By Anso Thom and Marcus Low
The Medicines Control Council (MCC) this week suspended what appears to be unlawful stem cell experimentation at Pelonomi, a state hospital in Bloemfontein. At the same time the Free State Department of Health has cancelled its contract with the stem cell company, ReGenesis Biotechnologies following a list of questions sent by Spotlight in connection with the involvement of controversial Health MEC Dr Benny Malakoane.
Until a week ago the Free State department of Health was set to spend tens of millions of Rands on unproven and potentially dangerous stem cell therapies for the treatment of musco-skeletetal diseases in its orthopaedic knee patients at two hospitals. The treatment was run by a private company called ReGenesis Biotechnologies and has started on June 1.
A service level contract (seen by Spotlight) between the Free State Department of Health and ReGenesis Biotechnologies indicated that the service would be provided in Pelonomi hospital in Bloemfontein and Boitumelo hospital in Kroonstad. The department would pay R30 000 per client, with a guaranteed supply of one thousand patients per year. This adds up to R30-million per year and R90-million over the three years of the contract.
Spotlight sent the MEC’s office a number of questions over a week ago. We delayed going to print as Malakoane’s spokesperson Mondli Mvambi requested that he be given time to investigate. On Thursday this week Mvambi sent an email stating the following: “Our response to all your questions is that after careful consideration, the Free State Department of Health has decided to cancel the ReGenesis Biotechnologies contract with immediate effect. We will not comment any further on this contract as it is now sub judice.”
Mvambi would not explain why the case was now sub judice.
Questions Spotlight sent to ReGenesis went unanswered, despite an initial request from ReGenesis CEO and the doctor carrying out the procedure Wian Stander that the questions be e-mailed to “Chevonne”. Stander is also listed as the “Owner and Integrative Medical Practitioner” of the Slimming Clinic in Bryanston. According to the website of the Slimming Clinic he has done talks on Holistic Medicine and Healthy Ageing in South Africa over the past few years.
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.”
“This is not a proven therapy and we were concerned about the reference to research as well as the fact that stem cells will be given to other persons. This led to questions whether this was in fact a clinical trial and if it was, the MCC has not given permission for it to be conducted,” said Rees, adding that their first priority was the safety of patients. Medical research that has not been approved by the MCC is unlawful in South Africa.
“We have asked Dr Stander to stop enrolling patients and now await a response to the information we have requested from him,” Rees said. She said that “injecting anything into a patient comes with risk as you always run the risk of introducing infection.
The contract seen by Spotlight states that ReGenesis “shall provide the department with the clinical governance and treatment protocols at the onset of the service on 1 June 2016.”
The contract also states that the Free State Department of Health and ReGenesis would establish a project management committee consisting of the MEC of Health as Chairperson as well as the CEOs of Pelonomi and Boitumelo hospitals, COOs and representatives from ReGenesis. It reveals that the committee shall meet monthly for the duration of the Agreement to “track progress, resolve pertinent matters to the effective and seamless treatment of patients”.
The contract states that this agreement would run until 30 June 2019 with the department in essence guaranteeing 1 000 patients per annum, paying ReGenesis R30 000 for each treatment. There is provision in the contract for ReGenesis to motivate for treatment in excess R30 000. The contract also stipulates an upfront payment of a percentage of the cost of the three year contract, which also makes provision for a price increase after the first year. The Department also undertakes in the contract to supply ReGenesis with all consumables required.
A source close to the MCC investigation confirmed that they have been unable to find evidence of a tender. However, Carte Blanche claimed last that a tender had been published in April seeking a service provider who can provide “cell based stem cell regenerative medicine and therapeutic research services”. Head of Department Dr David Motau confirmed to Carte Blanche that the contract had been cancelled.
Stem cell therapy for knee problems
Substantial research is being done around the world into various stem cell therapies including for the treatment of arthritis and osteoarthritis of the knee. A search of the literature however shows no evidence from phase III trials indicating that any form of stem cell therapy is safe and effective for the treatment of knee problems. With few exceptions, medical treatments are only approved for use in humans once compelling evidence is available from phase III trials.
In the case of stem cell therapies caution is particularly important given some reported cases of tumour formation associated with such treatments. In a recent letter in the New England Journal of Medicine doctors warn against the risks associated with unproven stem cell treatments. Outlining a specific case, they write: “This case and others in which tumors have developed in the context of stem-cell tourism (a trend in which patients travel for the purpose of obtaining therapy) illustrate an extremely serious complication of introducing proliferating stem cells into patients.”
The United States Food and Drug Administration has warned consumers against using unregistered stem cell therapies. They have also sent warning letters to companies providing certain kinds of stem cell therapies and in 2012 won a court case against the company Regenerative Sciences in which the court affirmed the FDA’s authority to regulate stem cell therapies making use of a patient’s own cells.
Spotlight will continue to run a series of articles on this investigation www.spotlightnsp.co.za