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www.expresspharmaonline.com FORTNIGHTLY INSIGHT FOR PHARMA PROFESSIONALS
1-15 November 2006  
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Stem cell research: The Indian perspective

Slowly but steadily, stem cells are trickling down the pharma research avenue. Dr Alka Sharma, Principal Scientific Officer, Department of Biotechnology, Ministry of Science & Technology, Government of India, does a status check on stem cell research in India.

Stem cell biology is an exciting field of life science today because of unique characteristics of stem cells like self-proliferation, migration and differentiation. This area has become the focus of intense scientific debate as stem cells offer hope for medical advancement and promising avenues to find a cure for many diseases. In India, stem cell research has been initiated with the aim to promote both basic and translational research. Over 35 institutions or hospitals are involved in various aspects of adult and embryonic stem cell research. The Department of Biotechnology under the Ministry of Science & Technology and other science agencies are promoting stem cell research in the country. Programmes supported on adult stem cells include mesenchymal, limbal, haematopoitic, neural, liver, cardiac, pancreatic, human corneal and stem cell preservation.

Research is on

In one of the programmes at L V Prasad Eye Institute (LVPEI), Hyderabad, limbal stem cells are being used to repair cornea surface disorders. Till date, more than 300 patients have been treated at this institute. In the programme supported at Christian Medical College (CMC), Vellore, a technology was established for collection, isolation and purification of haematopoietic stem cells (HSCs) for haploidentical HSC transplantation. The first haploidentical stem cell transplantation was carried out on April 2, 2003 at CMC. The programmes also support generation of human embryonic stem cell (ESC) lines and differentiation of ESC into different lineages. City cluster programmes have been implemented in the country by involving basic researchers and clinicians. This includes sharing information, exploring collaboration with clinicians and discuss emerging policy issues.

In India, clinical research using stem cells is in its infancy stage. The Department has supported Phase I multi-centric clinical trial using bone marrow mononuclear cells on acute myocardial infarction at five hospitals in the country, that is, CMC; Sanjay Gandhi Post Graduate Institute for Medical Sciences (SGPGIMS), Lucknow; Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh; Research & Referral Hospital, New Delhi; Air Force Medical College (AFMC), Pune and All India Institute of Medical Sciences (AIIMS), New Delhi. The pilot study on acute ischemic stroke has also been initiated at AIIMS. The main study would be started based on the findings of pilot study. A CMC-DBT Centre for Stem Cell Research is being established at CMC, with the support of the Department of Biotechnology. Stem cell research facilities are also being created at PGIMER. National Centre for Biological Science (NCBS) and Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR), Bangalore is providing training for both embryonic and adult stem cells.

Clean room facilities to handle stem cells are being created at SGPGIMS; KEM Hospital, Mumbai; LVPEI. Dedicated short and long term overseas fellowship programmes are being initiated for providing training to about ten fellows every year, fully paid by the Government of India.

Apart from the government, some industries are also involved in stem cell research. Reliance Life Sciences, Mumbai has characterised 10 stem cell lines, including two neuronal cell lines, dopamine producing neurons and neurons for patients of stroke. One cell line has been deposited in National Centre for Cell Science (NCCS), Pune. Their research focus is on ESC, HSC, treatment of leukaemia, sickle cell anaemia, skin and tissue engineering.

Committed to stem cells

Separate committees have been constituted to consider clinical trial proposals. The committees are: a) Human Studies committee to discuss and develop the clinical research protocol, b) Ethical committee for stem cell research to consider ethical issues involved in the clinical research proposal, c) Task Force to evaluate basic research proposal and also recommend funding for clinical research based on the evaluation of above committees and d) Programme Advisory Committee to consider the Centre of Excellence proposals.

Human resource development is important as creation of a critical mass of stem cell researchers in the country is the need of the hour

In India, the strategy for promoting stem cell research is gradually taking shape. The main features of strategy for stem cell research are to promote basic and translational research in the country; establish Centre of Excellence (CoE); virtual network of centres; generation of adequate human Embryonic Stem Cell (hESC) lines; human resource development through training; short and long term overseas fellowships. The short-term goal is to study biology of all types of adult stem cells and in parallel, evaluate safety and efficacy in animal models. The strategy also includes creation of good infrastructure to handle stem cells. Human resource development is the most important component of the strategy as creation of a critical mass of stem cell researchers in the country is the need of the hour. This will be achieved by supporting extensive training programmes; close interactions between basic scientists and clinical researchers; international collaboration including personnel exchange programmes; annual conferences; and workshops.

In order to boost public-private-partnership effort in the country, the Department of Biotechnology has initiated a new scheme called Small Business Innovation Research Initiative (SBIRI). The distinctive feature of SBIRI is to provide support to the high-risk pre-proof-of-concept research and late stage development in small and medium companies, lead by innovators with science backgrounds, which is unique in nature to support private industry. It also gets them involved in development of such products and processes, which have high societal relevance. SBIRI has unique process for generating ideas by bringing users and producers of technology together. It has direct focus on producing product and a sense of urgency for producing defined results that only private sector engagement can produce. The scheme covers all areas in biotechnology related to healthcare, agriculture, industrial processes and environmental biotechnology, and bio-medical devices and instruments.

In the area of stem cell research, the industry may play an important role in setting up a stem cell bank in public-private partnership model to have repository for all types of stem cells. It may also help to resolve the issue of availability of good quality research material. Public-private partnership may also be an ideal model for large-scale production of mesenchymal stem cells (MSCs) under cGMP conditions. Once the process is standardised and the product is established, the industry may take up further production and scale up for commercialisation.

Draft guidelines for stem cell research

The Department of Biotechnology under the Ministry of Science and Technology and Indian Council of Medical Research have jointly formulated draft guidelines for stem cell research. The guidelines are currently being placed for public debate. As per the guidelines, stem cell research has been classified under permissible, restricted and prohibited categories. The research pertaining to adult and umbilical cord blood stem cells would be classified as permissible. It would require approval from institutional committee. However, embryonic stem cell research falls under restricted category. It can be carried out with the approval of institutional committees and National Apex Committee. Research pertaining to reproductive cloning and introducing animal embryos in humans has been categorised as prohibited.

 


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