Stem cell dilemma

How clinics use embryonic therapy not approved by ICMR

By Dinsa Sachan
Published: Wednesday 29 February 2012

NIKUNJ Dewan is 23 years old. Unlike others his age he does not attend college; he neither parties with his friends nor goes to the cinema every weekend. Reason: He injured his spinal cord in a paragliding accident two years ago. It left his lower body paralysed. But as he is wheeled into a clinic that provides human embryonic stem cell therapy, the Delhi’ite is optimistic he will be running soon. He has been injected with stem cells four times.“After every session, I’ve felt significant improvements in my condition,” he says.

While many more people like Dewan have found a ray of hope in the use of embryonic stem cell therapy, its use is not allowed. The Indian government does not approve of any of the therapies employing human embryonic stem cells for use in the clinical set-ups.

Stem cell guidelines were issued by the Indian Council for Medical Research (ICMR) and the Department of Biotechnology (DBT) in 2007. These guidelines say: “As of date, there is no approved indication for stem cell therapy as a part of routine medical practice, other than Bone Marrow Transplantation (BMT). Accordingly all stem cell therapy other than BMT shall be treated as experimental. It should be conducted only as clinical trial after approval of IC-SCRT (Institutional Committee for Stem Cell Research and Therapy)/IEC (Institutional Ethics Committee) and Drugs Controller General of India (for marketable products).” Apart from BMT, the government in 2010 approved the use of limbal stem cells (found in cornea) to treat blindness.


Promise of stem cells
  • It is said that stem cells can help treat many diseases including cardiac diseases, Parkinson’s disease, diabetes and arthritis
  • Recently, cells derived from human embryonic stem cells helped improve vision in nearly two blind patients, one with Stargardt’s macular dystrophy—an inherited juvenile macular degeneration that causes progressive vision loss—and dry age-related macular degeneration. This is the first-ever medical use of stem cells taken from human embryos. The report appeared online in The Lancet on January 23
  • Another research has found that eyes are a source of neural stem cells. They can be coaxed to form other cell types. The study was published in the January issue of Cell Stem
  • In another study published in BMC Medicine, stem cells from cord blood were used to “re-educate” the immune system T cells of people with type 1 diabetes so their pancreas start producing insulin again
  • Stem cells from umbilical cords were converted into other types of cells, which may eventually lead to new treatment options for spinal cord injuries and multiple sclerosis, among other nervous system diseases, reports the journal ACS Chemical Neuroscience

No need for trials

Though the guidelines also clearly mention that DCGI approval needs to be taken to start a trial, most of the clinics do not obtain clearance. Also, every research institute must have an institutional stem cell ethics committee which must approve the clinical trials. In cases where human embryonic stem cells are involved, the permission must also be sought from a national apex committee under ICMR.

Take the case of Nutech Mediworld, run by Geeta Shroff, former IVF expert-turned-stem cell therapist, where Dewan is a patient. She claims to have treated more than 1,000 patients since 2002 but her work has not been published in any scientific or medical journal. Shroff says her technology is patented and she does not need to go through the publishing route. “None of my patients has shown any side effects,” she adds.

Just like Shroff, other organisations offering treatment are not too keen to carry out clinical trials. Ashish Verma, former colleague of Shroff, offers a therapy called leucocyte-induced therapy which mobilises stem cells in the body for incurable conditions like rheumatoid arthritis, glaucoma and interstitial lung diseases (condition where tissue and space around the air sacs of the lungs are affected) at Holy Angels Hospital in south Delhi. He says that clinical trials are expensive, and sometimes patients who come for the treatment are terminally ill or have incurable ailments. You also need to employ double blind clinical trials where only half of the patients get the treatment and other half act as control. This puts the control group at risk.


What is cord banking?
There are two types of cord blood bank—private and public. Private banks store cord blood for 21 years. This blood is given to the donor when the need arrives. A public cord blood bank works like a normal blood bank and anybody can donate.

On requirement you are given the blood from the bank that matches yours. Experts say, when it comes to umbilical cord blood cells, most conditions require an allogenic (from one person to another) stem cell transfer, and autologous stem cell transfer (person’s own stem cells are used for treatment) is needed in very few cases. The research on cord blood stem cell therapies is also in its nascent stage

“This is a baseless excuse,” says S S Agarwal, chairperson of the drafting committee of India’s stem cell research guidelines. “As per the guidelines double blind clinical trials are not needed”, he says, adding that open trials (where all the patients and researcher know what treatment is being given) are also allowed. Clinical trials are done to ensure that everything happens in a standardised manner, he adds.

Unistem, another company that is involved in stem cell research, says that it offers stem cell therapy by utilising umbilical cord tissue cells for various neurological conditions as “experimental therapy” so it does not need to go through clinical trials. “Experimental therapy is based on the results obtained from animal studies. It builds up enough evidence to establish the safety and efficacy of treatment on humans,” says Lalit Jaiswal, CEO of Unistem. But Ranjit Roy Choudhury, chairperson, Task Force for Research, Apollo Hospitals Educational and Research Foundation, refutes the claim. “You have to conduct clinical trials, and then publish your results. This is how science progresses. If a doctor thinks he or she has got a potential treatment, what’s the harm in standardising it?” he asks.

Brisk business

Though not approved, in the absence of any checks, the clinics continue to thrive and make money. At Shroff’s clinic, spinal cord injury treatment, lasting up to eight weeks, could cost between Rs 3 and Rs 5 lakh. Treatment for osteoarthritis for 10 days costs between Rs 10,000 and Rs 1 lakh, depending on whether one opts for physiotherapy, in-house care and food.

The current guidelines do not apply to such clinics. Agarwal says the clinics fall outside the purview of the guidelines which apply only to basic research and clinical trials. “It is the responsibility of the Medical Council of India to look into the clinics,” he adds.

The stem cell business also has another offshoot: cord blood banking. The cord blood stem cells derived from the umblical cord of a new born have been found effective in the treatment of certain diseases.

There are more than 10 cord blood banks in India and the major players include Reliance, LifeCell and CryoSave (see ‘What is cord banking?’). Market research firms and industry experts estimate that the global market worth of cord blood stem cells will shoot up to US $7.2 billion this year. The companies claim that in future cord blood cells can be used to treat almost all diseases and lure parents.

But Agarwal says there’s only one chance in 20,000 of a child ever needing his cord blood. “Gullible consumers shell out Rs 70,000–80,000 unnecessarily,” he adds. Rajesh Sharma, CEO of CryoSave, says, “We are very clear in what we tell people. We tell them that currently only certain blood disorders and paediatric conditions can be treated with cord blood cells.”

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