ICMR guideline spurs debate on regulation of stem cell banking

ICMR seeks to prevent commercialisation of unproven stem cell therapies; industry says move is detrimental as it will impede research in this sphere

The Indian Council of Medical Research (ICMR) guideline on stem cell research has spurred the stem cell banking industry to discuss the need for regulations and guidelines on the storage of stem cells other than umbilical cord blood (UCB) cells. Currently, stem cell in general do not have substantial clinical benefits, but could be useful in future.

Major industry players in the segment say that at present there is lack of clarity about the collection and storage of these stem cells, which could be misused by some companies.

The National Guidelines for Stem Cell Research (NGSCR), 2017, which seeks to ensure standards on various processes related to Stemcell treatment, has been prepared with the aim of preventing commercialisation of unproven stem cell therapies and generating new knowledge, based on sound scientific rationale while addressing all ethical concerns, says the ICMR.

The document details that at present there is no scientific evidence to substantiate clinical benefits with the use of stem cells derived from cord tissue, placenta, tooth extract, adipose tissue, dental pulp, menstrual blood and olfactory ensheating cells. Yet their procurement and banking is increasingly becoming a commercial activity and care needs to be taken so that there is no exploitation and commoditisation of the resources.

"As of now, only UCB banking is permitted and licensed by CDSCO (Central Drug Standard Control Organisation). Accordingly, commercial banking of all other biological material is not permitted until further notification," it said.

Mayur Abhaya, president, Association of Stem Cell Banks of India (ASBI) and CEO of LifeCell, the largest umbilical cord stem cell bank today has questioned the guideline, saying that the observation will have consequences in the longer term. This is because the preservation of biological material would be beneficial since there are hundreds of research works taking place across the globe on various sources of stem cell and at least some of them may be proved successful. Once that happens these samples could be used by the customers for treatment.

He added that the CDSCO has already granted approval for the commercialse Stempeucel, a mesenchymal stem cell derived from bone marrow for treatment, to Stempeutics Research (a group company of Manipal Education and Medical Group, and a joint venture with Cipla). In this case, the observation is inconsistent with the decision of the CDSCO, he said. The industry is seeking clarification with the CDSCO officials on its stand on the observation.

At present, the companies are preserving some of the stem cell samples, apart from the UCB stem cell. These are preserved by attaining no objection certificate from the drug control authority, which is regulating the stem cell segment. While the guideline may not directly impact the industry at present, it could have a bearing on the decisions by the drug control authority which is the approving authority for stem cell products, he said.

C V Nerikar, chief executive of Cryoviva Biotech Pvt Ltd, another player in the segment, said that the company would like to get some clarity on the remarks of ICMR. He said that the company is stopping collection of materials other than Umbilical Cord Blood stem cell and would look forward for approval. He said that so far there has been no guideline related to preservation of other biological materials.

Satyen Sanghavi, of another stem cell baking firm BabyCell said that the ICMR's obervation is appreciable, since it would be helpful in curbing the malpractices in the industry and support the genuine players in the field. He said that proper regulation related to banking of stem cells from sources other than Umbilical Cord Blood Stem Cells are in place, it would help the industry to grow better. India was the pioneer in commencing storage of other stem cells also, he added.