ICMR okays 30 diseases for stem cell treatment
Last Updated IST
At present there is no scientific evidence to substantiate clinical benefits with the use of stem cells. Representational Image
Indian Council of Medical Research has approved the much-hyped stem-cell treatment for 30 odd categories of diseases – mostly cancer – making it clear that other treatment claims by the healthcare agencies are to be considered with a pinch of salt.
At present, there are no approved indications for stem cell therapy other than the specific therapies for certain conditions, ICMR said in its new guidelines for stem cell research, released earlier this week.
The apex medical research agency listed 20 types of indications (diseases) for adults and another 13 categories of indications for children below 18 years, where stem cell treatment are permitted. Besides cancers, some complicated congenital diseases are on that list.
Every other therapeutic use of stem cells shall be treated as investigational and conducted only in the form of a clinical trial after obtaining necessary regulatory approvals, says the guideline.
If such cure is provided as treatment, that would be considered unethical and has to be prohibited, it noted.
The stern warning comes at a time when several doctors and healthcare industry offers stem cell treatment to unsuspecting patients without going through the rigours of the regulatory approval and clinical trial.
A medical researcher founding success with a possible stem cell therapy has to write to the ICMR director general with all the trial data so that the council can decide whether such a claim is tenable.
The apex medical research council asked the government to end banking of stem cell derived from sources like cord tissue, placenta, tooth extract, adipose tissue, dental pulp and menstrual blood.
At present there is no scientific evidence to substantiate clinical benefits with the use of stem cells. Yet, procurement and banking of these biological is increasingly becoming a commercial activity. Hence, care needs to be taken so that there is no exploitation and commoditization of the resources,” says the ICMR document.
However, a Chennai-based company that does stem cell banking opposed the ICMR recommendations arguing they were against global best practices and not in sync with a decision taken by the Drugs Controller General of India.
“We challenges ICMR’s recommendation to suspend commercial banking of stem cells from cord tissue, menstrual blood and few other biological materials,” said Mayur Abhaya, chief executive officer and managing director of LifeCell - India’s largest umbilical cord stem cell bank.
“It is important to preserve these stem cells considering that it is a once-in-a-lifetime opportunity and would stay protected when they turn into potential treatment opportunities. It is imperative that the government should impose a strict ban on the usage of these cells for treatments and ensure compliance but not restrict preservation for the future,” he said.
ICMR also released two separate guidelines on the use of adults and children in the clinical trial.
At present, there are no approved indications for stem cell therapy other than the specific therapies for certain conditions, ICMR said in its new guidelines for stem cell research, released earlier this week.
The apex medical research agency listed 20 types of indications (diseases) for adults and another 13 categories of indications for children below 18 years, where stem cell treatment are permitted. Besides cancers, some complicated congenital diseases are on that list.
Every other therapeutic use of stem cells shall be treated as investigational and conducted only in the form of a clinical trial after obtaining necessary regulatory approvals, says the guideline.
If such cure is provided as treatment, that would be considered unethical and has to be prohibited, it noted.
The stern warning comes at a time when several doctors and healthcare industry offers stem cell treatment to unsuspecting patients without going through the rigours of the regulatory approval and clinical trial.
A medical researcher founding success with a possible stem cell therapy has to write to the ICMR director general with all the trial data so that the council can decide whether such a claim is tenable.
The apex medical research council asked the government to end banking of stem cell derived from sources like cord tissue, placenta, tooth extract, adipose tissue, dental pulp and menstrual blood.
At present there is no scientific evidence to substantiate clinical benefits with the use of stem cells. Yet, procurement and banking of these biological is increasingly becoming a commercial activity. Hence, care needs to be taken so that there is no exploitation and commoditization of the resources,” says the ICMR document.
However, a Chennai-based company that does stem cell banking opposed the ICMR recommendations arguing they were against global best practices and not in sync with a decision taken by the Drugs Controller General of India.
“We challenges ICMR’s recommendation to suspend commercial banking of stem cells from cord tissue, menstrual blood and few other biological materials,” said Mayur Abhaya, chief executive officer and managing director of LifeCell - India’s largest umbilical cord stem cell bank.
“It is important to preserve these stem cells considering that it is a once-in-a-lifetime opportunity and would stay protected when they turn into potential treatment opportunities. It is imperative that the government should impose a strict ban on the usage of these cells for treatments and ensure compliance but not restrict preservation for the future,” he said.
ICMR also released two separate guidelines on the use of adults and children in the clinical trial.