Cord blood banking - should you, or shouldn't you?

There was some recent publicity (see here and here) about this issue, provoked by a comment made by Dr Irving Weissman on this issue. As the Director of the Institute of Stem Cell Biology and Regenerative Medicine at Stanford University, his comments are taken seriously. He was quoted as saying that parents were being fleeced by stem cell bankers, and likened them to fraudsters.

The International Society for Stem Cell Research (ISSCR) of which Dr Weissman is also head, was quick to point out that his comments referred to the sale of stem cell therapies rather than the banking of stem cells.

Nevertheless the issue of cord blood banking needs to be clarified.

Cord blood blanking promises to store cells from the cord blood of babies, with a hope that these cells can be used in the treatment of various diseases later on. The idea is that these cells have some potential to differentiate into various mature cells. However it is not usually pointed out that this potential is limited and that these cells cannot form organs or tissues, and cannot replicate adequately to populate an adult body.

It should also be recognized that cord blood cells are banked in two possible ways, as part of a public bank, where the cells can be used by anyone with the appropriate need, or as a private bank where only the donor uses the cells. This latter form of transplant is called an autologous transplant.

While the former has considerable merit, because kids with various diseases can potentially benefit by tapping into this bank, the latter autologous bank has very little to offer.

There are relatively few proven indications for autologous transplants using cord blood, as compared to the heterologous use of cord blood. Furthermore the chance that a child will be able to use his own stored cord blood is very small.

The American Academy of Paediatrics (AAP) produced a policy statement on this issue in 2007. Their position hasn't changed since then. In the document they say: "Because there are no scientific data at the present time to support autologous cord blood banking and given the difficulty of making an accurate estimate of the need for autologous transplantation and the ready availability of allogeneic transplantation, private storage of cord blood as “biological insurance” should be discouraged."

Singapore has a public cord blood bank, called simply the Singapore Cord Blood Bank. They are doing good work and should be supported.

There are two private cord blood banks, Stemcord and Cordlife.

Their claims are that the cord blood can be used to treat an extremely wide range of diseases. Read their claims for yourself : for Stemcord, and for Cordlife.

Read the above for yourself, and take into consideration the AAP's policy statement: "Cord blood donation should be discouraged when cord blood stored in a bank is to be directed for later personal or family use, because most conditions that might be helped by cord blood stem cells already exist in the infant’s cord blood (ie, premalignant changes in stem cells). Physicians should be aware of the unsubstantiated claims of private cord blood banks made to future parents that promise to insure infants or family members against serious illnesses in the future by use of the stem cells contained in cord blood. Although not standard of care, directed cord blood banking should be encouraged when there is knowledge of a full sibling in the family with a medical condition (malignant or genetic) that could potentially benefit from cord blood transplantation."

One wonders why the Ministry of Health and the Singapore Medical Council does not come down firmer on these unsubstantiated claims by private cord banks.

What??? No regulation for stem cell products also? !!!

Today's Straits Times carried a special report on stem cell treatments. But it totally misses the point that stem cell treatments are a poorly regulated area in Singapore.

I remain horrified that we insist on regulating drugs to the nth level. Preclinical studies, clinical trials.... and what not. Pretty much about 10 years of generating data on safety and efficacy before we allow them into the market place. But when it comes to cell based products, whether of animal or human origins, there is this huge blindfold on. The Bioethics Advisory Committee is only concerned about the ethics of doing such research. But if it is for clinical use, there are no regulations in place, and it's pretty much a hands off approach.

I am particularly surprised that when the Health Products Acts was passed in 2007, it only applied to First Schedule items such as Medical Devices and Cosmetics. Wasn't it considered then that cell based products were something to be concerned about? Or for that matter, any biological products that were not technically 'medicines'.

Oh yes, we can argue that such experimental practices fall under the scrutiny of the Singapore Medical Council, who have a Ethical Code and Ethical Guidelines to hit people on the head with. Para 4.1.4 particularly. But this is too ambiguous and subjective to have any real meaning. I mean, what are unproven therapies? If I have 20 anecdotal reports, does that mean it is proven? How about 50? 5000? or 5?

So why aren't cell-based products registrable? Where are the legislative powers for HSA to do this work? Why is there such a big blindspot in our regulatory environment?

No regulation of xenotransplantation in Singapore?

Martin Huang's administration of sheep foetal cells for rejuvenation, is technically classified as a form of xenotransplantation.

Other types of xenotransplants would be - sticking an animal (e.g.pig) organ (heart, liver, kidney etc) into a human recipient, or putting animal (again usually pig) cells into people (e.g. pancreatic islet cells).

Strangely xenotransplants seem to be a relatively unregulated medical procedure. The HSA regulates medicines, complementary medicines, cosmetics and medical devices but apparently not animal cells. It would seem that xenotransplants would be regulated under transplantation laws, but not so. The Human Organ Transplant Act doesn't cover animal cells into humans, just the use of human organs.

So doctors seems to be pretty unregulated with respect to their sticking animal bits and pieces into people. Possibly it may be considered an experimental surgical technique, but one could argue that sticking sheep fetal cells into someone isn't really surgery. It could possibly be regarded as an experimental procedure or a clinical trial; in which case it should be approved by the ethics committee. But this would assume the doctor would classify it as an experiment. If he maintains that the procedure is not experimental he need not subject it to ethics review.

It then becomes the responsibility of the Singapore Medical Council to consider it under Para 4.1.4 of the ethical guidelines. Unproven therapies. And that seems to be pretty inconsistently interpreted at the moment.

It would seem that Singapore is quite backward and confused where this is concerned.

Here is a list of site where you can read about regulations elsewhere:
http://www.biosafety.be/GT/Regulatory/Guidelines_CTXeno.html

Why was animal cell therapy allowed to be imported for use?

The Martin Huang saga has created quite a bit of consternation in the public as well as the medical profession. Even the Director of Medical Services was prompted to come public with a reprimand of sorts. Many people thought the poor sod had gotten off with little more than a mere slap on the risk. Which was true. A fine of a mere $5000. Loose change for this guy.

But the question must also be raised as to what actual law did he break, and what crime did he commit? Apparently he done the unconscionable and had injected sheep foetal cells into patients to slow aging. The Medical Council screamed that this was offering unproven therapy, and not allowed. Such unproven therapy violate the SMC Code of Ethics :

The SMC Ethical Code and Ethical Guidelines para 4.1.4 state very explicitly: "A doctor shall treat patients according to generally accepted methods and use only licensed drugs for appropriate indications. A doctor shall not offer to patients, management plans or remedies that are not generally accepted by the profession, except in the context of a formal and approved clinical trial."

What Martin Huang did was offering a therapy that was uproven, and which was not part of a formal clinical trial. Bad guy.

But then again ( and I have posted on this conundrum before) so many of our doctors are clearly in breach of this. Unproven therapies? All off label use of medications are unproven therapies. Furthermore, their use are often not in the context of a formal clinical trial. How about off-label stent operations? The recent media reports on inappropriate slimming pill prescriptions fall into this category of offense. Yet the SMC did not act.

Not that I am a supporter of Martin Huang. I totally disagree with what he did and fully support the SMC's actions in his case, but the SMC's actions now look horrendously inconsistent. How did the SMC arrive at the conclusion that the offering of sheep fetal cells was so wrong compared to surgeons sticking all kinds of un-trialed appliances into our bodies, and physicians offering all kinds on drugs for un-trialed and unproven indications?

I wonder.

One last bit of ranting before I go for my teh-see....

Were the sheep cells licensed to be imported for cosmetic therapy? Here is where HSA has to explain their position. There apear to be regulations for medicines, for biosimilar products, for some medical devices and for cosmetics (external applications)..... but for cell based therapies?? Silence.

So were the cells allowed into Singapore for such use. If they were licensed imports, would this license represent tacit approval by HSA for their use? If they were not licensed, was Martin Huang guilty of breaking an import law? If so, he should be hit with the full weight of the law, as would any merchant intending to trade in an illegal product. Or does this indicate there is a legal loop hole for doctors to violate patients' safety? If so, why is there such a loophole and what are we doing about it?

What are the conflicts of interests within HSA, as they themselves begin to offer cell based therapies? How do they regulate themselves, in the absence of proper legislation for this, and as they come into competition with commercial providers of cell-based therapies?

We need to know.

Stem-Cell challenge for the Singapore Medical Council

I was offline for a while for various reasons, and came back today to this curious flurry of reports in My Paper (1, 2 , 3 & 4) about the use of 'stem cells' for the treatment of aging and heart failure (many thanks to Ms Dawn Tay!!). The reports refer to two clinics, one in Parkway's Mt Elizabeth (TheraVitae), and the other in Paragon Medical Centre (Clinique Suisse). Clinique Suisse's Dr YM Wong, incidentally was also featured in a previous blog-post about another whacko scheme.

I must admit I don't know too much about these fancy therapies but a number of bizarre and confused things pop up in the reports:

a] The inconsistent picture of whether these were offered as part of a clinical trial. Both Dr Wong himself and Dr Eugene Sim of Parkway, offerred that these were not part of clinical trials, yet Dr Sim said that these were approved by the Parkway ethics board and the HSA (which would only happen if they were formal trials).

b] These therapies are 'unproven' and are not currently acceptable methods of treatment. Dr YM Wong was quoted as saying:
"We don't talk about clinical trials. We're not reducing people to digits and statistics. We treat people as a whole. I don't think like most doctors do. I'm different. Singapore doctors don't believe that stem cells can be used to delay ageing. They're very conservative and feel that stem cells should be used only in leukaemia and other incurable diseases."

c] Most importantly, the offering of unproven therapies is strictly deemed unethical. Para 4.1.4 of the SMC Ethical Code and Ethical Guidelines state very explicitly: "A doctor shall treat patients according to generally accepted methods and use only licensed drugs for appropriate indications. A doctor shall not offer to patients, management plans or remedies that are not generally accepted by the profession, except in the context of a formal and approved clinical trial."

MOH and HSA was quick to point out that doctors who flout these guidelines are liable for disciplinary action. (The SMC was however, strangely silent.)

But what was really disturbing was that this was going on for about 10 years.

So here is what I believe is an important and very timely challenge for the Singapore Medical Council, especially in the wake of recent discussions about her ability to 'self-regulate'. Did she know about the offering of unaccepted therapies? Or did she conveniently blind herself to the violations and clung obstinately to the mantra that she cannot act unless someone complained officially?

Time for a serious re-boot of the system?