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Stem cells are cells that have the potential to develop into some or many different cell types in the body, depending on whether they are multipotent or pluripotent. Serving as a sort of repair system, they can theoretically divide without limit to replenish other cells for as long as the person or animal is still alive. When a stem cell divides, each "daughter" cell has the potential to either remain a stem cell or become another type of cell with a more specialized function, such as a muscle cell, a red blood cell, or a brain cell.
Stem cell therapy is the use of stem cells to treat certain diseases. Stem cells are obtained from the patient’s own blood bone marrow, fat and umbilical cord tissue or blood. They are progenitor cells that lead to creation of new cells and are thus called as generative cells as well.
Stem cell therapy in India:
Currently the only scientifically approved stem cell therapy in India is the use of hematopoietic stem cells employed to treat various haematological, immunological and metabolic disorders, mainly related to blood. Hematopoietic stem cell transplantation uses stem cells derived from bone marrow, peripheral blood or umbilical cord blood and is proven to treat leukemia, lymphoma, plasma cell disorders, solid tumours like germ cell tumour and a select non-malignant conditions such as Thalassemia Major. All the other stem cell therapies being promised in India for conditions such as cerebral palsy, autism, diabetes, paralysis, Parkinson’s Disease, mental retardation, etc., are unproven and without scientific basis. These experiments fall in the realm of research which need to be regulated in the interest of patient safety.
Draft National Guidelines for Stem Cell Research 2017:
The ICMR has drafted “Draft National Guidelines for Stem Cell Research 2017” in collaboration with the Department of Biotechnology under the Ministry of Science. The guidelines not only revise the last set issued in 2013 to incorporate fresh research in the area, these also enlist, for the first time, disease conditions proven to be treated by stem cells. These conditions don’t include neurological and regenerative therapies, infertility, autism, neuro-muscular disorders and other conditions many private players in the country promise to unsuspecting patients. The guidelines have been brought with the purpose of curbing unethical therapeutic use of stem cells in India. The guidelines clarify that so far stem cells are only known to treat hematological (blood-related) disorders. Anything else anyone is promising is unproven and falls in the category of clinical trial research for which the investigator must take approvals from the apex drug regulator of India, the Drug Controller General of India.
Why stem cell research needs regulation?
Hordes of private labs have made a business of stem cell research. Pregnant women are pre-booked with cord blood banks which promise to store for years blood from baby’s umbilical cord and placenta right after birth and promise treatment of even genetic disorders when needed. Prospective parents are paying lakhs for an exercise which has no scientific basis. ICMR experts have also clarified that doctors conducting stem cell research cannot cross specialties, must be trained in Good Clinical Practices and must show MCI registrations. Strangely, ICMR does not know the number of stem cell research centres in India despite mass proliferation. ICMR’s National Apex Committee for Stem Cell Research has been reviewing claims in the market on stem cell therapies for conditions known to be incurable. Stakeholders say the new guidelines, which lack the force of law, won’t help unless India’s drug regulator strictly enforces research protocols and Medical Council of India starts penalising defaulting doctors. ICMR started publishing stem cell research guidelines in 2007. The last came in 2013.
By: Dr. Vivek Rana ProfileResourcesReport error
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