Cord-blood banker fights new rules

A company that stores umbilical cord blood for a price has asserted that people should have the right to preserve their biological materials for the future and questioned the Centre's new guidelines restricting commercial banking of biological materials.

By Our Special Correspondent
  • Published 15.10.17
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New Delhi, Oct. 14: A company that stores umbilical cord blood for a price has asserted that people should have the right to preserve their biological materials for the future and questioned the Centre's new guidelines restricting commercial banking of biological materials.

LifeCell, a Chennai-based company, said it "respectfully challenges" the guidelines released earlier this week by the Indian Council of Medical Research and the department of biotechnology that disallow the commercial banking of stem cells from all biological materials except umbilical cord blood.

Senior ICMR officials say the guidelines, which also restrict the commercial use of stem cell treatments to a limited set of health disorders, are intended to prevent consumers or patients from being lured into spending money on inadequately proven therapies.

The officials say they have long been concerned that companies have been urging consumers to invest in commercial banking of stem cells from cord tissue, menstrual blood, and other biological materials without evidence for therapeutic benefits. The guidelines approve the commercial use of stem cells only from umbilical cord blood for a limited range of conditions, mainly blood disorders, lymphomas and certain immune system disorders and recommend all other uses to be evaluated through clinical trials.

LifeCell says it is surprised at the restrictions on banking. "The decision to recommend a ban on banking of stem cells from cord tissue, menstrual blood, and other biological sources is unfortunate. Preserving cord tissue is a once-in-a-lifetime opportunity," said Mayur Abhaya, its chief executive officer in a news release.

However, Gita Jotwani, a senior scientist and a deputy director general at the ICMR said the research agency has long been concerned that commercial stem cell banking thrives on raising "hopes" among consumers of "prospects for treatments" that might never come true.

But the company says consumers should have the right to preserve stem cells from biological materials because advances in research and clinical trials involving stem cells currently underway in India and other countries could lead to treatments in the future.

"Banking is mere storage - not utilisation," the company said in a statement. "If utilisation was a concern, restrictions on the release of stored stem cells could easily have been prescribed, which has not even been considered," it added.

Since LifeCell began offering cord blood banking services in 2004, a company official said, it has preserved about 270,000 cord blood and tissue samples. "But we've retrieved only 46 for applications - each one of them for treatment of the conditions approved by the ICMR," the company official said.

The official said he will seek clarity about the implications of the ICMR-DBT guidelines from government's drug regulators. Neither ICMR nor DBT have regulatory authority which is vested with the Drug Controller General of India and medical councils.

The ICMR officials say the guidelines were motivated by concerns that sections of private doctors are offering stem cell treatments whose efficacy and safety has not been proven.

The websites of such clinics suggest that stem cells may be used to treat autism, osteoarthritis, liver cirrhosis, kidney damage, stroke among an array of other health disorders difficult to treat with conventional modern medicine.