Stem Cell Research: The Art of the Possible

Stem cell research market in India is estimated to be about $540 million by 2010. Nancy Singh tells you why India is emerging as a research hub for stem cell.

From a few institutes two years back, today over 30 institutions are involved in stem cell research, and India too has joined the ranks. "The Government has invested $8 million on stem cell research over the last two years. Now several Government agencies too are supporting this," says Dr Alka Sharma, Principal Scientific Officer, Department of Biotechnology, Government of India, New Delhi.

The Goal

Today, the ultimate dream of scientists is to be able to rebuild, in vitro (outside the body), spare parts to replace injured or diseased tissues. The concept that stem cells can give rise to and maintain mature tissues has made adult stem cells the focus of intense research, designed to explore their promise for the treatment of a variety of human diseases.

The goal of stem cell therapy is to repair a damaged tissue that can't heal itself. This might be accomplished by transplanting stem cells into the damaged area and directing them to grow to a new, healthy tissue. It may also be possible to 'coax' stem cells already in the body to work overtime and produce new tissue. To date, researchers have found more success with stem cell transplants.

Market leaders

"The biggest risk that embryonic stem cell treatment poses is teratomas or tumors" - Dr Satish Totey Secretary Stem Cell Research Forum India

Considering the immense interest worldwide, it comes as no surprise that the global market for stem cell therapy is expected to be $20 billion by 2010, as per a Frost & Sullivan study. There are almost 180 prominent companies working on stem cell research in the world, majority of which is based in the US, followed by the EU, Israel, Thailand, Canada, and Australia.

And not to be left behind, India and China are poised to play a key role in the scientific, clinical and commercial development of stem cell research. According to Dr Totey, Director of Manipal Institute of Regenerative Medicine, Banglore and Secretary of SCRFI, "India is expected to have a market share of about $540 million by 2010 with an annual growth rate of 15 per cent."

If India is still at a nascent stage as compared to the world, what makes them vouch for India and China? “It is our huge population base with so much genetic versatility, for which companies are eyeing India," believes Dr D Balasubramanian, President, SCRFI and Director of Research at L V Prasad Eye Institute, Hyderabad. Experts rule out the possibility of being passively involved as 'guinea pigs'. "We are driven by the fact that the patient demand is high. Additionally, with its vibrant pharmaceutical and biotechnological companies, a large intellectual pool of scientific talent and a mature information technology industry, the country can boast of a big platform for research and its clinical application, which no other country has," explains Subramanian.

India Poised

The early starters include National Centre For Cell Sciences (Pune), the Indian Institute of Sciences (Bangalore) as well as AIIMS which has been doing pioneering work in this regard, with its main focus on adult stem cells and umbilical cord blood stem cells.

Though ethical and Governmental barriers impede stem cell research in Western (read Catholic) countries, particularly involving embryonic stem cells - experts believe that such barriers adds to the advantage for countries like India, which has a large pool of scientific talent and do not face such opposition.

There is some early evidence that SCT may be able to cure ailments like diabetes, Parkinson's, heart diseases, Alzheimer's and cancer.

"The biggest risk that embryonic stem cell treatment poses as a result, is that of teratomas — tumors and antigen-antibody reactions," says Dr Totey. There's another problem. In Western countries, it is the Church that has raised an objection to stem cell research, with its stance against abortion. According to some critics, which also include US President George W Bush, stem cells are mostly derived from embryos that have the potential to create life, hence any research involving such stem cells is akin to murder. As a result of these views, research has been slow, especially in the area of embryonic stem cells globally.

The unanimous feeling is that India is well positioned to emerge as a significant player in the global stem cell research area. "India is particularly interested in the clinical application of stem cells in ophthalmology, cardiology, diabetes, and spinal cord repair," says Dr Balasubramanian.

"Stem cell research guidelines will be placed for public debate soon" - Dr Geeta Jotwani Principal Scientific Officer Stem Cell Research, ICMR

One of the prime factors for a booming number of clinical trials is that, in India, the regulations have not been clear as yet. Draft guidelines for stem cell research have been formulated jointly by the Department of Biotechnology under Ministry of Science and Indian Council for Medical Research (ICMR), New Delhi. "The draft document was discussed jointly by both the Committees so as to finalise it. The guidelines will be placed for public debate soon," informs Dr Geeta Jotwani, Principal Scientific Officer, Stem Cell Research, ICMR.

The other edge India has is its cost-effectiveness. The same treatment, peripheral blood mononuclear therapy which costs $34,000 in Bangkok is only $ 5,000 in India.

Experts unanimously voice that the National Apex Committee (NAC), as mentioned in the ICMR guidelines, should be formed at the earliest to regulate the stem cell work and therapy. "It is better to have one apex body controlling the affair rather than various bodies like ICMR, DBT or DCGI trying to control a portion of such newer technological developments and their applications," feels Dr Samuel Abraham, Director, Nichi-In Centre for Regenerative Medicine, Chennai.

However, concerns are being raised over the possibility that stem cell research in India may leave Indian doctors virtually free to conduct stem cell research without following established scientific principles and medical ethics. "No," says Dr Sanjay Cherian,Director, Frontier Lifeline Hospital, Chennai, "Stem cells research requires infrastructure and intellectual pool. I believe it is difficult not to adhere to set guidelines."

Apart from the Government, some industry research organisations are also involved in stem cell research. Reliance Life Sciences has characterised 10 stem cell lines including two neural SC lines, dopamine producing neurons and neurons for stroke patients.

A Hyderabad-based lab, the Center for Cellular and Molecular Biology (CCMB), is quietly trying to grow transplantable corneas in vitro from limbal stem cells. LV Prasad and CCMB are two of about 15 laboratories across India, in cities like Hyderabad, Pune, Mumbai, Bangalore, and New Delhi, engaged in stem cell research and clinical application. Many are moving from animal to human studies.

"Multi-centric phase-I clinical studies have been implemented for safety and efficacy studies of bone marrow mononuclear cells in acute myocardial infarction and acute stroke. The multi-centric phase-I study on limb ischemia is also under consideration by the department," informs Dr Alka Sharma.

Twist in the Tale?

Research work in progress at Stempeutics, Banglore

Ethicists are taking note of the claim of scientists being able to isolate embryonic stem cells without causing any further harm to the embryo. This claim pertains to a study published in Nature in August 2006 by researchers of Advanced Cell Technology that describes a procedure used to launch a stem cell line without ill-effects to the embryo. The new approach is modelled after a procedure that has been used successfully in fertility clinics last 10 years. In fertility clinics, the procedure involves taking a single cell (blastomere cell) from an eight-cell embryo for genetic testing to exclude conditions like Down's syndrome prior to implantation of the now seven-cell structure into the mother. Researchers have found that in mice, this same technique has yielded stem cell cultures without destroying the remaining seven blastomere cells. Dr Robert Lanza, who lead the new study, believes the same can be done with human blastomeres. Using a similar approach in mice, scientists have succeeded in extracting a cell from an eight-cell embryo to successfully create a stem cell line, and, once again, the seven-cell embryo has gone on to develop normally.

Researchers say the success on humans remains to be confirmed by other researchers, and there are legitimate debates about whether this approach can be effective, and whether it's applicable for exploration of specific diseases like Alzheimer's or Parkinson's. The promise of embryonic stem cells lies in their ability to be 'pluripotent’ and develop into any other cell type. Experts envision a future where stem cells might help to replace diseased or injured tissue, thereby treating a host of ailments. We have to wait and watch, if this technique adds a new dimension to embryonic stem cell research.

Much Ado About Nothing?

Worldwide we are at the stage where stem cell research is moving from animal models to clinics. Though some progress has been made, there has also been a lot of hype. It will take at least a decade or so even for the clinical applications of stem cells. "Most companies are investing in the 'sexiness' of the field. So, there has to be delivery soon and I believe it would not be embryonic stem cells," says Alan Colman, CEO, ES Cell International, Singapore.

nancy.singh@expressindia.com