South Africa grapples with “illegal” stem cell experiment scandal

dr-wian-standerSouth Africa is facing a stem cell scandal related to what a health policy news outlet called Spotlight there characterizes as illegal experiments by ReGenesis Biotechnologies, the company at the heart of the controversy. It had a contract with a governmental health provider agency, now apparently suspended.

The report begins this way: “The Medicines Control Council (MCC) this week suspended what appears to be unlawful stem cell experimentation at Pelonomi, a state hospital in Bloemfontein.”

However, there does not appear to be concrete data supporting safety and efficacy of the “treatments” in question. There were additional concerns over informed consent:

“MCC Chairperson Professor Helen Rees confirmed to Spotlight that inspectors had been to the Pelonomi site last Friday and again on Monday.

“Our concern was that the service level agreement made reference to medicines, injections and therapeutic research,” said Rees.

She said the informed consent documents referred to the patients giving permission for stem cell therapy, permission for stem cells to be removed, concentrated and re-injected and for their stem cells to be given to another person.”

The leader of the company was reported as Dr. Wian Stander.

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No radical life extension, says Nature paper, but Russian gets stem cell infusion to go for it

Any takers on the idea that we can get radical life extension through new technologies like stem cells, organ replacement, cybernetics, or genetic modification? Or just through healthier living in general?

A new Nature paper says there’s a natural limit on human lifespan around age 115 and getting past that is just not going to happen.


Jeanne Calment, who lived to be 122. Photo NY TImes/Getty

They don’t discuss (that I saw on a brief look) how new technologies could break this “rule”. Carl Zimmer has a nice NYT article on this development and on human aging more generally.

It also discusses the curious case of Jeanne Calment (pictured above) who lived to be 122, which the authors of the Nature paper would say was an extreme fluke.

It’s ironic that on the same day I saw all of this about limitations, I also noticed an article (via Google alert on stem cells) in the Russian newspaper Pravda about a scientist there who will get an infusion of stem cells to try to defy aging.

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Where does stem cell business Stemedica go from here after KPBS investigative report?

stemedicaFor quite a while there San Diego-based stem cell business Stemedica had a good run of publicity with reports of high-profile professional sports legends getting stem cells and the media reporting apparent good outcomes for stroke recovery, but more recent times have yielded some different publicity. An investigative report by KPBS reporter David Wagner raised some issues regarding the company. Here my take on Wagner’s report.

In his two-part piece (here and here), Wagner in part chronicled the story of stroke patient Jim Gass who ended up with a tumor on his spine after receiving several different stem cell interventions around the world over a period of years including one recently down in Tijuana administered by Dr. Cesar Amescua, who is not an employee of Stemedica.

According to Wagner’s report that last treatment involved two kinds of stem cells, one of which (adult stem cells) was reportedly manufactured by Stemedica. The other cells, fetal neural stem cells, were produced by Global Stem Cell Health. A Stemedica director was reportedly the one who referred Gass to the doctor down in Tijuana.

Many questions remain unanswered.

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4,000+ comments on FDA stem cell guidances, mostly clones of “My cells are my cells”

Keep your hands off of my cells!

At least, that is what many are telling the FDA regarding stem cells.

The FDA issued four draft guidances related to stem cells in the past year or so, held two public stem cell meetings, and now must decide what it is going to do with an out of control direct-to-consumer stem cell clinic industry. In part it will need to sort through all public comments from the meeting and those submitted online.


There are 4,251 comments on the online docket on the FDA stem cell guidances and commenting is now closed. As of a few weeks ago I think there were just something like 15 comments.

Commenters have been busy.

Is there anything to be learned from these comments?

For one thing, a quick look at the comments finds that many are essentially identical. In fact more than 700 use the exact same phrase “My cells are MY cells” and it looks like hundreds more comments have the exact same or similar language is used in more extensive forms. “My cells are my property”. “My cells are mine”. And so forth.

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Mitochondrial Replacement Techniques, the Mexican Case

cesar-palacios-gonzalezBy César Palacios-Gonzalez 

Earlier this week New Scientist broke the news that the first baby born after Maternal Spindle Transfer is already five months old, and even more, he seems to be doing well. Even when John Zhang’s team has achieved a world first, I agree with Dr. Alison Murdoch in that: “The translation of mitochondrial donation to a clinical procedure is not a race but a goal to be achieved with caution to ensure both safety and reproducibility”.

At the moment there is very little information regarding how all this went down, science wise, and for sure this instalment of the Scientific Congress of the American Society for Reproductive Medicine is going to be a really interesting one (I wonder if there will be any bioethicists around). A particularly salient feature of this news is that John Zhang’s team did not carry out the procedure in the US, but they went to México because, as Zhang is quoted saying, “there are no rules” in Mexico. I found such a quote really troubling, even if it was taken out of context, because amendments concerning assisted reproduction to the Mexican National Health Law are being discussed at the moment. As someone who works in the ethics of mitochondrial replacement techniques, and that was born and raised in Mexico, this whole story particularly worried me. The timing of the news could not have been worse for all those people in Mexico trying to get a scientifically informed and liberal amendment to the current National Health Law (yesterday I talked to some very distraught colleagues based in Mexico). It is surprising that this fact about the Mexican regulatory landscape was not taken into account by the New Scientist feature, and it is even more surprising that no news article or think piece has talked about it yet. Now, the amendment that at the moment seems to have the best chance of being approved is not only really conservative and discriminatory, as I have said here, but it is so poorly written that it interferes with other scientific areas. For example, it completely halts chimera research and human embryo research. The NIH moratorium on chimera research pales in comparison with this amendment. It truly seems as if it had been forged in the Vatican.

It is true that Zhang’s team did not break any laws, but it I think that, for practical purposes, there is an important difference between carrying out experimental techniques in places without regulations that are moving towards having them, and carrying them out in places with intentionally lax regulations. Why? Because making such a ‘stunt’ in a place where regulations are being discussed, and where there is no public debate regarding the technique employed, can have an adverse effect in assisted reproduction as a whole. For example, the technique used by Zhang’s team has already been wrongly portrayed in the media and this has fuelled anti-ARTs sentiment. You would be appalled by the inaccuracies and mistakes in Mexican news reporting on this issue (although it must be said that there have also been inaccuracies and mistakes in how it has been reported in the US and UK). It is as if the whole Dolly the sheep PR meltdown did not teach us anything. For the time being, Mexico fits in the category of “country moving towards having ARTs regulation”, and in a couple of days I will be able to tell you if there will be no more ‘three person babies’ in Mexico for a considerable time.

Finally, I also think that it is problematic that there has been an erasure of the woman who donated the egg from most, if not all, the news and think pieces. While it has been said once and again that the intending mother egg’s maternal spindle was rehoused in a healthy enucleated egg, nothing has been said about the donor. It is appalling to see that there has been no mention of just how important she was for this procedure to occur. In addition to this, we do not know if she donated the egg in Mexico, or if the donation took place in the US. Even when Zhang’s team has stated that they had IRB approval, it is important to remember that there are serious ethical questions that arise from egg donation that need to be answered (which I suppose will be answered at the conference?). Specially when all this is carried out in place where there are no specific regulations in place.

César Palacios-Gonzalez is a Research Associate at the Centre of Medical Law and Ethics, The Dickson Poon School of Law, King’s College London.

You can find more on the ethics of mitochondrial replacement techniques here: