Editorial: Regulating stem cell therapy

A revised set of guidelines on stem cell research was recently released by the Indian Council of Medical Research and the Department of Biotechnology, seven years after an earlier one was issued. Despite claiming that the revision was necessitated by a need to “reflect new scientific and clinical findings” that have changed the landscape of stem cell research being undertaken in the country and its possible translation, there is a glaring omission that reflects a lack of application of the mind. The guidelines make it abundantly clear that any use of stem cells in patients except to treat various haematological, immunological and metabolic disorders using haematopoietic stem cells should, by default, be considered as clinical trials. The exemption is on the grounds that the use of haematopoietic stem cells to treat the said disorders has been “established as a standard of medical care.” Of course, the use of bone marrow (containing haematopoietic stem cells) to treat diseases like leukaemia has been in vogue in India since the 1960s. But what has been overlooked in the new guidelines is that treating damaged corneas by limbal transplantation for limbal stem cell deficiency should also be considered as an established method of care; limbal stem cells are transplanted from the healthy eye to the damaged eye of the same patient to treat an affected cornea. No other alternative method is currently available to treat such cases. For the last few years, a handful of tertiary eye hospitals in India have been treating such cases using limbus stem cells; since 2001, one institute alone has treated nearly 1,000 patients. Though the use of limbus stem cells is not as old as haematopoietic stem cells, about 1,500 patients with corneal damage have been treated so far; there is also sufficient evidence to prove its safety. Hence, there is a compelling reason for the ICMR and the DBT to apply the same yardstick and correct the anomaly.

Though belated, the decision to call all the untested “therapies” offered to gullible people as clinical trials is indeed commendable. This would end the rampant exploitation of patients by some doctors. Many untested and unproven stem cell treatments are being offered as a magic bullet for many types of diseases and conditions. Similarly, several untested techniques to separate, grow and expand specific stem cells are available in the country. Besides failing to produce the promised benefits, there is a real possibility of causing greater harm to patients when stem cells are manipulated in the laboratory. But with many clinics and hospitals already offering stem sell therapy for a wide variety of conditions, it remains to be seen how swiftly they can be regulated under the new guidelines.

Published in The Hindu on March 12, 2014