The Indian Council of Medical Research (ICMR) has made recommendations in its national guidelines for stem cell research (2017) and is looking at suspending commercial banking of stem cells derived from biological materials such as cord tissue, placenta, tooth extract and menstrual blood. In its recommendation, ICMR has stated that there is no scientific evidence to substantiate the clinical benefits of these stem cells.
Accordingly, the ICMR has issued guidelines stating that commercial banking of all biological materials, other than umbilical cord blood, is not permitted until further notification.
Mr Mayur Abhaya, CEO and managing director of Life Cell, an umbilical cord stem cell bank, has questioned the decision of ICMR in this guideline recommendations for preserving vital stem cells from cord tissue, menstrual blood and other biological material without considering many aspects.
‘Inconsistent decision’
Calling it an inconsistent decision he said: “We are seeking a rationale to this guideline. Recently, Stempeutics Research (a group company of Manipal Education & Medical Group and a Joint Venture with Cipla Group) had received approval to commercialise its product “Stempeucel” — a cultured adult allogeneic mesenchymal stem cells derived from bone marrow for treatment. The product was approved for treating Critical Limb Ischemia due to Buerger’s disease. Hence this ban is inconsistent to this approval issued by Drug Controller General of India.”
In a release issued by the group they have noted that ICMR is disregarding global practices.
“Preservation of cord tissue and other sources of stem cells have been prevalent across the globe considering its research advancements in medicine. Advanced economies like US and Europe have been encouraging support towards licensing / registration of such banking practices. Even internationally acclaimed regulatory bodies such as USFDA, AABB have acknowledged and accredited cord tissue banking, whereas in India these guidelines throw a surprise, having the impact of curtailing the future potential of stem cell treatments,’’ noted the release.
Mr. Abhaya added that the decision to recommend a ban on banking of stem cells from cord tissue, menstrual blood and other biological sources is very unfortunate and totally overlooks the potential contribution of stem cells in research and development.
