Promotion and commercialization of unproven stem cell therapies is a global problem that requires a global solution, say experts in a perspective published on June 8 in the journal Stem cell reports. The authors of the article call on the World Health Organization (WHO) to establish an advisory committee on regenerative medicine to tackle this problem and provide advice to countries around the world.
“The field of regenerative medicine, which involves the manipulation of cells and tissues to achieve therapeutic properties, has been hailed as the most promising area of research in modern medicine,” said lead author Mohamed Abou-el. -Enein, executive director of the association. University of Southern California / Los Angeles Children’s Hospital Cell Therapy Program. “From the early 2000s, however, unregulated stem cell clinics offering untested and poorly characterized treatments with insufficient information on their safety and efficacy began to emerge all over the world, taking advantage of the hype around it. stem cells and the hope and despair of patients. “
“Advancing regenerative medicine is essential to tackle the burden of chronic disease, which WHO considers a major international priority,” says first author Zubin Master, associate professor of biomedical ethics at the Mayo Clinic. “And while we have had significant advancements in regenerative medicine, much remains to be done to ensure the safe and timely delivery of evidence-based interventions to patients, many of whom have exhausted all available options. “
The three authors of the commentary are Lawrence Goldstein Science Policy Fellows for the International Stem Cell Research Society (ISSCR) and ex-officio members of the ISSRC Public Policy Committee. They decided to write it after realizing that the majority of the effort in this space has focused on the marketing practices of providers and clinics, with much less emphasis on tightening regulations and enforcing them to treat. the problem from a global perspective.
The commentary highlights several proposals, including the harmonization of regulatory definitions surrounding stem cells and regenerative medicine and the importance of balancing scientific evidence demonstrating the safety and efficacy of stem cells and regenerative products with patient needs.
“Many chronic disease patients who want a regenerative medicine option have exhausted conventional medicine treatments and have no other suitable option,” said Master. “We should aim to develop pathways to provide patients with an experimental, evidence-based regenerative intervention as possible options when there is monitoring, especially in circumstances where there is no longer a suitable alternative. . “
The authors write that the WHO, which has already established an expert advisory committee to develop global standards for governance and oversight of human genome editing, could create a similar committee to fight the spread of treatments. by unproven stem cells. They say the committee could promote greater harmonization between regulatory standards, convince member countries to prioritize this issue in their public health programs, and develop educational and awareness tools that could help raise awareness among physicians and physicians. patients at the risk of this practice.
“I believe the global spread of unproven stem cell therapies reflects critical gaps in the international system for responding to health crises, which could put the lives of thousands of patients at risk,” said Abou-el-Enein . “Urgent action is needed to strengthen global regulatory capacity to detect and respond quickly to this looming crisis.”
The authors also propose the establishment of an active surveillance mechanism to collect and analyze information on questionable clinics performing these procedures and share it with the public to increase awareness, as well as take appropriate legal action. They note the importance of educational programs for patients and physicians about the realistic potential of stem cells and the regulatory pathways that are in place to develop these promising therapies.
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