28 February,2011 06:37 AM IST | | Priyanka Vora
Indian Council of Medical Research warns patients of trials marketed as therapies, says research is still in experimental stage and urges volunteers to exhibit caution
The 'magical remedy' promised in the name of unproven stem cell therapies has now drawn the attention of the International Society for Stem Cell Research (ISSCR).
The Boston-based body is irked by the profusion of commercialised stem cell treatments advertised on the world wide web, and the way these trials are being marketed as 'therapies' to patients desperate for a cure.
The ISSCR has published a report 'Patients Beware: Commercialised Stem Cell Treatments on the Web' warning patients to be cautious before undergoing any such treatment.
And, following its cue, the Indian Council of Medical Research (ICMR) has come down heavily on the marketing of such unsubstantiated therapies in vogue these days.
The ICMR's Assistant Director General (stem cell research), Dr Geeta Jotwani, said, "Our guidelines clearly state that other than bone marrow transplantation, all other stem cell-induced treatments are in their clinical trial phase and cannot be considered as proven treatment.
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Patients should understand that the treatment itself is in the experimental phase. If any clinician is offering an unproven treatment, he is indulging in an unethical practice." But, ICMR, a nodal body under the Union Health Ministry, is not a regulatory body and thus cannot take any action.
Cost free
Nevertheless, the civic-run Sion Hospital the only public hospital in the country offering stem cell therapy for neurological problems like multiple dystrophy recently stopped the research after ICMR stated that it does not have an approval for the clinical trials.
The ICMR had also objected to the fees the hospital charges from patients for treatments that are still in an experimental stage (see box).
Following the rebuke, the facility had stopped stem cell treatment for a brief period. But it is scheduled to restart it in two weeks.
Dr Alok Sharma, head of the neurosurgery department, Sion hospital, tells us why.
"The ICMR guidelines state that the institute doing stem cell research should register with the ICMR's National Apex Committee. But, at present it does not exist.
Thus the rules are difficult to implement," he said.
He justified the costs, saying, "Being a civic hospital, we are already working to give the therapy completely free as part of the research project. Earlier as well, the patients were required to spend only on tests and chemicals which were not available at the hospital."
However Dr Jotwani said that the apex body has been constituted, it is functional, and all clinicians offering stem cell therapies must register themselves with it. She added that the research has potential but offering it to the masses as treatment at this nascent stage could be disastrous.
Cord blood bank
One of the ramifications of the growing popularity of stem cell-induced clinical therapies has been a boost to cord blood blanking. Such banks store umbilical cord blood for future use, so that families may retrieve stem cells from them later to treat diseases of the blood and immune systems.
Industry experts say that the country's cord blood banking industry has seen a phenomenal growth by nearly 50 per cent in the last one year.
But Dr Jotwani cautions against private banking of cord blood, "It is not compulsory that stem cells retrieved from cord blood will be useful for the treatment being promised. Instead, we would endorse public cord blood banking.u00a0
The female should donate cord blood and the stem cells can be retrieved for any patient who needs it, that is if it matches with the patient." Much like how blood banks work
However, Rajesh Sharma, managing director of Bangalore-based Cryo-Save India, a multinational stem cell bank, said that increasing awareness and affordability are driving couples to opt for cod blood banking.
"We always inform the couple that stem cell therapies are relatively new. Still, around 3,000 clinical trials are in progress which indicates that there is hope." Cryo-Save has about 1,50,000 stem cell samples from across the globe. Two to three per cent of these have been contributed by India.
In the city
Meanwhile, Mumbai-based Reelabs, involved in both cord blood banking and stem cell therapy, receives at least 100-150 samples of cord blood a month.
Its director, Dr Abhijit Bopardikar, said, "We started banking only after establishing the efficacy of stem cell therapy. We know that the treatments are in the experimental stage and we inform the same to the patients. All treatments we provide have received a nod from the ethics committee."
30,000
No of Indians that opt for cord blood banking every year. Currently, five major banks are operational in India
Celebrities too
According to Rajesh Sharma of cord blood bank Cryo-Save India, popularity and affordability of cord blood banking are inducing couples to go for it.
The cost of cord blood banking for 21 years is around Rs 75,000 to Rs 1 lakh, which is affordable to the middle class, he said.
Other than that, celebrity couples opting for stem cell banking have made cord blood banking even more popular among others.
What to ask
If a patient wants to undergo a stem cell therapy, they should first ask the clinician whether the stem cell therapy being offered is a clinical trial which means it is experimental in nature and whether it is registered with ICMR's National Apex Committee.
According to the ICMR guidelines, the patient does not have to pay a single penny for undergoing such a clinical trial as they are volunteering for an unproven therapy.
