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.
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
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