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M-20: Analysis of Indian National Guidelines for Stem Cell Research: A Path to Good Clinical Practice and Patient Care.

Poster Presenter

Muntazir Ali Parvez Akhtar Sayed

Medical Student
RCSM Government Medical College; CPR General Hospital
India

Objectives

To review and analyze the updated guidelines for stem cell research published by the Indian Council of Medical Research (ICMR), New Delhi, India with the aim to portray India’s recent scenario of stem cell research and development.

Method

Guidelines for stem cell research published by ICMR in October 2017 were reviewed & analyzed in conjunction with the 2016 guidelines of International Society for Stem Cell Research (ISSCR), US. We conducted a research activity on the bioethical & scientific implications of the new recommendations.

Results

ICMR updated its current guidelines for stem cell research in October 2017 as National Guidelines for Stem Cell Research (NGSCR-2017) which focused on monitoring mechanism and regulatory pathway for basic, clinical research and product development. The need for rigorous clinical trials and regulatory processes to determine whether a proposed treatment is safe, effective and better than existing treatments was highlighted in NGSCR-2017. The guidelines emphasize the ethical principles that should guide human stem cell research, clinical translation, and related research activities. The guidelines take note of the fact that pluripotent stem cells derived from a variety of sources are now easily accessible for clinical trials, often without rationale and hence suitable procedures for their use and handling are required. The issue of human induced pluripotent cells (hIPSC) was first discussed in the ISSCR guidelines in May 2016 with India adopting the same in NGSCR-2017. Apart from challenges of selecting appropriate stem cells for a particular condition, there are important concerns related to the use of embryos for creating human embryonic stem cell lines as these may lead to commoditization of human cells and tissues. The Indian regulatory team has highlighted the challenges related to the contentious issue of human germ-line engineering and reproductive cloning. NGSCR-2017 takes into consideration all these issues including recent developments in germ-line modification. With stem cell biology emerging as an important area of biomedical research with potential applications in developmental biology, disease modeling, tissue engineering, drug development and toxicity testing, use of stem cells in regenerative medicine is a holding promise for improving human health.

Conclusion

Despite the achievement of notable successes, the path to good clinical practice and patient care through stem cell research is still onerous requiring more and more space as well as a targeted support to the pursuit of increasingly ambitious objectives. Research frequently encounters hurdles of ethical and moral nature that oppose the impulses that lead science to the threshold of human limitations. There is an immense need to comply with the updated regulations and of constant progression to knowledge in the area of stem cell research. The most important feature of the latest NGSCR-2017 recommendations is to lay the foundation for the protection of the interests of patients, researchers, and industry in order to ensure a productive collaboration in the field of stem cell research and clinical translation. India has a large unmet medical need, which requires facilitation of safe and regulated translational and clinical stem cell research. The next two years would be very crucial for the nascent stem cell industry in India and thus the new regulations would fuel innovation, research and commercialization in the sector by 2020.