Stem cell therapy guidelines on cardsJune 29, 2018
Health ministry proposes to amend D&C Rules for regulating stem cell products
India may soon bring guidelines for using stem cell products for therapeutic purposes.
India is among several countries where research is being conducted into the use of regenerating stem cells for treating various debilitating and degenerative disorders such as Parkinson’s, multiple sclerosis and other neurological conditions. Stem cells’ ability to differentiate into specialized cells is also being tested for treating heart disease, liver ailments, spinal cord damage and cancer.
However, treatments using stem cells is not without its dangers. Balancing therapeutic benefits with potential risks presents a challenge in a complex area like stem cell therapy. This was also one of reasons for bringing tighter regulations for stem cell therapy in the western countries.
India is yet to come up with regulatory guidelines for treatments utilizing stem cells. The Drugs and Cosmetics Rules, 1945–the rule book for pharmaceutical products in India–does not mention stem cell-based therapies. However, the Indian Council for Medical Research and the Department of Biotechnology last year issued a set of norms on conducting stem cell research.
The Union health ministry is now considering an amendment to the D&C Rules to streamline the regulatory framework for advanced research in this rapidly growing field.
The ministry has already held discussions on this subject with the Drugs Technical Advisory Board (DTAB), a body set up under the health ministry to offer guidance to the government on pharmaceutical products.
The proposal is to add a clause for stem cell-based products (SCBP) to the D & C Rules.
The draft of the proposal defines SCBP as “a drug which has been derived from processed cells including cell or tissue which has been processed by means of substantial or more than minimal manipulation with the objective of propagation and/or differentiation of a cell or tissue, cell activation, and production of a cell-line, which includes pharmaceutical or chemical or enzymatic treatment, altering a biological characteristic, combining with a non-cellular component, manipulation by genetic engineering including gene editing and gene modification”.
The term ‘substantial or more than minimal manipulation’ is further elaborated as “ex-vivo alteration in the cell population — including T-Cell depletion and cancer cell depletion — and expansion which is expected to result in alteration of function”.
Clearly, stem cells derived products will be termed as drugs. This means that the regulatory trajectory followed by drug products would be applicable to stem cell drugs as well and they have to go by the protocols mandated for any drug development.
Minimal manipulation procedures include the isolation of tissue, washing, centrifugation, suspension in acceptable medium, cutting, grinding, shaping, overnight culturing without biological and chemical treatment, disintegration of tissue, separation of cells, isolation of a specific cell, treatment with antibiotics, sterilisation by washing or gamma irradiation, freezing and thawing.
Human cells or tissues removed from an individual for implantation into the same individual during the same surgical procedure should not undergo processing steps beyond rinsing, cleaning or sizing and these steps shall not be considered as processing, according to the new clause.
Experts in the field laud India’s decision to regulate stem cell research as a step in the right direction. It could help rein in clinics mushrooming across the country claiming to cure many diseases which currently have no known cure.
Stem cell implant for AMD?
Researchers led by the University of Southern California’s Roski Eye Institute developed a retinal implant from embryonic stem cells to help improve visual functioning in people with advanced dry AMD or age related macular degeneration.
The implant is made by attaching stem cells to a nonbiodegradable, synthetic material that is similar in structure and function to Bruch’s membrane, a layer of the eye adjacent to the retinal pigment epithelium (RPE).
RPE breaks down as dry AMD progresses. The implant will mimic the function of RPE.
The researchers placed the implant into the eyes of four people with vision loss from dry AMD. Over the course of several months, they observed that one patient was able to read more letters on an eye chart after the procedure, and two exhibited improvements in their ability to use the area of the retina that had been treated.
The researchers reported that none of the four patients in the USC study experienced side effects from the implant.
“Our study shows that this unique stem cell–based retinal implant thus far is well-tolerated, and preliminary results suggest it may help people with advanced dry age-related macular degeneration,” said co-author Mark Humayun, M. D., Ph.D., director of the USC Institute for Biomedical Therapeutics and the lead inventor of the implant.