STEM CELL

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Stem Cell Research and Regulatory Issues in India

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BY AMIT K. KHAIRNAR INSTITUTE OF PHARMACEUTICAL EDUCATION, BORADI-425 428 (M.S) INDIA Stem Cell Research and Regulatory Issues in India

Points to be covered in Presentation: : 

Points to be covered in Presentation: What are Stem Cells? History of Stem Cell Possible use of Stem Cell Technology Current status in India Question and Problems about Stem Cell Conclusion References

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On August 9, 2001, one month before the 9/11 attacks on New York City and Washington, D.C., President George W. Bush addressed the nation on prime-time television to outline his administration’s embryonic stem cell policy. In his speech, the President declared that the federal government would only fund research with embryonic stem cells that had been made prior to the date of his prime-time address to the nation. This policy specifically, and embryonic stem cell research more generally, has generated much moral and political controversy that continues to this day. What are embryonic stem cells, why are they so exciting and yet controversial, and what can be done to move our society beyond the current moral and political impasse? To provide answers to these questions, we will begin with a very basic introduction to the science behind stem cell research.   What is a stem cell? A stem cell is a relatively unspecialized cell that, when it divides, can do two things: make another cell like itself, or make any of a number of cells with more specialized functions. For example, just one kind of stem cell in our blood can make new red blood cells, or white blood cells, or other kinds—depending on what the body needs. These cells are like the stem of a plant that spreads out in different directions as it grows.1 Stem cells can be classified into three broad categories, based on their ability to differentiate. Totipotent stem cells are found only in early embryos. Each cell can form a complete organism (e.g., identical twins). Pluripotent stem cells exist in the undifferentiated inner cell mass of the blastocyst and can form any of the over 200 different cell types found in the body. Multipotent stem cells are derived from fetal tissue, cord blood and adult stem cells.

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Although their ability to differentiate is more limited than pluripotent stem cells, they already have a track record of success in cell-based therapies. Here is a current list of the sources of stem cells: Embryonic stem cells - are harvested from the inner cell mass of the blastocyst seven to ten days after fertilization. Fetal stem cells - are taken from the germline tissues that will make up the gonads of aborted fetuses. Umbilical cord stem cells - Umbilical cord blood contains stem cells similar to those found in bone marrow. Placenta derived stem cells - up to ten times as many stem cells can be harvested from a placenta as from cord blood. Adult stem cells - Many adult tissues contain stem cells that can be isolated.

Stages of Embryogenesis : 

Stages of Embryogenesis

History of Stem Cell : 

History of Stem Cell Adult stem cell research on humans began in the 1960's, first achieving success in the treatment of a patient with severe combined immunodeficiency disorder in 1968. Since the early 1970's, adult stem cells have been successfully used for treatment of immunodeficiencies and leukemias. Cloning of non-mammals was first accomplished in 1952. However, cloning of mammals proved much more difficult, with the first successful clone being the sheep, Dolly. Dolly died a premature death, probably due to the use of aged chromosomes in her nuclear transfer. Other mammal species followed rapidly, with mice and cows being cloned in 1998, and pigs in 2000. In 1998, James Thomson (University of Wisconsin-Madison) isolated cells from the inner cell mass of the early embryo, and developed the first human embryonic stem cell lines. In 1998, John Gearhart (Johns Hopkins University) derived human embryonic germ cells from cells in fetal gonadal tissue (primordial germ cells). Pluripotent stem cell “lines” were developed from both sources

Possible use of Stem Cell : 

Possible use of Stem Cell In theory, stem cell technology could be used to produce replaceable tissues or organs. Defective tissues/organs could be repaired using healthy cells. It would also be possible to genetically engineer stem cells to accomplish activities that they would not ordinarily be programmed to do. Part of this engineering could involve the delivery of chemotherapeutic agents for treatment of cancers and tumors. Adult stem cells have shown great promise in many published studies. These cells have shown the potential to form many different kinds of cell types and tissues, including functional hepatocyte-like (liver) cells. Such cells might be useful in repairing organs ravaged by diseases. Stem cells may help to treat disorders arising from tissue destruction. Juvenile diabetes is a disorder in which insulin-producing cells in the pancreas have been destroyed. If these cells could be produced from stem cells and transferred to the patient, the disorder could be cured. Stem cells have been used to study Parkinson’s disease and its treatment.

Current status in India : 

Current status in India Stem cell biology is a promising and emerging field of the life sciences. The potential of stem cell technology to develop therapy for many untreatable diseases through cellular replacement or tissue engineering is widely recognized. Keeping in view its potential therapeutic applications, both basic and translational research are being promoted by the Department in various institutions, hospitals and the industry. Till date, more than 55 programmes have been identified and supported on various aspects of stem cell research.  'Soon, We would have a Law on Stem Cell Research‘- Geeta Jotwani (Programme Officer-Stem Cell Research, ICMR) Due to ethical and religious dogmas enshrouding research with human embryos, the Indian Government has decided to come clear on the scope and purview of stem cell research in the country. Following the request from Drug Controller General of India (DCGI) in 2009, the Indian Council of Medical Research (ICMR) jointly with Department of Biotechnology, has recently further expanded the draft guidelines for stem cell research, incorporating the technical issues involved in embryo research.

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Regulatory authorities in India have, for the first time, given the green light for clinical trials to test stem-cell products. Sponsored by Stempeutics, those trials will test mesenchymal stem cells in patients who with critical limb ischemia or who have had heart attacks. Like a handful of other trials, these cells will be derived from the bone marrow of healthy donors, processed or expanded in vitro, and injected into diseased patients.

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ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI National Institute for Research in Reproductive Health (ICMR), Mumbai National Center for Cell Science, Pune Rajiv Gandhi Center for Biotechnology Trivandrum , Kerala, India Center for Cellular and Molecular Biology, Hyderabad The Stem Cell Institute (SCSRM) Center for Cellular and Molecular Platforms

Question and Problem : 

Question and Problem In order to be used clinically, human embryonic stem cells must be differentiated prior to use in patients. Undifferentiated stem cells could produce tumors and multiply unchecked within a patient, causing more problems than providing appropriate therapy. It is uncertain if conditions can be defined such that all embryonic stem cells differentiate into the correct cell type prior to therapeutic use. Complications caused by undifferentiated cells might not be discovered until years after the first clinical trials are begun. "Scientists are still working on developing proper conditions to differentiate embryonic stem cells into specialized cells. As embryonic stem cells grow very fast, scientists must be very careful in fully differentiating them into specialized cells. Otherwise, any remaining embryonic stem cells can grow uncontrolled and form tumors."7 Recently, three established stem cell lines were shown to exhibit abnormalities in chromosome number and structure.4,5 Obviously, stem cell lines must be checked periodically to make sure the cells do not become abnormal during continued culture. The use of abnormal cells in treatment of patients could result in indeterminate complications.

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Harvard scientists reported in the Proceedings of the National Academy of Sciences that five out of the 19 mice injected with embryonic stem cells developed tumors and died."8 Stem cell lines will suffer the same tissue rejection problems as adult transplants. Once differentiated, these cells will express the HLA tissue antigens programmed by their parental DNA. “Within the [embryonic stem cell] research community, realism has overtaken early euphoria as scientists realize the difficulty of harnessing ESCs safely and effectively for clinical applications. Research continued to highlight the tasks that lie ahead in steering cell differentiation and avoiding side effects, such as immune rejection and tumorigenesis.”7

Conclusion : 

Conclusion Stem cells show great promise for regenerative medicine. ES cells proliferate indefinitely in culture and are pluripotent; some adult stem cell lines show unexpected plasticity and proliferative powers. Research on both adult and ES cells should be pursued. Countries that allow strictly regulated research on early human embryos will also allow ES cells to be made from ‘spare’ embryos donated by couples in IVF clinics. Stem cells from cloned embryos are unlikely to be useful in routine clinical practice, but could be valuable for research on rare genetic diseases, and common diseases of complex origin. For all stem cell therapeutic applications, it is important to keep in mind considerations of risk-benefit. The most important plea, however, is that scientist, doctors and the media should beware of raising patients’ hopes unduly, since clinical trials using human embryonic stem cells in relation to many of the diseases listed previously may well not be attempted within the next 10– 20 years. Premature clinical application would be most undesirable, both for the patients and for the future of stem cell therapy in general.

References : 

References Owen RD. Immunogenetic consequences of vascular anastomoses between bovine twins. Science. 1945;102:400-401. David A. Prentice. 2004. Monitoring Stem Cell Research (www.bioethics.gov) Appendix K. “Adult Stem Cells”. Ethical Issues in Human Stem Cell Research, Volume 1: Report and Recommendations of the National Bioethics Advisory Commission, 1999. "Frequently Asked Questions." International Society for Stem Cell Research. Draper, J.S., et al., "Recurrent gain of chromosomes 17q and 12 in cultured human embryonic stem cells," Nature Biotechnology December 7, 2003, advance online publication. C. Cowan et al. 2004. Derivation of Embryonic Stem-Cell Lines from Human Blastocysts. New England Journal of Medicine 350: 1353-1356. E. Phimister and J. Drazen. 2004. Two Fillips for Human Embryonic Stem Cells.” New England Journal of Medicine 350: 1351-1352. Bjorklund, L. M., R. Sanchez-Pernaute, et al. 2002 "Embryonic stem cells develop into functional dopaminergic neurons after transplantation in a Parkinson rat model." Proceedings of the National Academy of Sciences 99: 2344-2349. Hunter, Philip. 2003. Differentiating Hope from Embryonic Stem Cells. The Scientist 17: 31.

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HEALTHY AND GREEN EARTH IS DREAM OF 2020 THANK YOU!