A well-defined regulatory pathway and guidelines are needed to carry
forward stem cell research and to bring out promising stem cell therapy
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Six-year-old Harshita, who was
suffering from a genetic disease – thalassemia major – got a new lease
of life following a successful stem cell transplant in New Delhi.
Similarly, millions of people suffering from different diseases such as
diabetes; cardiovascular disorders; neurological disorders; burns and
wounds; osteoarthritis; osteoporosis; bone, cartilage and liver
disorders; congenital abnormalities; and neoplasms, will get the
benefits from stem cell therapies.
India is one of the few countries in the world pursuing stem cell
research. But regenerative medicine, comprising stem cell therapies and
tissue engineered products, has a long way to go. Commenting on the
prospects of stem cell therapy, Mr KV Subramaniam, president and CEO,
Reliance Life Sciences, says, “In India, about 164 million patients –
suffering from diabetes, cardiovascular disorders, neurological
disorders, burns and wounds, osteoarthritis, osteoporosis, bone,
cartilage (joints & replacements), liver disorders, congenital
abnormalities and neoplasms – will benefit from stem cell therapies by
the end of 2011. Stem cell therapies are proved to be effective for
ocular, cardiovascular, and neurological disorders. With growing
interest of private companies in this domain and support from the
government bodies, stem cell therapy holds great potential to emerge as
the promising therapy.�
“India shows more interest in stem cell research. Over 40 institutions,
hospitals and companies are involved in stem cell research in the
country. Till date, more than 90 programs have been implemented on
various aspects of embryonic, iPS and adult stem cells. A few human
embryonic stem cell (ESC) lines have been generated in some of
the institutions and are deposited in UK Stem Cell Bank and National
Center for Cell Science, Pune. These cell lines are being used by the
national and international researchers for research purpose,� adds, Dr
Alka Sharma, joint director, Department of Biotechnology, Government of
India. Promoting stem cell research is one of her focus areas.
Current Scenario
According to reports, LV Prasad Eye Institute from Hyderabad has
treated 600 corneal epithelium cases using stem cells, with 80 percent
success rate. All India Institute of Medical Sciences (AIIMS), New
Delhi; National Institute for Research in Reproductive Health (NIRRH),
Mumbai; National Center for Cell Science, Pune; Center for Cellular and
Molecular Biology, Hyderabad; National Center for Biological Sciences
(NCBS), Bangalore; and Sankara Nethralaya, Chennai; are the other
institutes which are working on stem cells. Most of these institutes
focus on regeneration of damaged muscles as a result of heart attack,
stroke or cornea damage. While companies like Reliance Life Sciences,
Cryobanks International India, CordLife and LifeCell have created
facilities to store stem cells from umbilical cord.
“Reliance Life Sciences has launched the first commercially available
autologous limbal stem cell therapy, ReliNethra, for patients suffering
from unilateral corneal blindness. Recently, we launched ReliHeal – G
(biopolymeric hydrogel wound management product) that promotes
migration of new epidermal cells across the wound surface and is
beneficial for early wound healing. We have also completed clinical
trials using mesenchymal stem cells derived from the patient's bone
marrow for myocardial infarction and we are carrying out clinical
trials for application of stem cell-based therapies for stable
vitiligo, non-healing diabetic ulcers, Parkinson's disease spinal cord
injury and autologous stem cell conjuctival graft,� says Mr Subramaniam.
Nichi-In Center for Regenerative Medicine (NCRM) is one of the few
companies that is working on corneal epithelial stem cells. Apart from
corneal stem cells, NCRM focuses on in vitro expansion of bone marrow
and cord blood derived hematopoietic stem cells, which is expected to
be a boon for leukemia patients.
“We mainly focus on degenerative diseases and have worked on
osteoarthritis, spinal chord injury, for which trials have been done on
eight patients and no side-effects were identified. In coordination
with Dr KR Suresh, head of the department and consultant, Vascular
Surgeon, Bhagwan Mahaveer Jain Hospital, Bangalore, we have started
working on the treatment for critical limb vascular ischemia since 2005
and the phase I trials have been successfully completed and the study
results were published in the Journal of Vascular Surgery in 2009. We
are planning to extend the study to phase II. Nearly 70-80 patients
with critical limb vascular ischemia have been treated so far and in
last one year, we have treated 25 patients with osteoarthritis and 15
patients with chronic renal failure,� says Mr Gururaj Rao, research
director, International Stemcell Services, Bangalore, which offers stem
cell banking for regenerative medicine facilities including stem cell
therapies, banking, expansion and differentiation.
India Market
Even though the stem cell research has emerged as a new branch of
therapy with many institutes showing interest, it still remains a
controversial topic amongst the public. And the main challenges faced
are the lack of expertise, infrastructure, interdisciplinary network of
researchers and clinicians for theme-based research, well-defined basic
research leading to clinical/translational research and appropriate
regulatory mechanisms.
“The issues related to ethics are focused on embryonic stem cells. No
ethical issues were raised against iPS cells, but it might take another
decade or two for iPS cells to reach the bedside. We have been working
on adult stem cells, where the issues are mainly scientific rather than
ethics. When the safety and efficacy are proved, it will become a
routine therapy, as there is no issue related to misusing embryos,�
says Mr Samuel JK Abraham, director, Nichi-In Center for Regenerative
Medicine (NCRM), which carries out research, training and clinical
applications-protocol development in regenerative medicine.
“No stem cells are universal that could address all the diseases. Bone
marrow-derived stem cells may be good for few diseases but may not be
good for others. Therefore, it is necessary to look and investigate new
stem cells present in the human body that may be good and have certain
therapeutics potential. But, the major hurdle faced is that there is no
proven data that the stem cells are totally safe. Until we finish the
clinical trial, it is not recommended to use stem cells for any
diseases as therapy. People have little knowledge about scientific
methods, overall process of science and their usefulness. Hence, the
probability of people getting cheated are on high,� says Dr Satish
Totey, president, Advanced Neuro-Science Allies (ANSA), which focuses
on stem cell research and therapy primarily in neurological disorders
and other diseases.
“Many hospitals in India do not follow quality control since the stem
cell injections are for parental use. Instead of creating controversy
over stem cell therapy, regulatory bodies or committees should control
very basic rule of Indian FDA that any injectable solution in India
need certain facility and parameter and quality testing before
injecting it in human or animal. Except bone marrow transplantation for
cancer patient, no other therapies are yet proven and are a standard
medical practice,� adds Dr Totey.
The lack of awareness is one of the serious problems faced in stem cell
research. With no proper trials or follow up the treatment is reaching
the public. Many researchers and practitioners are aiming at the
commercial aspect of it, thereby harming the human society.
“If proper awareness is given, people would encourage the new
treatment. But, the only problem is that there is no regulation in this
field. We have many doctors in New Delhi, who claim to treat many
diseases using stem cell therapy and they charge $7,500-$8,500 (
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3.5-4
lakh) per injection. This is a grave issue which needs to be addressed.
Even without proper approval by any regulatory body, practitioners are
indulging in various treatments using stem cells, which is not at all
safe. The rules are mainly followed to meet the pharmaceuticals
requirements. Like pharmaceuticals, one cannot approve stem cells on
the basis of dose-response ratio. Hence, the drug control rules are not
applicable when it come to stem cell therapy,� says Mr Rao.
Sharing his thoughts on the issues before the stem cell research
community, Dr Totey says, “There is no proper policy in this country
and currently it is free for all kind of situation. Funding is very low
and therefore the available funding cannot address all the potential
ideas and good science. Funding is mainly alloted for low risk project,
which is a barrier for innovation. R&D is not for public use. It is
largely accessible to only select group of people. There are only a few
clinical trials which get approval from Drug Controller General of
India (DCGI). The central government should have clear mandate about
their requirement rather than allocating funds for free. They should
look for priorities and identify potential problem diseases in India.
They should identify groups and expertise and give them a timeline to
bring this product in the market for the needy patients. After which
they can give these therapies to industry at a low cost so that the
patients get benefited.�
Considering the huge potential for stem cell market, many global
players are eying India. “The government authorities should provide
fund for clinical trials instead of basic research. Encouraging basic
research is needed but doing just basic research won't help.
Practically, clinical trials should be encouraged to make the research
more effective. If India does not move ahead with trials then foreign
players will soon emerge ahead in the market,� says Mr Rao.
With a lot of vulnerable factors attached to this therapy, the role of
authorities and need for regulation is of much importance. A
well-defined regulatory pathway and guidelines are needed to carry
forward the stem cell research.
Organizations
working on stem cells |
Reliance Life Science, Mumbai |
Stemputics, Bangalore |
International Stemcell Services,
Bangalore |
Advanced Neuro-Science Allies
(ANSA), Bangalore |
Nichi-In Center for Regenerative
Medicine (NCRM), Chennai |
All India Institute of Medical
Sciences (AIIMS), New Delhi |
National Institute for Research
in Reproductive Health (NIRRH), Mumbai |
National Center for Cell Science,
Pune |
LV Prasad Eye Institute,
Hyderabad |
Center for Cellular and Molecular
Biology, Hyderabad |
National Center for Biological
Sciences (NCBS), Bangalore |
Sankara Nethralaya, Chennai |
Bhagwan Mahaveer Jain Hospital
(Jivas), Bangalore |
Indian Institute of Science (IISc),
Bangalore |
National Brain Research Center
(NBRC), Haryana |
Centre for DNA Fingerprinting and
Diagnostics (CDFD), Hyderabad |
Nizam's Institute of Medical
Sciences, Hyderabad |
Tata Institute of Fundamental
Research (TIFR), Mumbai |
National Institute of Mental
Health and Neuro Sciences (NIMHANS), Bangalore |
Post Graduate Institute of
Medical Sciences (PGIMER), Chandigarh |
National Institute of
Immunohaematology (IIH), Mumbai |
LifeCell, Chennai |
Pacific Stem Cells, Hyderabad |
Cryobanks International India,
Gurgaon |
CordLife, Kolkata |
Even when controversies are on a high, the Department of Biotechnology
(DBT), Government of India, has allocated $650,000 (
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3 crore) in the last five years towards
basic and applied research in stem cell technology.
The Indian Council of Medical Research and the DBT had already
announced the guidelines for stem cell research and therapy in 2007,
but India is yet to formulate norms for stem cell banking and storage
procedures. The stem cell banking in India is yet to come under a
regulatory framework. Moreover, Stem cell continues to be a promising
field, which will rise to new levels in the coming years.
Quotes:
With growing interest of private companies
and support from the government bodies, stem cell therapy holds great
potential to emerge as the promising therapy.
– Mr KV Subramaniam, president and CEO, Reliance Life Sciences
The issues related to ethics are focused on
embryonic stem cells. No ethical issues were raised against iPS cells,
but it might take another decade or two for iPS cells to reach the
bedside.
– Mr Samuel JK Abraham, director, Nichi-In Center for
Regenerative Medicine
Clinical trials should be encouraged to make
stem cell research more effective. If India does not move ahead with
trials then foreign players will soon emerge ahead in the market.
– Dr S Gururaj A Rao, chairman & managing director,
International Stem Cell Services
'Stem
cell research is one of the
thrust
areas for DBT'
- Dr Alka Sharma, joint director, Department of Biotechnology,
Ministry of Science and Technology, Government of India
Q Researchers
have found new sources of stem cells
such as corneal epithelium and bald scalps, what kind of support does
DBT offers for such research?
Stem cell research is one of the thrust areas of the Department of
Biotechnology (DBT). It is supporting proposals on various aspects of
stem cells including discovery of new sources of stem cells, and their
applications in animal models. Support for proposals on stem cells from
small and large biotech companies is also being considered and will get
implemented through public-private partnership schemes such as Small
Business Innovative Initiative (SIBRI) and Biotechnology Industry
Partnership Program (BIPP).
Q Last year, few meetings were organized by DBT to
discuss the guidelines
for stem cell research. What is the current status on these
developments?
Draft guidelines for stem cell research in the country have been
formulated jointly by the DBT and the Indian Council of Medical
Research (ICMR). These two agencies are working in close collaboration.
Region-wise public consultations were organized at four places in 2010.
The public consultation for the central region (northern region) is in
the pipeline. The recommendations will be finalized and implementation
report will be completed after the public consultation in the central
zone.
Q With many organizations targeting commercial
profit from stem cell research/ therapy, what role can the government
play as a regulator?
The guidelines for stem cell research have been formulated and the same
have been submitted to the Ministry of Health and Family Welfare for
further processing as a legislation. Once it is converted into an Act
with penalty clauses, it will help in regulating medical applications
and curbing misuse.
The DBT has constituted an independent “Ethics Committee for Stem Cell
Research� to consider the proposal from ethics point of view. Each
proposal cleared by the respective Institutional Ethics Committee (IEC)
is being considered by the DBT's Ethics Committee before processing.
Our processes for funding are very stringent. The ICMR has similar
credible arrangement.
Q What are the measures taken by the DBT to step-up
stem cell research in India?
As with all areas of biology, the limiting factor for stem cell
research is the inadequate number of scientists who specialize in stem
cells. DBT has initiated fellowship schemes such as Wellcome Trust
Fellowship and Ramalingaswamy Fellowship for increasing the talent pool
in the country.
The key components of our strategy are:
- Develop a skilled and brilliant pool of scientists in the
area of stem cells
- Establish Center of Excellence in basic science institutes,
medical
institutes and selected animal institutes
- Operationalization of autonomous stem cell institute in Bangalore
- Organize world-class science meetings
- Send young people for overseas training
- Support public-private partnership research
- Establish global partnerships
Suchithra Pillai in Bangalore