The decision, a part of the National Guidelines for Stem Cell Research, 2017, aims to check exploitation and commoditization of resources
New Delhi: The government on Wednesday put a temporary ban on commercial banking of stem cells derived from biological materials such as cord tissue, placenta, tooth extract and menstrual blood, in the absence of scientific evidence about its benefits.
The decision, a part of the National Guidelines for Stem Cell Research, 2017, aims to check exploitation and commoditization of resources.
“At present, there is no scientific evidence to substantiate clinical benefits with the use of stem cells derived from the cord tissue, placenta, tooth extract, adipose tissue, dental pulp, menstrual blood and olfactory ensheathing cells, etc. Yet, procurement and banking of these biological materials is increasingly becoming a commercial activity," the guidelines said.
“As of now, only umbilical cord blood (UCB) banking is permitted and licensed by the Central Drugs Standard Control Organization (CDSCO). Accordingly, commercial banking of all other biological materials (except UCB) is not permitted until further notification," the guidelines added.
The guidelines, prepared by the Indian Council of Medical Research (ICMR) under the health ministry, have also tightened rules for private UCB banks issuing misdealing advertisements.
UCB is considered a rich source of CD34 (a protein), hematopoietic (cells that give rise to all the other blood cells) and mesenchymal (cells that can differentiate into a variety of cell types such as bone cells, cartilage cells, muscle cells and fat cells) stem cells.
Use of UCB-derived hematopoietic stem cells (HSCs) for treatment of various blood-related and immunological disorders is currently well established, particularly where a human leukocyte antigen (HLA, proteins that are responsible for the regulation of the immune system in humans) matched sibling is not available.
“We have updated the guidelines with current advances in the field," said Dr Soumya Swaminathan, secretary, department of health research,and director general at ICMR.
The guidelines also highlighted the need for more public UCB banks.
“There is a paucity of public-funded UCB banks in India. On the other hand, several private banks have come up that engage themselves in promotional advertisements offering storage of cord blood with the promise of future therapeutic use. Such advertisements are often misleading for the public and lack comprehensive and accurate information," the guidelines stated.
The storage of cord blood can only be of use in certain conditions.
“ Private storage of the cord blood HSCs is advisable when there is an elder child in the family with a condition treatable with these cells, and the mother is expecting the next baby. In other situations, the parents should be educated about the limitations of banking at this point of time," the guidelines stated.
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