Cellular cure

Work in progress Indian regulation of stem cell research is still patchy, but patients are being treated for diabetes, muscular dystrophy, eye diseases, cancers, and nerve and skin disorders, reports Sanchita Sharma.

Imagine having a failing heart and doctors injecting healthy stem cells to replace the damaged ones.

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Or surgeons replacing a defective bladder not with a donor organ, but with a healthy, lab-grown one. While experts are working on the first, the latter has been done successfully.

Stem cell treatment is offering cures that would have been called miracles just a decade ago. Clinical trials are under way to use stem cells to treat incurable conditions such as Parkinson’s disease, diabetes, muscular dystrophy, leukemia; lymphoma, ovarian cancer, breast cancer, kidney and urinary cancer, skin tumour, blindness, among others.

There have been several successes. Scientists at the Wake Forest Institute for Regenerative Medicine at Winston-Salem – situated in the east coast state of North Carolina in the US – implanted bladders developed from stem cells in patients in 2006. Three years on, all of them are healthy.

Hope and hype
Hopes aroused by advances in stem cell research were what prompted the family of senior Congressman and former cabinet minister Priya Ranjan Dasmunsi to take him to Germany for stem cell therapy after he remained in a coma one year after a heart attack.

Dasmunsi was admitted to the All India Institute of Medical Sciences on October 12 last year following a heart attack, from which he has not recovered. He was shifted to Apollo Hospitals, where his condition remained stable but unchanged for over 12 months.

“In India, we got in touch with people like Dr Geeta Shroff but weren’t convinced with the way she conducted the procedure. The German doctors appeared to be more transparent in their approach. They will take cells from his body and culture them for use in his treatment,” said his wife, Deepa Dasmunsi, who has accompanied her husband to Germany.

IVF specialist-turned-stem cell expert Dr Geeta Shroff of NuTech Mediworld in central Delhi’s Gautam Nagar, claims to use embryonic stem cell lines developed from patients themselves and unused embryos of patients who visit her in-vitro fertilisation clinic, but inspections by the Indian Council of Medical Research (ICMR) – the overarching monitoring body that published the Ethical Guidelines for Biomedical Research on Human Subjects – surveyed her centre and found her claims unconvincing. Dr Shroff refused to comment.

IVF, short for in-vitro fertilisation, is an infertility treatment in which eggs are fertilised with the sperm outside the womb. More than one embryo is fertilised and the healthiest implanted back in the womb. Stem cells derived from the inner cell mass of the discarded early-stage embryos, called blastocysts, are called embryonic stem cells.

Hers is not the only clinic promising quick-fix stem cell cure for diseases ranging from muscular dystrophy to diabetes. “Not realising that stem cell treatment is still at an experimental stage, desperate patients are risking potentially dangerous side effects by becoming unsuspecting guinea pigs,” said Dr Katoch.

The future is here
“We are now working to engineer more than 20 different tissues a kidney, muscle, blood vessel, lung, heart and liver, using stem cells and in some cases, a patient’s own cells,” Dr George Weightman, chief operating officer, Wake Forest Institute of Regenerative Medicine, told Hindustan Times.

The range sums up the potential of stem cells, which are the foundation cells for every organ and tissue in the body. “Stem cells can be matured into any tissue type and used for the functional repair and replacement of diseased organs and tissues,” said Dr V.M. Katoch, secretary, department of health research, Union health ministry.

The market size for stem cell therapy is projected to increase from an estimated $30 billion (Rs 1,44,000 crore) in 2008 to $96 billion (Rs 4,60,800 crore) by 2015, giving hope to millions not responding to conventional treatment.

Monitoring cure
Along with the department of biotechnology, the ICMR is finalising the Biomedical Research on Human Subjects (Promotion and Regulation) Bill, which will be tabled in Parliament next year.

“The Ethical Guidelines are indirectly mandated through the Drugs and Cosmetics Act Schedule Y and amendments to the Medical and Health Council Act 2002, so action can be taken against researchers offering dubious treatment to patients desperate for a cure. Ethical researchers, however, always follow guidelines as they want validation for their work,” said Dr Nandini Kumar, deputy director general, ICMR.

Among the centres with validated projects are the All India Institute of Medical Sciences, New Delhi; Centre for Cellular and Molecular Biology, Hyderabad; Reliance Life Science, Navi Mumbai; Indian Institute of Science, Bangalore; and L V Prasad Eye Institute, Hyderabad. Research here focuses on treating nerve disorders, diabetes, muscular dystrophy, eye diseases (such as corneal blindness), cancers (blood, kidney and ovarian) and skin disorders.

“The Bill allows stem cell research and therapeutic cloning but restricts human cloning till its safety and benefits are proven. Effective regulation will give stem cell research the impetus it needs,” said Dr Katoch.

Regulation will also help weed out unscrupulous doctors hoodwinking chronically ill patients with promise of a cure.