South 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.
The cost was more than $2,000 USD per treatment and the article says there would have been a guarantee of 1,000 patients/year, which is odd considering that the therapy in question is experimental and it seems hard to imagine that there could be a guarantee of a certain number of patients consenting to be experimented upon.
This situation in South Africa resonates with ongoing for-profit, stem cell human experiments ongoing in the US and elsewhere that raise troubling questions.
Note that there are quite a number of stem cell/regenerative medicine businesses and products that also using the name ReGenesis or versions of this so keep in mind that this story does not apply to them.