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Annals of Neurosciences, Volume 16, Number 3, July 2009

Advancements in Stem Cell Research - An Indian Perspective

Stem cell research is a promising frontier in biomedical research and therapeutics that will permanently transform the way medicine is being practised. It has been more than half a decade since India ventured into stem cell research arena in a much extensive scale. Undoubtedly, India possesses the initiative, resources and pragmatism to acquire leadership in this important area of biology. The zeal exuded by the Government of India has led to the prompt identification of stem cells as a niche area requiring intense focus. Its translation in real-time is evidenced by its ever-increasing patronage in the form of grants towards infrastructure development and operational activities. In fact, a dedicated task force has been established under the auspices of Department of Biotechnology (DBT), Government of India to recognize the priority areas and to provide financial support to promote this area.

India is poised to acquire leadership in this area by exploiting both the embryonic and adult stem cells systems since neither alone is likely to meet all therapeutic needs. In fact, a lot of thrust has been given to understanding the basic and clinical biology, which are being pursued at various centres (both government and private alike) within the country. Fortunately the religious concerns especially with respect to embryonic stem cells derivation and usage are relatively non-existent in India. Indeed, the fundamental research on embryonic stem cells that could provide clues about developing understanding of the processes of cell differentiation and dedifferentiation would further enable harnessing of the potential of both embryonic and adult stem cells to their fullest extent. Moreover, since the stem cells from most of the lineages in adult retain astonishing level of plasticity, these could help in exploring their transdifferen-tiation potential, along with the lineage committed embryonic stem cells derived multipotent stem/progenitors, with a view to having possible application in therapeutic transplantations. Countries like India that possess rapidly growing population can exploit the power of stem cells in establishing authentic human embryonic stem cell lines as well as pioneering regenerative medicine. Establishment of stem cell lines using surplus IVF human embryos and maintaining those in an undifferentiated state in prolonged cultures is of immense significance for fundamental research on stem cells. This would serve as a great source in order to explore our own intellectual potential. Scientists at NCCS, Pune (Dr. Lenka); NIRRH, Mumbai (Dr. Bhartiya); NCBS (Dr. Panicker) and JNCASR (Dr. Inamdar), Bangalore; NBRC, Gurgaon (Dr. Mani, Dr. Seth); CDFD, Hyderabad (Dr. Khosla), RGCB, Trivandrum (Dr. James) and the private organization like Reliance Life Sciences, Mumbai, among others, are actively involved in embryonic stem cell research from sources of both murine and human origin. Some of the recently published reports on partially/fully characterized human embryonic stem cell lines (Mandal et al., 2006; Lenka and Ramasamy, 2007; Inamdar et al., 2009; Kumar et al., 2009) indicate the progress accomplished in this direction. Moreover, attempts have also been made at NIRRH, Mumbai (Dr. Bhartiya) to establish somatic cell nuclear transfer (SCNT)/ therapeutic cloning in primates as well as in human species. Further characterization of these reprogrammed cells into various lineages as well as developing strategy for the enrichment and purification of lineage specific stem cells would supplement their clinical relevance in cell replacement therapies in treating various degenerating diseases. The recent revolution in the stem cell arena, the establishment of induced pluripotent stem cells has also been initiated by a couple of groups within the country and will bear fruit as institutional support mechanism work in tandem with enhanced outlay for stem cell research.

Keeping pace with the global thrust, scientists in India are also actively engaged in various aspects of tissue specific stem cell research - fetal and adult origins. While work on neural stem cells is a major focus at NBRC (Dr. Mani), NCCS (Dr. Shastry, Dr. Shiras and Dr. Lenka), NCBS (Dr. Panicker), TIFR (Dr. Tule and Dr. Vaidya), PGI (Dr. Anand) and LVPEI (Dr. Kashyap), the group at CCMB studies stem cell quiescence using skeletal muscle cell lines (Dr. Dhawan). Major strides have been made in the hemato-poietic stem cell research by NCCS (Dr. Kale), Nill (Dr. Mukhopadhyay) and INMAS (Dr. Gurudatta) among others, in basic biology, maintenance, and signaling cues underlying hematopoiesis. More-over, successful endeavour of NCCS scientists (Dr. Limaye) in devising the technology for efficient cryopreservation of umbilical cord blood and bone marrow derived stem cells has resulted in transferring the know-how to nearby hospitals with a view to venturing into therapeutic exploration. In fact, in NCCS alone a number of groups are already pursuing investigations on stem cells from hematopoietic, neural, cardiovascular and pancreatic origin with active collaboration with clinicians. Efforts are also ongoing in understanding the biology and significance of cancer stem cells at NCCS (Dr. Bapat, Dr. Shiras) and IISc. (Dr. Ranga-rajan). The future course will be determined by the pace of integration of nanotechnology and biomaterial scaffold for engineering tissues in a 3D platform, that can also boost interdisciplinary research.

Several research institutions and biotech companies have been formed with the mandate on bringing stem cell research outcomes from bench to bedside. Some of the major medical institutions like PGI, Chandigarh; AIIMS, New Delhi; SGPGI, Lucknow; CMC, Vellore; AFMC, Pune, Manipal Hospital, Bangalore; CLRI, Hyderabad have either already initiated or are in the process of venturing into stem cell transplantations using sources like umbilical cord blood and bone marrow in treating neurological, hematological, hepatic and cardiac disorders. LVPEI, Hyderabad and Shankar Netralaya, Chennai have successfully carried out limbal stem cell transplantations and restoring vision to many. Among the private companies. Reliance life sciences, Mumbai and Stempeutics, Bangalore are the key players in conducting stem cell research and clinical transplantations. Stempeutics, which is a wholly owned subsidiary of India’s Manipal Education and Medical Group (MEMG), has opened its RM20 Million groundbreaking stem cell research facility in Malaysia, leading the way for such research to be conducted in the South East Asian Nation. Another new venture such as FIRST (Foundation for Innovation for Research in Stem Cells and Therapeutics), is being shortly started in Chandigarh, planning to create a new model of partners that involve people from various disciplines.

Incidentally, India is emerging as a clinical hub for stem cell transplantations and with the new law allowing public-private partnership, would let the scientists at public sector create new spin offs and hold equity in private enterprises, eventually setting the pace in favour of stem cell entrepreneurship. However, the flip side is that, a lot of hype has been created with respect to the stem cells therapeutic implications. Though ethical guidelines are in place, these are probably not as restrictive as in some other countries like USA, Germany etc. The patients and caregivers remain ignorant of the status of stem cell therapeutics and are generally lured by certain private clinics which showcase tempting success stories without long term monitoring practice, providing therapy without any regulatory approvals. In addition, the cost effectiveness of treatment in comparison to similar centres in other developed countries has further vitiated the flourishing medical tourism in the country. A major restructuring of research system within medical institutes can set the pace with which the quality of stem cell transplantation will be delivered. Even though the results of Industry-Academia partnership has been dismal, it is virtually absent in medical institutions where the real clinical trials are currently taking place. It is hoped that, the new regulation allowing scientists to start their own scientific enterprises will throw up many entrepreneurs from such institutes rekindling the dormant link between Industry and Academia. This will also lead to regulation of unethical transplantation practices prevalent in some pockets in the country.

Stem cell research is indeed a very challenging area from both basic scientific and clinical perspective. On one hand, it is an expensive area of research involving very high cost of consumables, reagents and equipments, where the role of industry is highly desirable, while on the other hand the research training of clinicians is grossly lacking (there is no viable MD-PhD program), a hurdle that is being attempted to be overcome by establishment of translational research centres. Undoubtedly, some of the groups in India who are working in this area are competing at a global level and can perform even better if prompt policy changes are brought out to remedy this problem. Similarly, although funding is not a major limiting factor, the funding mechanisms of providing grants along with institutional support system needs major restructuring to optimally utilize the current facilities and skilled manpower for national growth. In fact, overcoming challenges that are prevalent in the research environment in medical and research institutions will determine the quality of translational research. A major policy shift in cropping new leaders of research for science management within the medical institutions as well as research organizations are indeed needed in India. This will set the path for acquiring global leadership in stem cell research in this subcontinent.

The measure of success will also be determined by setting standards for the collection, processing and storage of cells intended for clinical use. All cord blood banks would have to be registered with the Drug Controller-General of India (DCGI). The NAC-SCRT (National Apex Committee - Stem Cell Research Therapy) and IC-SCRT (Institutional Committee -Stem Cell Research Therapy) have been constituted as a separate mechanism to address the need for extra vigil and expertise. The National Apex Committee is registering all the stem cell research centers, available stem cell lines in India including the newly developed ones, and ongoing clinical stem cell trials in the country. It will also receive periodic reports from the institutional SCRTs and provide the status of SCRT from time to time. The National Bioethics Committee has prepared the consent for tissue collection for human stem cell research. Thus, the Indian Government is playing a proactive role in guarding research ethics and quality output. The clinician-basic scientist interaction will determine the success of stem cell translation which is steadily coming to fruition with intensive efforts in recent years. Dedicated centres for stem cell research are in the pipeline with multifaceted activities on both basic and applied aspects that could indeed open wider horizon, laying the foundation for a better tomorrow. The scientific community is trying to achieve greater strides in addressing the complex issues in biology that will have implications on medicine of tomorrow. Collective, sincere and dedicated approaches will inevitably help India stand tall in the global stem cell arena.

doi: 10.5214/ans.0972.7531.2009.160301

Nibedita Lenka
National Centre for Cell Science
Pune INDIA

Akshay Anand
Editor-in-Chief

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