Thamirabarani, an eight-year old little girl from Coimbatore was suffering from Thalassemia, a blood-related disorder. The cure came in the form of her younger brother Pugazhendi. When her younger sibling was born, his umbilical cord stem cells were collected and preserved at LifeCell. His stem cells were used for Thamirabarani’s treatment of Thalassemia. Now, Thamirabarani is cured permanently of her ailment. Thamirabrani’s stem cell transplant is claimed as the nation’s first successful umbilical cord stem cell transplant for Thalassemia, using sibling’s umbilical cord stem cells. She is back in her school now, spreading her smiles among her classmates and is studying to become a teacher in the future.
Stem cells have been extensively studied in India since the 1960s. The tremendous opportunities that stem cells have provided in the treatment of diseases that were conventionally considered ‘incurable, degenerative and irreversible’ such as diabetes, neurological disorders, cardiac diseases, Alzheimer’s and Parkinson’s is noteworthy. The basic types of stem cells that are studied are neural stem cells, embryonic stem cells, mesenchymal stem cells, and bone marrow hematopoietic stem cells.
According to ICMR, the stem cell therapy market was worth Rs. 1 billion in 2013 and it is expected to reach Rs. 2 billion by the year 2018. India is expected to witness more rise in the number of stem cell depositors in near future. Mayur Abhaya Srisrimal, Chief Executive Officer & Managing Director, LifeCell adds, “Stem cells act as the repair system of the body and have the ability to treat over 80 medical conditions including leukaemia, thalassemia, lymphoma etc. In addition to this, these are also being used in many clinical trials that are checking their potential to treat conditions such as diabetes, autism, stroke, hearing loss etc.”
What are Stem Cells?
Stem-cells are types of cells that have the capability to proliferate themselves through self-renewal and to produce specialised mature cells of a particular tissue through differentiation. Usually, these kind of cells come from two main sources. Adult tissues and embryos formed during the blastocyst phase of embryological development (embryonic stem cells). Such cells are either derived from a mature tissue or from a dividing zygote in a culture dish. Once scientists extract these out, they place these cells in vitrio conditions that prohibit them from further specialising but just allows them to replicate.
As compared to the process of growing adult stem cells, producing embryonic stem cells is easier. Dr. Surveen Ghumman Sindhu, Director & Head, IVF and Reproductive Medicine Unit, Max Healthcare reclaims, “There are embryonic stem cells which can be generated from the embryos which are not in use. That is where IVF is related to stem cells. Stem cells can generate a sperm, it can generate an ovum, and even a human being. Hence, this kind of research needs strict regulations.”
Ethical Issues Surrounding Embryonic Stem Cell Research
The relationship between the generation and supply of embryos for hESC((human embryonic stem cell) research and cultural context surrounding it is complex. India’s IVF clinic the ideal destination of embryos to which scientists from all across the world come for supplies. However, after setting up of ESC line research National Centre of Biological Sciences and Reliance Life Sciences Laboratory in 2001, a government made stringent norms for clinical research to counter the international view of India as ‘an embryo surplus’ nation.
Dr. Ritika Sahay Shukla, Director, India IVF clinic opines, “In stem cell transplant there are usually three kinds of procedures. First is the allogenic kind of transplant in which we take stem cells from one individual and put them in another. Second is autologous in which we take stem cells from the patient and transplanting them in the same patient. The third kind of transplant is xenogenic in which we take stem cells from animal species and then transplant it. So, this has to be stringently regulated because there are researches in China where they have used a material called ‘abortus’ for pancreas which requires highest level of sensitivity and regulatory mechanism.”
Regulations for Research in India
The recent ethical guidelines for biomedical research were published by the Indian Council for Medical Research (ICMR) in 2017. The section 4 of ‘National Guidelines for Stem Cell Research’ clearly states that cells and tissues extracted from human foetuses, embryos or any other sources must safeguard safety, dignity, and human rights. This also includes procedures such as clinical trials and diagnosis involving human tissues or cells.
Mr Mayur Abhaya, MD & CEO, LifeCell further adds, “There are currently 500+ ongoing clinical trials and many of them in advanced stages, set to become routine treatments in the near future. According to the recent guidelines of ICMR, these treatments cannot be commercialized and must be carried out only as registered trials with prior authorization. But patients who have an urgent need today and have exhausted all alternative options are seeking unapproved access to such experimental treatments.”
Institutions to Apply for Stem Cell Research
Several institutes in India offer post-graduate courses in this field of medicine. Some of such institutes are National Centre for Biological Science (NCBS), Bengaluru; Indian Institute of Science, Bengaluru; National Centre for Cell Science (NCCS), Pune; Manipal Institute of Regenerative Medicine (MIRM), Bengaluru; National institute for Research in Reproductive Health, Mumbai; Centre for Cellular and Molecular Biology (CCMB) Hyderabad; and Indian Institute of Technology, Madras. Dr Asmita Das, Assistant Professor, Biotechnology Department, Delhi Technological University suggests, “There are exemplary labs in IISc along with some good private institutes which are working on stem-cell research in accordance with the stringent measures suggested by ICMR.”
Minimum eligibility for a post-graduate programme in stem-cell and tissue engineering is 50% marks or equivalent CGPA in a bachelor’s programme in Biological Sciences, Biotechnology and Informational, any branch of Life Sciences, Pharmaceutical Sciences, Chemical Sciences or equivalent. The specific requirements for each institute can be viewed on its official website.
Steps to Encourage Stem Cell Research in India
Basic research in stem cells in India is carried out by laboratories funded by the government. These laboratories are supported by various agencies such as the Council for Scientific and Industrial Research (CSIR), Department of Biotechnology (DBT), the Indian Council of Medical Research (ICMR), the Department of Science &Technology (DST) etc.
DBT plays a major role for research activities by providing them funding every year. “Researchers in fields like immunology and stem-cell research are working independently. Their research can only actualise when there is a collaboration between researchers and clinicians. Therefore, we need to generate more interaction with clinicians. Only then, these researches will come into deliverable stage”, concludes Dr Ashmita Das.