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www.expresspharmaonline.com FORTNIGHTLY INSIGHT FOR PHARMA PROFESSIONALS
1-15 December 2007  
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Home - Market - Article

Selling stem cells

While adult stem cell therapy currently dominates the global stem cells market with a share of almost 58 percent, the global stem cell market is expected to touch the $20 billion mark by 2010. Sushmi Dey finds out what is happening on the Indian front…

The subject of stem cells has always been both promising, as well as controversial, starting with the cloning of Dolly, the sheep, till the recent quagmire by a South Korean scientist, Hwang Woo-suk, who claimed he had cloned humans by faking results in nine of the 11 stem cell lines. Given the huge disease burden, the need for organs, affordable diagnostics and medicines, the promise that stem cells offer needs to be exploited to the fullest. Stem cells have brought in new hope for medical science and to medical professionals, who now look for treatment for incurable diseases and possibilities of an endless life. No wonder, experts call these cells "miracle cells".

However, there are pitfalls, in the form of false claims, unethical methods to get quick results or unregulated practices to harvest these miracle cells. Even as scientists and lay men alike remain divided on the hype, hope and ethical issues surrounding stem cells and cloning, countries have evolved their own policies, ranging from permissive to restrictive. In a recent development, India too has taken significant steps in this direction. The Department of Biotechnology (DBT) under the Ministry of Science and Technology and Indian Council of Medical Research (ICMR) has jointly formulated draft guidelines for stem cell research. "The Department of Biotechnology and ICMR has agreed on the guidelines for stem cells and the final guidelines will be made public on November 8, 2007," declared Dr NK Ganguly, Director General, ICMR.

The Indian Quotient

"The limiting factor is the very low density of scientists in stem cell research as compared to other countries"

- Dr Alka Sharma
Joint Director
Department of Biotechnology Government of India

Although at a nascent stage, stem cell therapies are a rapidly growing field in the Indian market. From a few institutions two years back, currently there over 40 institutions and hospitals that are involved in stem cell research in the country, says Dr Alka Sharma, Joint Director, Department of Biotechnology, Government of India. There are almost 180 prominent stem cells companies in the world. While majority of these companies are based out of the US, Europe, Israel, Thailand, Canada and Australia and are active in commercialisation, India too has joined the ranks. "There is a growing consensus, amongst the policy analyst and scientist alike, that India and China are poised to play a key role in the scientific, clinical and commercial development of stem cell research," says Dr Satish Totey, Chief Scientific Officer, Stempeutics Research, Manipal Hospital.

Market potential for stem cell therapy products in India and Asia-Pacific is very large. According to Totey, the estimated market of stem cells in India is $500 million. Utkarsh Palnitkar, Partner, Transaction Advisory Services and Leader—Policy and Investment Advisory Services, Ernst & Young agrees. "The Indian stem cells market is growing at a rate of 15 percent per annum and is expected to hit US $540 million by the year 2010," says Palnitkar. The recent tie up of several Indian companies with foreign collaborators is also evident of the trend of Indian market. "Private funding is to the tune of $100 million. Whereas, Stempeutics invest-ment itself is close to $10 million," adds Totey. The investment made by government funding in India is also quite large. "The government has invested about US $500 million on stem cell research over the last three years. Support to small and large biotech companies is also being considered through the Small Business Innovative Grant Initiative (SBIRI) scheme," informs Sharma.

In India though, interest is growing in stem cell research and its capacity is gradually building up, there are still miles to go. "As with all areas of biology, the limiting factor is the very low density of scientists in this area as compared to other countries," avers Sharma. The key components of DBT’s strategy are to develop a skilled and brilliant pool of scientists in this area, establish Centre of Excellence in basic science institutes, medical institutes and selected animal institutes, establish an autonomous stem cell institute in India, organise world class science meetings, send young people for overseas training, support public-private partnership research in R&D area and establish global partnerships. “The scientific strategy in the short run is to focus research on all types of adult stem cells and their biology, create capacity for GMP cell production in institutes and industry, study their safety and efficacy in animal models for diseases, and when appropriate, in human subjects,” says Sharma. The medium and long term strategy is to develop embryonic stem cell (ESC) lines and create the infrastructure to store and monitor these, to study the biology of ESCs and to contribute to the development of technologies that will make human therapy with cells derived from such cell lines without rejection possible in future," she adds.

Looking at Laws
A sampler of the laws exercised in various countries with respect to EC cell research-
Australia, Spain, Israel, and Singapore: Derivation and use of stem cells from spare embryos is permitted.
Austria : Embryo research is prohibited.
Canada : According to the 2001 Human Reproductive and Technology Bill, cloning is banned, but research on leftover embryos is allowed before 14 days of development.
China: Derivation and use of stem cell embryos for research purposes is permitted.
Finland: Embryos created for the purpose of research is prohibited.
Germany: It is illegal to derive cells from an embryo for research and diagnosis. However, import of human ES cell lines is allowed.
Ireland, Norway: Research of any kind on stem cells and embryos is forbidden.
India: ES cell research is permitted, but reproductive and therapeutic cloning is banned.
Italy: Cloning of human embryos for deriving stem cells for therapeutic purposes is permitted.
Netherlands: Allows research on supernumerary embryos, but prohibits the creation of human embryos for research purposes.
Sweden: Stem cells can be derived from embryos not older than 14 days. Creation of embryos for cloning and research purposes is prohibited.
Switzerland: Allowing the use of already derived and existing ES cells is being considered.
USA: Research on existing ES cell lines is permitted. Derivation of new cell lines from existing embryos is permitted. Creation of embryos for research purposes is prohibited.

(source: F&S report)

Standing Apart

"India can leverage upon the opportunities by fine tuning research skills by adequate training, bridging gap between clinicians and scientists and making one organisation to monitor ethical issues based on well defined regulations"

Dr Samuel JK Abraham
Director
Japanese Nichi-In Centre for Regenerative Medicines

Many Indian as well as foreign institutes and industry players have chosen India over developed countries of the world. "Stem cells will not have boundaries and areas that separate us from any market. In fact, if the disease is international then role of stem cells will also be international," says Dr Ramananda Nadig, COO, Stempeutics, Manipal Group. However, Nadig maintains that his company will start by demonstrating the model within India and then move to countries where the role of stem cells is known because India offers advantages for research and commercialisation of stem cells.

Besides government support and funding, India also has the advantage of large patient pool, a wide spectrum of diseases, which are not found in many developed nations, good strength of highly skilled clinicians, young paramedical, biotech workforce and favourable regulation, which will significantly help the country to develop as a global player in stem cells market. "I believe in ‘thinking global and acting local’, and am therefore looking at India. We could perhaps leverage the benefits of the results we obtain in India by bridging studies done for the rest of the world, thereby, making our home grown success international," reveals Nadig. With regulations and clinical research, there will be acceptance, and India can be a leader in stem cell therapy. Dr Samuel JK Abraham, Director of the Japanese Nichi-In Centre for Regenerative Medicines, Chennai, says, "India can leverage upon the opportunities of stem cells by fine tuning the research skills of its young brains by adequate training, by bridging the gap between clinicians and scientists and by making a single window organisation to over see and monitor ethical issues based on well defined regulations."

Miracle Cells
A stem cell is essentially the building block of the human body. The stem cells inside an embryo will eventually give rise to every cell, organ and tissue in the foetus's body. Unlike a regular cell, which can only replicate to create more of its own kind of cell, a stem cell is pluripotent. When it divides, it can make any one of the 220 different cells in the human body. Stem cells also have the capability to self-renew. They can reproduce themselves many times over.

There are two types of stem cells-embryonic stem cells (ES cells) and adult stem cells. Embryonic stem cells come from an embryo, the mass of cells in the earliest stage of human development that, if implanted in a woman's womb, will eventually grow into a fetus. When the embryo is between three and five days old, it contains stem cells, which are busily working to create the various organs and tissues that will make up the fetus. Adults also have stem cells in the heart, brain, bone marrow, lung and other organs. They are our built-in repair kits, regenerating cells damaged by disease, injury and everyday wear and tear. Adult stem cells were once believed to be more limited than stem cells, only giving rise to the same type of tissue from which they originated. But new research suggests that adult stem cells may have the potential to generate other types of cells, as well. For example, liver cells may be coaxed to produce insulin, which is normally made by the pancreas. This capability is known as plasticity or transdifferentiation. They are promising for treating several degenerating diseases.

Work in progress

The government is engaged in major capacity building effort to create an inter-connected, well managed stem cell research enterprise in the country. This is evident from the fact that the Department of Biotechnology has set up a separate task force on stem cell research and regenerative medicines with the eminent scientists and clinicians to deal with the stem cell proposals. The task force considers new proposals and monitors the progress of ongoing proposals of the basic and translation research in the area of both embryonic and adult stem cells. "The task force has sub-committees-one skilled in science, the other in clinical/pre-clinical aspects of project and third is for ethical clearances. This set up is more comprehensive than we use for other areas," explains Sharma.

NCRM is conducting corneal epithelial stem cell research for which animal studies are over and clinical study is expected to start in the near future. Animal studies are also over for acute liver failure at NCRM. The centre is also conducting clinical studies in spinal cord injury, liver cirrhosis and peripheral vascular disease which have shown good results in the initial follow-up. "Now we are working on expansion of autologous bone marrow hematopoetic stem cells, which will be useful not only for hematological malignancies but also multiple usages of bone marrow (HSCs) taken once and future applications after cryopreservation," informs Abraham.

Stempeutics has already derived four human embryonic stem cell lines and they are being characterised. "However, human embryonic stem cell lines are not for clinical purpose. They are only for research. We are very far away from developing therapies using human embryonic stem cells. Bone marrow derived mesenchymal stem cells are already in clinical therapy," explains Totey. While four clinical trials have been initiated, research on diabetes, cardiovascular area, Parkinson's disease, spinal cord injury, muscular dystrophy and immunology is currently going on at Stempeutics. Reportedly, Stempeutics is also the first Indian stem cell company and international company that has received Bionexus approval at Malaysia as a first foreign direct investment company. The company is tying up with several hospitals in Malaysia for stem cell therapy.

AIIMS has also claimed reasonable progress in therapeutic stem cell research work. Using bone marrow mononuclear cells, it has initiated clinical trials on about 40 patients. The focus is on treating muscular dystrophy, spinal cord injury, cerebral dysplasia, heart tissue damage, diabetes and motor neuron disease. Centre for Cellular and Molecular Biology (CCMB) is also doing significant work in the area of stem cells. Besides working in collaboration with the Deccan Medical College (DMC) for liver stem cell research, it has also done work with the L V Prasad Eye Institute in growing corneal limbal cells, which help in repairing the damaged corneal tissue and restoring vision. "Doctors have successfully performed more than 200 such procedures," informs Palnitkar. CCMB is also working with Biological E on the use of cord blood cells and is venturing into newer areas. "It has simultaneously built up facilities that can aid industry and other research institutes. For example, its nuclear magnetic resonance (NMR) imaging facility, being set up with the help of the Department of Science and Technology (DST), would allow imaging of cells and enable an insight into the effects of drug molecules at the cellular level. This would obviate the need to sacrifice animals for scientific experiments. It has also developed transgenic gene models of mice, for conducting drug trials," informs Palnitkar.

Overall, research efforts by the scientific community or industry are still at modest levels, though a few major groups are working in specific areas. As early as 2001, Reliance Life Sciences and National Centre for Biological Sciences, Pune, had built up facilities to preserve seven and three stem cell lines respectively.

ICMR Guidelines say …
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.

Hurdles ahead

Inspite of all the work going on in the country, there are some significant challenges as well which are plaguing the segment. Stem cell research raises many ethical, legal, scientific and policy issues that are of concern to the policy makers and public at large. Therefore, guidelines are needed in order to encourage responsible practices in the area of stem cell research and therapy and put proper safeguards in place to protect research participants receiving stem cell implants and patients at large from unproven therapies or remedies. "The guidelines formulated jointly by ICMR and DBT address derivation, propagation, differentiation, characterisation, banking and use of human stem cells for research and therapy. The guidelines provide a mechanism to ensure that a research within human stem cells is conducted in a responsible and ethically sensitive manner and complies with all regulatory requirements," explains Sharma.

However, although ICMR has brought regulatory guideline for stem cell research, there is still a lack of guideline for commercial activity and clinical therapy in India. "The US and Germany have restrictive policies on stem cell research and funding owing to ethical issues. In contrast, the UK, Singapore, Japan, South Korea, Belgium and Israel are more liberal. Taking the middle ground are countries such as Australia, Canada and Spain," opines Palnitkar. Besides regulatory guidelines, the availability of human resources of adequate expertise is another challenge for stem cells research in India. According to Sharma, there is a growing mass of scientists who are interested in stem cells but critical mass is still lacking and hence manpower development is another issue to be addressed on priority. "The central body which governs the stem cell research should have its own fully employed, well qualified and judicially bound staff and systems to protect confidentiality in matters pertaining to intellectual property rights and they can take the model of USFDA in this regard," suggests Abraham.

Although, India has enough resources for R&D and commercialisation of stem cell research, there are still a few loopholes. The infrastructure and skill in creating animal models for safety and efficacy is some what limited in India. The country requires several thousand additional life scientists. "The number of proposals is growing. We have received more than 100 proposals in this area in the past three years. In the whole life science area, the density of scientists is so low that this becomes a limiting factor," says Sharma. According to Abraham, tax free period for investments into research in this field will encourage private players to forge into this segment. "Like what they have in Malaysia, there should be a five to ten year tax free period for investments into research in this field. More soft loans and government grants should be in place, especially to private institutes, for stem cell research," opines Abraham.

Last but not the least, the use of embryonic stem cells has become a social issue in some societies. Many religious groups find the idea of using cells from human embryos morally unacceptable. whereas, others believe the ability to heal the living outweighs those concerns. The DBT has constituted an independent Ethics Commi-ttee for Stem Cell Research to consider the proposal from the 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.

Last word

The need of the hour is to have clear objectives in mind and a definite model for research. Defining standards and guidelines for institutes, for operating clinical trials, draw regulatory approval for India to attract investors, training for manufacturing of stem cells for clinical trials, need for disease specific meetings of scientists, clinicians and industry partners to help in better understandings can position India as a global leader in stem cells. "Only time will tell if the mythical possibilities of stem cells can be converted to a reality, but hopefully even if not a panacea for all diseases, at least it will offer significant improvement in diseases that currently have no cure. Even if not the sole form of therapy, stem cells will be an adjunct for a variety of diseases," says Nadig, who thinks perhaps India will lead from the front when it comes to stem cells and their use in therapy in the future.

sushmi.dey@expressindia.com

 


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