From now on, any use of stem cell in patients will be considered research, and not therapy, according to fresh national guidelines.
Stem cell use in patients must be done only within the purview of an approved and monitored clinical trial with intent to advance science and medicine.
“In accordance with this stringent definition, every use of stem cells in patients outside an approved clinical trial shall be considered a malpractice. It is hoped that this clear definition will serve to curb the malpractice of stem cell ‘therapy’ being offered as a new tool for curing untreatable diseases,” according to the Indian Council of Medical Research and the Department of Biotechnology.
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The decision to drop the word ‘therapy’ has been taken on the recommendation of a joint drafting committee of the ICMR and the Department to emphasise the fact that stem cells are still not part of standard care.
Hence, there can be no guidelines for therapy until efficacy is proven. These guidelines, issued on Saturday, are intended to cover only stem cell research, both basic and translational, and not therapy. Any stem cell use in patients other than for haematopoietic (producer of red, white blood cells and platelets) stem cell reconstitution for approved indications is investigational at present.
The revised guidelines are aimed at checking exploitation of patients by some clinicians by offering stem cell treatment even though it is still an emerging field of regenerative medicine. There is no conclusive proof of safety or therapeutic efficacy of stem cells in any condition yet.
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Use of stem cell holds promise for improving health by restoring the function of cells and organs damaged due to degeneration or injury. Stem cell biology has potential application in several areas of biomedical research including drug development, toxicity testing, developmental biology, disease modelling, and tissue engineering. But like many innovations, stem cell research also involves scientific, ethical and social issues.
Commodification of human cells and tissues
Apart from the challenges of using appropriate stem cells for a particular condition, there are important issues related to use of embryos for creating human embryonic stem (hES) cell lines.
As these may lead to commoditisation of human tissues and cells, there is an inherent risk of exploitation of individuals, particularly the underprivileged, as also the contentious issue of human germline engineering and reproductive cloning.