from vials to bags and, therefore, has granted variances to a few facilities until Jan. 1, 2007, to give them time to implement the change. These variances were few in number and only granted to those that presented a plan for implementing the change.
Other containers: As technology evolves, other containers or processes may be developed which meet the intent of the Standards. The intent is to ensure that the sample for additional testing is from the product. Such methods would currently require review and approval by the AABB Cellular Therapy Standards Program Unit.

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.

US Recall News: AXP AutoXpress Cord Blood and Sick Cow Meat

In this week alone, I've received two articles from friends and colleagues informing me on the latest in a string of bad news from the US.

The first article was about Thermogenesis recalling 7,000 of its latest disposable bags custom designed to be used with the automated AXP device, used to process cord blood for stem cell separation.


WHAT'S THE PROBLEM?

Thermogenesis apparently failed to perform a quality control procedure on every shipment of the Auto-Xpress units from the time that the product first went on the market in 2006 up until now. The CEO, Willaim Osgood, who joined after the product went on the market, launched the recall after an internal audit found the flaw which was against the federal laws.

The flaw was the failure to perform quality control test for pyrogens (substances which cause fever, including bacterial toxins), which was omitted from the company's operating procedures.

This is one of my concerns in using any new products, as mentioned in my previous blog entry. It's always a real worry when products have problems and the service provider has to explain it to the clients. This is one of the reasons why we're evaluating if moving from a time trusted method to technology 1.0 is something that our clients would accept. Admittedly, cord blood stem cell clients need to be made aware of these concerns too.


WHAT'S BEING DONE ABOUT IT?

The CEO has admitted that "it was a mistake" on Thermogenesis's part and is now working with customers to retroactively test the Auto-XPress units, while the US FDA recommends that any cord blood units already stored be labeled as such so that they will be able to trace any problems if the unit is required for transplant.


According to the article:
There is currently no way to test whether a frozen cord blood sample is contaminated, according to the FDA recall notice. ThermoGenesis is in the process of validating a way to test for contaminants after a sample has been thawed.


While the AutoXpress sales accounts for 25% of Thermogenesis's USD 5.5 million revenue (making it the fastest growing product in the 22 year old company's history), its not the first problem with the bags due to the false-negative results in the first round which delayed shipments. This has depressed the company's share price (NASDAQ:KOOL) down by 6% to USD 1.53.

The AutoXpress bags are manufactured at an outsourced facility in Pennsylvania and the bags are tested at another outsourced facility.

GE Healthcare's Amersham division in Sweden signed an exclusive 15-year distribution deal with Thermogenesis to supply the AutoXpress system worldwide last October.

THE THERMOGENESIS REVENUE STREAM

The bulk of Thermogenesis's AutoXpress sales is currently from Cord Blood Registry (CBR) which collects and processes the majority of cord blood units in the US, though financial arrangements between them and Thermogenesis are not disclosed. The New York Cord Blood Bank also utilizes Thermogenesis's AutoXpress and I wonder how many units were used in public collections since June last year.

Thermogenesis predicts that first year revenue should be about USD 4 million with USD 50 million in total. Based on this number, between CBR, NYCBB and a smattering of other users around the world, approximately 35,000 to 40,000 AutoXpress units would have already been used for cord blood stem cell storage.


WHAT PROMPTED THE 143 MILLION KG BEEF RECALL?

The second news article was the US Beef recall that was sent to me via email... if you havent' already seen the nasty video and would like to see what prompted the recall, you can watch it here.

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.

Cord Blood Registry switches to CLOSED system cord blood stem cell processing

NO MORE VIALS FOR CBR? - ONWARD WITH THERMOGENESIS CRYO-SYSTEMS & SPECIALLY DESIGNED CRYOBAGS...!

I read with great interest that one of the world's largest and oldest cord blood stem cell banks, Cord Blood Registry (CBR) made an announcement on a 15-year contract with GE Healthcare (distributor) and Thermogenesis (manufacturer) to puchase disposables and utilize an auto expressor system to separate the stem cells. Presumably, this will also put CBR in line with AABB's new guidelines specifying that closed system processing and storage of stem cell units with "integrally attached segments" (ie the multi-compartment bag from Thermogenesis).


From the Thermogenesis website

Post FY2006

*In August 2006, GE Healthcare and Cord Blood Registry (CBR), the world's
largest family cord blood bank, announced a multi-year contract to supply
CBR with ThermoGenesis' AutoXpress cord blood processing system and
disposables and ThermoGenesis signed a Product Development and Supply
Assurance Agreement with CBR which assures the supply of AutoXpress
products for a 15-year period.


This no doubt is very profitable for Thermogenesis which according to their press release stands to gain more than 4 million USD in disposable revenue each year for the next 15 years from CBR alone.

We were approached by the company as StemLife has banked clients' stem cells in Thermogenesis cryo-bags since the beginning, but we have yet to evaluate the auto expressor system and its pricing for suitable application for the Malaysian and Thai market. Right now, our 24 hour lab service and passionately responsible laboratory team members ensure that all the strictest standards are adhered to, which we have proven through facilitating transplant requests.

When One Cord Blood Unit isn't Enough- Double Cord Blood Transplant

Congratulations to Dr. Peter McSweeney of Rocky Mountain Cancer Centre in Colarado for their successful double cord blood transplant for an adult! Sheila Gannon was pregnant when she was diagnosed with leukemia and chances of survival was only 20%. Given very few options due to the lack of a bone marrow match, her doctor obtained 2 units of umbilical cord blood stem cells in order to make up the necessary cell numbers.

From her video testimony (check it out on the right hand side of the page), she is doing well, apparently in remission and getting back to normal life. At least she is able to spend time with her newborn baby son now that she's had her treatment. It must have been tough on the family.

Stem cell bankers: if one unit isn't enough, then combination of cord blood units may be performed to make up the cell numbers. The main point is "the more cells the better".

I have yet to hear of someone saying that one bag of cord blood was too much and only a small portion of it was used for their therapy. To date, everyone uses everything they have in the bag.... and when one bag is not enough... add another bag of matching stem cells! In Malaysia, we have some rather unscrupulous people who tell others that by storing a unit of cord blood stem cells in 5 vials instead of in 1 bag, that it can be used 5 times, for your mum, dad, grandpa, aunty, uncle and yourself. This has yet to be proven true and until such time, remains a myth. Anyone promising this should be asked for a letter defining the exact promise.

StemLife attends Cord Blood Transplantation Conference in Biopolis, Singapore (1)

The StemLife team supported the organizers and attended the "Short course on Cord Blood Transplantation" meeting held today in Singapore's most prestigious research facility Biopolis (equivalent to the NIH for the lion city). Co-organized by Johns Hopkins, National University Hospital, Singapore Cord Blood Bank (SCBB) and the local Society of Haematology, it was quite a successful turnout of speakers and attendees who provided a lively audience.

Guest speakers today included Prof. Eliane Gluckman (1st cord blood stem cell transplanter), Prof. EJ Schpall (MD Anderson, FACT-Netcord accreditation), Prof. Takahashi of Tokyo University, Prof. CK Li from Prince of Wales Hospital Hong Kong, Prof. Ian McNeice, Johns Hopkins Singapore. Local speakers included Singapore's well known haem-oncologists Dr. Tan Ah Moy, Dr. Tan Poh Lin and Dr. William Hwang (now medical director of SCBB) and Dr. Michael Choi of Viacell Singapore.

Attendees included a collection of representatives of cord blood banks (largest stem cell company turnout from StemLife!), doctors from local hospitals and interested physicians and some students.

The seminars revolved largely around the results of cord blood stem cell transplantation since the first one performed by Prof. Gluckman, it is quite clear that the process of transplantation has been refined and improved tremendously. The data from her talk showed that unrelated donor cord blood stem cell transplants were as good as or better than proceeding with unmatched, unrelated bone marrow transplants. Nucleated cell number is still used as the transplant indicator as the correlation with CD34+ cells in cord blood was still tenuous, and the Gluckman recommendation was that at least 2x10e7 NC/Kg at infusion must be obtained for a greater chance of success in malignant diseases (StemLife derives its cut-off value from this recommendation). A member of a pharmaceutical group from India raised the question if she would use a unit which was contaminated with bacteria, given that it could be treated with antibiotics. Prof. Gluckman answered that she would not accept nor use the unit for fear of an adverse and unpredictable effect, which could lead to the death of the patient.

Also discussed were new protocols in cord blood transplantation using double bags of cord blood stem cells which should be as closely matched as possible and have shown promising results although the procedure still requires refinement. Prof. Gluckman's conclusion was that "cord blood is a unique resource for transplantation, regenerative medicine and scientific research, and for this purpose, there is an increasing need for the number of quality units stored".

Prof. EJ Schpall's talk centred largely on FACT-Netcord Accreditation, which is probably most applicable to the public banks who wish to trade their units internationally. She was quite clear on the fact that "public banks" around the world were in competition to "sell" the most number of units for transplantation (USD 21,000 per unit). A high barrier of entry is created through complying with standards and required protocols. She also stressed that FACT only accepts banks storing in cryobags and do not accept vials or any other form of storage.

This criteria would immediately eliminate banks storing their units in vials from participating in FACT accreditation or wishing to join Netcord in the future.