Cord Blood Banking in the UK: Status and Directions of the RCOG

Its been a hectic week at StemLife and I apologise for not having updated the blog for a while. A few friends and family members kindly updated me with emails about the recent announcement by the Royal College of Obstetricians and Gynaecologists (RCOG) on cord blood banking.

Firstly, I'd like to clarify the role and function of the RCOG. Most relevant is that the RCOG sets the exams that all aspiring gynaecologists have to pass in order to practice. If you check out their website, its tagline is "Setting standards to improve women's health". Clearly, the focus of the College is on women and one of their roles is also to "reduce maternal and neonatal mortality and morbidity", i.e. to assess the risks involved in any gynaecological or obstetric procedures for both the mother and the doctor involved.

It was in this capacity that the College issued a recent statement reflecting the same sentiment that they had back in 2001- that they supported cord blood banking if for altruistic reasons- that is for donation and public use. From the statement made by the head of Department of Women's Health at King's College London and Chair of the RCOG expert group, Professor Peter Braude said that they "had a huge amount of commercial companies offering cord blood storage to parents and medical practitioners wanted guidance on the validity of some of the advertising claims".

I checked out the number of companies offering this service in the UK and found that there are now 7 (acknowledgements to Dr. Frances Verter's wonderful site) which is a significant number for 595,000 or so births per year. I can imagine that the clinics must get very crowded with brochures all claiming to be the better bank. There has also probably been some confusion amongst the doctors, nurses and hospital staff when parents come in requesting a collection from cord blood bank a,b or c.

However, the biggest problem that I forsee is not so much that parents might come in with different kits, but rather for the three following reasons:

1) Most deliveries requesting cord blood are at NHS (government) hospitals where doctors are on rotation duty (leading to point 2)

2) The doctors delivering the babies are not necessarily the same as those seeing the patient in the clinic (which doctor gives consent to collect?)

3) Most doctors are not trained to collect cord blood for this purpose and may not always be successful (whom does the client/patient hold responsible?)

Clearly, these pertinent issues warrant the intervention of the RCOG due to the potential risk taken by the doctor in collecting the cord blood when the doctor may not know what to do and that he/she has to do it. It is the slight confusion that happens which can result in really bad taste for both patient, hospital and doctor. Therefore, to protect the reputation of the doctors and lessen the paper procedures (which are already a big hassle for the hospital staff), the RCOG has taken the stand that cord blood should be donated to the NHS, and that if NHS hospitals choose to permit cord blood collection, they have to draw up their own guidelines on what charges there should be and who bears the liability. I think that a fair payment made to the hospital and doctor for successful procedures would be acceptable to the requesting client (full refund if unsuccessful for the avoidance of doubt on anyone's part).


A MIS-INTERPRETATION

Unlike what has been proclaimed on the headlines of news articles(BBC, Times), the RCOG is not against cord blood banking but rather prefers that in its NHS hospitals, cord blood is donated for the public's immediate use- instead of banking it for a possible future use.

One of the messages that the RCOG then helps to advertise is that the NHS provides banking of donated cord blood at the following hospitals, where staff are available to assist and ensure that its done right.

I found the list of hospitals from this site and here's an extract:

NHS cord blood banks centres currently collecting donor cord bloods in UK

Although antenatal patients may offer to donate for unrelated transplantation, the option of altruistic cord blood banking for the National Blood Service banks is, for logistic reasons, currently undertaken only at the following hospitals: Northwick Park Hospital in Harrow, Barnet General Hospital, The Luton and Dunstable Hospital, and the Mater Infirmorum Hospital in Belfast.


Is collecting cord blood as dangerous as the RCOG articles proclaim?

StemLife Malaysia has already successfully banked more than 6000 units of cord blood with the assistance of doctors and nurses with the mutual understanding that cord blood collection can only take place if it is safe and does not alter the process of birth by the mother nor affect the baby's aftercare. I'm not sure about the UK, but having worked with private hospitals in Malaysia, care of the mother and the baby is always the doctor's first priority. Cord blood is collected in utero to ensure that the blood is collected without clots and only as much as the umbilical cord is able to yield. Furthermore, doctors also respect the patient's wishes and knows that they may play a part in the welfare of the child subsequently in life (StemLife has a story about this, but I'll tell you about it at a later date).

Additionally, I checked out the College of Paediatrics website too to see what the role of its doctors are supposed to play. I found that one of the roles would involve the education of the public about the potential use of cord blood stem cells in the child's life.

Duties of a paediatrician:

Paediatricians, whatever their specialty interest, should understand their particular responsibilities for the holistic and life-long health of children who come under their care: each contact is an opportunity for health promotion and disease prevention.

Paediatricians should be aware of current medical and political affairs affecting the lives and health of children.

We have supportive paediatricians here and I'm delighted to say that they are increasingly aware that stem cells could play a role in helping siblings and the child itself should it take ill with a condition treatable with stem cells.


You can read the actual message from the RCOG here, but bear in mind that it takes into account the fact that the NHS is already an overburdened government healthcare institution. In the appeal for funding for the NHS cord blood bank, if the potential use of cord blood stem cells is as small and insignificant as they say, why bother putting anymore money into something which might never be used?


The NHS has had structural and economic issues* for a while and we should not find it surprising that if you try to overlay a private service (like cord blood banking) on top of a public-funded healthcare system, there will undoubtedly be tensions as to what services are on offer at public hospitals and, at what cost to the system.

*UK Health Secretary Patrcia Hewitt has announced earlier this month that the NHS's overall deficit is GBP 512 million (approx. RM 3.4 billion).

Do not misinterpret NHS Trust Doctor's stance on Cord Blood Collection

A quick search on cord blood reveals a number of articles citing a senior consultant obstetrician, Dr. Leroy Edozien, commenting on cord blood collection. I felt that the headlines proclaiming that he was totally against cord blood collection is unfairly represented by the press, as his actual comments relate mostly to the cord blood collected in public hospitals and its logistic issues poses to the doctors.

My analysis of the comments that I could find are as follows:


His concern: "Time spent on collecting cord blood is time away from the care of this mother, the baby, and, critically, other patients."

This may be true in government facilities as staff numbers are sometimes limited and due to the overwhelming load of patient deliveries, doctors and nurses often have to manage multiple ladies in various stages of labor. However, the time spent also does depend on the method of cord blood collection. Some companies provide syringes (cheaper) and expect the doctor to load the anti-coagulant prior to collection. However, StemLife makes this as easy as possible for one doctor/ nurse to perform the collection with sterile, pre-loaded blood bags with anti-coagulant which saves time and manipulation.


He adds: ""As well as being given a realistic assessment of the value of cord blood banking, parents need to know how their care, and the care of other women, can be affected by cord blood collection and what could go wrong during collection. There could also be risks that the cord blood could be contaminated or mislabeled, which could lead to legal action."

True, except that all cord blood stem cell banks should have already signed agreements with parents and counselled them sufficiently to understand that the collection of cord blood is never guaranteed. Some mothers may have emergency deliveries where it may be deemed that cord blood cannot be safely collected. Dr. Edozien's specialty is managing mothers with pregnancy problems and if these ladies requested cord blood collections, this may have bearings on the delivery process.

And not only do cord blood volumes vary from baby to baby (think small, large, long, short umbilical cords) but also despite thorough cleaning of the cord by the doctor, a single bacteria which may remain on the cord may enter the blood bag and contaminate the unit. This is not the doctor's fault nor the cord blood banks' as bacteria exist naturally everywhere, in the mucosa, vaginal tract and also in the digestive tract. All it would take would be a small amount of urine, poo or fart* to get the bacteria onto the cord and perhaps into the blood.

Cord blood banks do not usually accept contaminated units in accordance with good banking practices (StemLife does not, although I understand that there are some in asia who do...) and will discard them after informing the parents of the result. In this event, StemLife provides a full refund to the client and this happens in a small number of collections each month. I suppose if there was no refund involved, then not only would the client have lost the opportunity to bank the stem cell unit but also some money (the sum which is involved in the processing and testing of the unit).

Dr. Edozien also poses the concern of mislabelling but StemLife addresses this issue in 2 ways: 1) pre-labelling the cord blood kit with the mother's name prior to the birth of the baby and 2) ensuring that our collection team member checks on the name of the mother against our delivering database. I'm curious as to how the UK cord blood banks manage this point.


He says: "Even if the rapid pace of technological advancement results in today's speculation becoming tomorrow's reality, risk management, medicolegal, ethical, and public policy considerations militate against commercial collection of cord blood in NHS maternity units. It should therefore be NHS policy not to facilitate umbilical cord blood collection by its staff."

-If I had a child with thalassemia major and my next baby's cord blood could help treat the condition, would you prevent me from collecting the cord blood?
Can you guarantee a matching unit for my child in the public cord blood bank?-
....Its pretty tragic if no exceptions can be made in the NHS hospitals as there may be mothers who really require the service although they may not necessarily know it at the birth of their child. Private cord blood stem cell banks have already facilitated transplants for these patients and the numbers continue to grow.


He admits:"Increasing numbers of women in maternity units across the United Kingdom are requesting collection of umbilical cord blood at delivery to enable storage of stem cells for possible autologous transfusion in the future."

There is no denying that many mothers will come to know about cord blood stem cells. UK Mothers who wish to have cord blood stem cells collected may need to go to private centers. That would be a pity as it would be a step back from making another simple procedure routinely available for all mothers. I'm no expert on the NHS policies and I'm sure the doctors are doing the best they can under the circumstances available, but perhaps they could consider having those mothers who wish to have their cord blood collected check in to specific rooms and pay a small procedural fee to have a doctor, nurse or trained cord blood bank staff perform the collection. This may also provide some financial alleviation on the healthcare budget of the hospital.



*please excuse my use of this colloquialism

Stem Cell News Updates- Hearts & Virgin & Astronauts...

I came back into the office this morning sporting a new flu bug and trying not to speak to anyone for fear that it might spread. Two bottles of anti-tussive Robitussin (manufactured locally by pharmaceutical manufacturer Pharmaniaga) and a whole tube of fizzy Redoxon later, the fever has fortunately been reduced to phlegmy obstruction in my eustachian tubes, nose and throat.

I have full confidence that my stem cells are kicking into overdrive to produce the necessary lymphocytes and leukocytes to do battle, as evidenced by the phlegm (cellular war debris and aftermath). :)


BATTLE AGAINST BREATHLESSNESS & PAIN

Anyway, I had a quick look at the recent news in the stem cell arena and saw another update on the Gary Schaer trial at Rush Medical Center's Cardiac Catheterization Lab using CD34+ cells for heart disease, where the objective is to "stimulate the growth of new blood vessels to bring more blood and oxygen to the heart muscle, so that these patients will have a better quality of life and less chest pain". One of the reasons why I highlight this clinical application is because one of the big brand names, Baxter, is helping to bring together two specialties- cardiology and hematology. No longer are CD34+ a code language for hematologists to use alone, but these cells have been perhaps overlooked or underestimated in their capacity to regenerate. Their results have been like ours, which is good news to reinforce our work- the treatment is well tolerated and patients report having less chest pain and improved exercise capacity.

Many doctors I speak with are afraid of cross specialties, largely because to properly understand it requires an extensive undertaking in time to read up on one's own, or to have to fork out a decent amount of time (+ money) to receive further training in the area. I understand the reluctance and agree somewhat that these are special interest areas and think that it should probably be left up to those who are keenly interested or have been specifically trained so that it can administered safely and ethically.

Having said that, I also believe that it is possible that doctors who are interested in this subject area but neither have the time nor money to pursue it as a specific interest area, are able to garner the expertise through collaborating with a specialist organization like StemLife. Unlike other companies who found the business attractive and believed they could replicate our work after reading our prospectus, it does take more than cash to ensure committment, energy and drive to fuel passion and continuous knowledge assimilation.


MONEY MAKES THE WORLD GO ROUND?

Whilst we're on the topic of spending wads of cash, I also read about Sir Richard Branson's very PR-driven announcement of initiating a cord blood stem cell bank in the UK. From the BBC news site:

Virgin says its service is unique because it will offer a charitable element, allowing the NHS to use some of stem cells the company stores. Sir Richard explained: "We will take an individual's cord blood and we will divide it in two. "So, part of it will go into a national blood centre that anybody can get access to. And the other half will be put aside for the child." He said this should help particularly high risk ethnic groups who are prone to conditions that can be treated with stem cells but who may have difficulty finding well-matched cord blood.

I found this to be interesting on the ownership and ethical prospect. The idea is marvellous, semi-altruistic (except for the fact that parents still have to pay a fee) but leaves behind quite a number of questions in my mind which I wonder how they will resolve. Here's a few ones that spring immediately to mind:

Parents have to pay 1500 British Pounds or (RM 10,500) to store their stem cells in Virgin's bank.

1. So if it is divided in 2, who owns which half and does the parent have the first right of refusal if someone needs it but they wish not to donate?
2. How will they ensure that the cord blood collected will be sufficient to be divided in half? (volumes are highly variable)
3. Does the NHS have to pay Virgin for the use of the stem cells?
4. With this new company, will the NHS now permit Virgin to collect the cord blood in their trust hospitals or will be specific ones only? (see previous blogs)
5. If the unit is half used and the donor now needs it, can they get a replacement for free?

According to the Virgin press release on this topic, Professor Colin McGuckin and his Newcastle team are involved with Sir Richard on this project and are his advisors. If the cord blood stem cells can also be used for research, it would guarantee their facility an endless supply of cells to work with for stem cell expansion or treatment. I'm not against entrpreneurs wishing to start up stem cell banks, but I do think that if new models are being thought up, I'm keen to know how they are being thought through.

Okay, this is turning out to be a rather long blog entry so bear with me for the last bit which I feel brings everything round and round and round.


STEM CELLS & SPACE TRAVEL: CORD BLOOD INTO A NEW DIMENSION



It turns out that this article mentioned that Prof. Colin McGuckin (yes, him again) has been awarded a USD 1 million grant to determine the potential of growing new body tissues to replace tissue damaged or turned cancerous by space radiation, using his zero-gravity simulator. He plans to put adult stem cells derived from astronaut's blood in a zero-gravity bio-reactor and using a cocktail of stimuli (ie cytokines), instruct the cells to grow into liver or muscle or any other tissue. The aim being to provide NASA with the means for a replacement body part for every astronaut on their travel to another planet (maybe Mars in 2030 or Uranus in 2090?).

This is exciting because it negates the effect of time on the wear and tear of the body. If you are a Star trek fan (and I'm talking The Next Generation here), you'll remember that cool wand that Dr. Beverly Crusher uses whenever one of the crew is injured to stimulate healing in a total of 5 seconds. Must be a stem cell activation factor.

And there weren't too many lives that she couldn't save :)

Surgeons Using Stem Cells for Bone Fractures

I was intrigued when I saw this article, not so much by the actual announcement of the stem cell work performed, but rather exactly where the location of the hospital was and I was surprised that hospitals outside the major cities of England were also conducting stem cell therapeutic trials.

Oswestry, I found out is a small town in the county of Shropshire, off Shrewsbury on route to the Cambrian mountains near Wales. The Robert Jones and Agnes Hunt Orthopaedic Hospital in Oswestry does look like an excellent hospital and has a website which is very detailed. It is clear from the description of the hospital's history that pioneering new techniques and investing in research is a priority, so stem cell clinical application is certainly on their checklist.

The consultant surgeons there have been conducting clinical trials using stem cells obtained from patient's own bone marrow (autologous) to heal bone fractures which could not be successfully healed with conventional techniques using metal pins and plates. According to the report, the research trial plans to take in forty patients. Fifteen patients have since undergone the treatment and 8 out of the first 10 patients followed up are successfully healed (able to drive and return to work).

The procedure:
Surgeons harvest the stem cells from the patient's pelvic bone and multiply the stem cells for a period of 3 weeks.

Consultant surgeon Professor James Richardson said: "Things have worked out quite well. A few patients have needed other procedures, refixation for instance, but the important thing is they're healing."
Surgeons collect the stem cells in a sample of bone marrow, usually from the patient's pelvis. They are purified and then multiplied in a sterile laboratory. 3 weeks later, the surgeons have to re-expose the fracture and place the stem cells at the site. After a few months, the bone appears to regain the strength of its original structure. One of the patients, Sarah Humphreys was one of the first patients to be treated with stem cells and is now able to walk unaided.

She said: "I'm absolutely fine, the leg doesn't give me any problems at all apart from a bit of residual pain if I've been for a long walk, or been a bit more active than I would have been, but not to the extremes it was. I'm basically doing everything I was prior to the accident."

The surgeons aim to treat 40 patients in the clinical trial and due to the autologous nature of the cells, there are no chances of rejection. They are unsure as to how the stem cells transplants work (nature does in deed work in mysterious ways) but speculate that the cells may turn into bone and seal the gap, or play a role in the secretion of chemicals that kick-start the healing process.

The article states: These are experimental treatments for now. But surgeons say the results so far are so promising that stem cells are likely to be widely used on the NHS in a matter of years.


Editor's Note:
I am particularly enthused by these results as StemLife has also been obtaining positive results from patients who have had stem cells in combination with their orthopaedic procedure. We have also been working with a niche and focussed orthopaedic hospital- the Kuala Lumpur Sports Medicine Center. If you have a cartilage injury that you'd like to discuss and explore stem cells may help in its healing, please give us a call.