Scientific community calls for more stringent regulation of basic stem cell research and clinical trials
The scientific community in the country has called for more stringent regulation of basic stem cell research and clinical trials, while adding that the hype surrounding stem cells exceeds the hope they offer.
Stem cells are endowed with the ability of self-renewal and pluripotency (the ability to differentiate to any cell type), properties that have brought them to the forefront of clinical research. Clinicians hope to devise cures for several life-threatening conditions like spinal cord and brain injuries, heart disease and Parkinson’s using the cells. Currently bone marrow transplantation is the only stem cell therapy that has successfully been used. Concerns have been raised from time to time on unethical use of stem cells in clinical trials.
Speaking at a public consultation on guidelines on stem cell research and therapy held by Indian Council of Medical Research’s department of biotechnology (ICMR-DBT), A N Bhisey, co-chairman, National Apex Committee Stem Cell Research and Therapy, says, “There were certain loopholes in the guidelines released in 2007 and the apex committee has kickstarted the process of revising them.”
Talking about revisions, Shyam Agarwal, former director of Tata Memorial Centre, Navi Mumbai and chairperson of the drafting committee, says there will be a new chapter in the revised guidelines addressing the challenges presented by stem cell clinical trials. “Stem cell clinical trials are different from routine trials because the intervention is a biological product,” he adds.
Experts also raised concern about private clinics offering cure for spinal cord injuries, Alzheimer’s and other conditions through unproven stem cell therapies. However, Agarwal says that ICMR-DBT guidelines only apply to basic research and clinical trials. Regulating the activities of private clinics is the job of Medical Council of India, he adds.
Manorama Bhargava, chairperson haematology at Sir Ganga Ram Hospital, New Delhi, notes the guidelines for basic research and clinical trials need to be more protocol based. “You lay out a set of, say, 20 protocols that have to be inviolably followed by all scientists and clinicians. If you do not meet even one of the protocols, you should not be allowed to go ahead with the research.”
On whether the government would pass any law on stem cell research, V M Katoch, director general of ICMR, says, “By 2012, an act on stem cell research on human subjects could become a reality.”
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