INDIA: Stemming Experiments in Stem Cells

• by Keya Acharya (bangalore)
• Monday, February 14, 2011
• Inter Press Service

With a 2 percent share of the 56-billion dollar world market, India enjoys one of the highest growth rates in stem cell treatment and is widely perceived to be a centre of stem cell work.

But scientists across the board say successful treatments are a long way away and ethical questions, apart from health and scientific ones, have yet to be fully addressed.

'It’s a rather uncritical explanation that we’re already there,' says Dr. Jyotsna Dhawan, Dean of the Bangalore-based Institute of Stem Cell Biology and Regenerative Medicine. 'There is a big gap between reality and potential in the field worldwide.'

One reason for the fuss surrounding stem cell therapy is its potential to address a plethora of medical conditions. Stem cells are cells capable of renewing themselves through cell division, with research now focused on those taken from human embryos and umbilical cord blood.

In India, 22 public and seven private research institutions are authorised to conduct stem cell research.

The only stem cell therapy treatment tried and tested so far is bone marrow transplantation, allowed by the Indian Council of Medical Research (ICMR).

Nevertheless, several hospitals and clinics across major cities in India have treatments for neurological, cardiological and reproductive areas of medicine, the largest number being in central nervous system diseases and in soft tissue repair.

In 2007, India brought out a set of guidelines on conducting stem cell research, but the guidelines are not legally binding and have no power to curb clinical implementation of stem cell therapy.

Only 15 clinical trials have been officially registered so far. Dhawan said several of these went well, such as stem cell research using corneal epithelium conducted by the LV Prasad Institute in Hyderabad.

But unregistered work and treatment are being conducted in various places in India.

The most prominent of these is in the New Delhi-based Nutech Mediworld clinic set up by Dr. Geeta Shroff which treats patients, many of them from abroad, through human embryonic stem cells.

Shroff’s brochure says she has not had a single patient showing any adverse side effects.

'I would have forgiven (stem cell therapy clinics) if their objective was to treat a patient,' says Dr. Pushpa Bhargav, senior scientist and former director of the Hyderabad-based Centre for Molecular Biology.

'But the patients are being used for money. How many in India have been cured? None that I know of.'

The low cost of operations and easy availability of target participants has made India a prime destination for clinical trials. India and China became centres for stem cell work after the U.S. voted down legislation on stem cell research in 2006.

But while clinical trials are under way, questions have been raised whether these are done using the proper procedures.

Dr. Vasantha Muthuswamy, former ICMR deputy director general and founder-secretary of the Asia Pacific Ethics Review Committee, posed some questions: What steps are being taken to ensure cells are not contaminated? Are patients’ scores being recorded? Do theory and methodology of treatment 'make sense'?

Another critic is Dr. Maneesha Inamdar of the Jawaharlal Nehru Centre for Advanced Scientific Research in Bangalore, one of only two scientists in India to have developed new lines from stem cells now being used in Indian and foreign laboratories. Inamdar bluntly termed as 'dangerous' the commercial application of non-authorised therapy.

Several stem cell clinics contacted were wary of speaking to the media, revealing their awareness of the controversy surrounding their practice.

A staff member who answered a telephone call to a well-known stem cell treatment clinic in New Delhi refused to identify himself and said the number of cases treated in the clinic was proof enough of its efficacy.

ICMR director general Dr. V.M. Katoch told IPS he was 'very concerned' that such cases were only 'hearsay'.

Nevertheless, Katoch says control is now 'building up', with an ICMR clinical trial registry now online and awareness on setting up ethics committees improving 'by the month.'

He says India’s guidelines have been unable to keep up with practice in the field due to the absence of a single agency responsible for stem cell matters.

That may change soon, with guidelines having taken the form of a bill pending before Parliament. The guidelines have also been amended to include clinical conduct and penalties for offenders.

'We are now moving towards a far more regulated regime capable of taking on offenders, while building up development in the field,' Katoch told IPS.

For patients with degenerative diseases, none of this matters. One such patient is 34-year-old Chandana Sen who is suffering from ankylosing spondylitis, a condition where the spinal joints get fused.

Her father, retired Air Marshall D.K. Sen, said Chandana 'is willing to be a human guinea pig in stem cell treatment.'

The Sens are just typical of those now flocking to stem cell therapy clinics, too desperate to care about the controversy.

© Inter Press Service (2011) — All Rights ReservedOriginal source: Inter Press Service

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