doi:10.1038/nindia.2014.39 Published online 25 March 2014
Samir Padhiyar, a 20-year-old choreographer, was paralysed waist down due to spinal injury in a road accident in 2011. A hospital in Ahmedabad promised him absolute cure through stem cell therapy.
"I was told I could walk as before with just three stem cell injections at 3-6 months interval. I signed the consent form and paid them Rupees 800,000 (about $13000)," he says. "But there was no follow-up during the whole treatment that lasted for a year and there has been absolutely no change in my health condition even after two years. When I complained and asked for refund, they offered another stem cell treatment at a lower cost which I refused."
India's revised stem cell guidelines announced recently aim to protect hapless patients like Padhiyar from being exploited by doctors offering unproven stem cell treatments. "Such fraudulent practices need to be stopped urgently, while ensuring that scientifically designed and responsible research on stem cells is not hindered," according to the guidelines prepared jointly by the Department of Biotechnology (DBT) and the Indian Council of Medical Research (ICMR).
Under the new rule, stem cells cannot be offered to patients as 'therapy'. They can be used only in "clinical trials" after approval from the Drugs Controller General of India (DCGI). The only exception is use of haematopoietic (blood forming) stem cells for treating blood disorders, which DBT secretary Krishnaswamy VijayRaghavan calls "a proven therapy." For other cell therapies to be considered proven, they "should not only be safe but also have unequivocal data on efficacy."
Almost simultaneously, the DCGI, which regulates all use of stem cells, has announced that it will modify rule-21 of the Drugs and Cosmetics Act to include "stem cell and cell-based products" as new drugs. This means anyone offering stem cells for treatment can do so only after conducting clinical trial and getting a licence from DCGI .
Polani Seshagiri, in charge of the stem cell laboratory at Indian Institute of Science in Bangalore, says the steps taken are a sincere effort to enforce a ban on the clinical use of stem-cell treatments which don't have adequate safety and efficacy data.
Predictably, the move has upset companies currently using stem cells derived from bone marrow, umbilical cord blood and human embryos to treat a host of conditions from diabetes to muscular dystrophy, erectile dysfunction and breast augmentation. "All these clinics claim success in treating patients from India and abroad, but none has published data from controlled clinical trials," says Krishnamurthy Kannan, stem cell expert and biotechnology professor at the Indraprastha University in New Delhi.
But Ananda Rao, founder of Bangalore-based International Stem Cell Services — one of the many companies, clinics and hospitals offering stem cell therapies in India — argues that insistence on clinical trials of stem cells as done in drug trials of small molecules "is illogical." He says large number of trials done in India and abroad have clearly established the safety and efficacy of adult stem cell therapies and so "it is enough if our regulators ensure that the cells used for therapy are clinical grade."
Stem cell companies can not undertake expensive clinical trials when they can not patent their products like pharma companies do. He says the guidelines have only created unnecessary hurdles for doctors trying to save the lives of patients who opt for stem cell therapy as last resort.
Anant Bagul, orthopaedic surgeon and founder of Chaitanya Stem Cell Centre in Pune, agrees. "Melanocyte (skin cell) transplant is practised by dermatologists worldwide to treat vitiligo and is accepted in India for the last 15 years. Why bring this under clinical trials?" he asks. "We will challenge (the guidelines) in court."
Himanshu Patel of Ahmedabad-based Stemcure India says the guidelines will only hurt medical tourism, a major foreign exchange earner for the country.
One fallout of the new rules is the 'limbal stem cell therapy' to treat corneal blindness pioneered by L. V. Prasad Eye Institute (LVPEI) in Hyderabad in 2001 and routinely offered by a few other hospitals. Under the new guidelines, hospitals must now get a licence from DCGI to use this method on patients. Dorairajan Balasubramanian, research director of LVPEI says he has requested DBT and the ICMR to include this therapy as an approved procedure "since over 250 long-term outcomes have been published."
Some stem cell companies like Stempeutics in Bangalore are falling in line though. "Our first product Stempeucel is currently undergoing phase-II trial for three diseases: osteoarthritis, liver cirrhosis and critical limb ischemia (a condition that restricts blood flow to the limbs)," its CEO, Balu Manohar, told Nature India. Satish Totey, CEO of Mumbai-based Kasiak Research says his company favours clinical trials but approvals for trials should be given promptly. "We submitted clinical trials protocols for our product to DCGI in 2011 and completed all the formalities but are still awaiting approval. While legitimate companies wait, clinics not doing clinical trials are minting money."
Gopal Pande, chief scientist at the Centre for Cellular and Molecular Biology in Hyderabad, who was involved in drafting the guidance document for the DCGI says that things will get streamlined soon. "An executive order is all that is needed to modify rule-21 to include stem cells as new drug and this is expected to happen by June," he says. "After that you will see all fraudulent stem cell clinics close shop."