Experts call for improved oversight to combat rise of unproven stem cell therapies

Three stem cell therapy experts are calling for the World Health Organization (WHO) to establish an advisory committee on regenerative medicine to tackle the promotion and marketing of unproven stem cell therapies and provide guidance for countries around the world. All three authors are Lawrence Goldstein Science Policy Fellows for the International Society for Stem Cell Research (ISSCR) and ex-officio members of ISSCR’s Public Policy Committee.

According to the authors of the perspective published in Stem Cell Reports, the WHO should establish an expert advisory committee to address the spread of unproven stem cell treatments, as it has done with its committee to develop global standards for governance and oversight of human genome editing. Such a committee, they said, could promote greater harmonisation among regulatory standards, convince member nations to prioritise this issue on their public health agendas and develop educational and outreach tools that could help increase awareness among physicians and patients on the danger of this practice.

“The field of regenerative medicine, which entails the manipulation of cells and tissues to obtain therapeutic properties, has been hailed as the most promising research field in modern medicine,” stated the perspective’s senior author, Mohamed Abou-el-Enein, the executive director of the joint University of Southern California/Children’s Hospital of Los Angeles Cell Therapy Program, US. “Starting in the early 2000s, however, unregulated stem cell clinics offering untested and poorly characterised treatments with insufficient information on their safety and efficacy began emerging all over the world, taking advantage of the media hype around stem cells and patients’ hope and desperation.”

First author, Zubin Master, an associate professor of biomedical ethics at the Mayo Clinic, added: “…even though we have had significant advancement in the field of regenerative medicine, more needs to be done to ensure the safe and timely delivery of evidence-based interventions to patients, many of whom have exhausted all available options.” He continued: “Many patients with chronic diseases who desire a regenerative medicine option have exhausted conventional medicine treatments and have no other suitable option. We should aim to develop pathways to provide patients with evidenced-based experimental regenerative intervention as possible options where there is oversight, especially in circumstances where there is no suitable alternative left.”

The perspective by Abou-el-Enein, Master and Kirstin RW Matthews, Baker Institute for Public Policy Center for Health and Biosciences at Rice University, US, was apparently written after they realised from their work at the ISSCR that most efforts in this space have focused on the marketing practices of providers and clinics, with much less emphasis on the tightening of regulations and enforcement to deal with the issue from a global standpoint.

The commentary highlights several proposals, including the harmonisation of regulatory definitions surrounding stem cell and regenerative medicine and the importance of balancing the scientific evidence demonstrating safety and efficacy of stem cell and regenerative products with the needs of the patient.

Abou-el-Enein commented: “I believe that the global spread of unproven stem cell therapies reflects critical gaps in the international system for responding to health crises, which could put the life of thousands of patients in danger. Urgent measures are needed to enhance the global regulatory capacity to detect and respond to this eminent crisis rapidly.”

The authors also suggest that an active surveillance mechanism should be established to collect and analyse information on clinics delivering unproven stem cell therapies and share it with the public to increase awareness, as well as taking the appropriate legal actions. They noted that educational programs for patients and physicians on the realistic potential of stem cells and the regulatory pathways that are in place for developing them are extremely important in combatting the issue.x