Good Clinical Practice: A Question & Answer Reference Guide - May 2014 - 620

GCP: A Question & Answer Reference Guide
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Q. What are the regulatory requirements for conducting a CT with stem cells or stem cell-based products
in India?

A. Stem cell research holds great promise for improving human health by restoring cellular and organ function
damaged by degeneration and various injuries. At the same time it also raises several scientific, ethical and social
issues in the development of such applications. ICMR and DBT had released guidelines for Stem Cell Research
in 2007 and as recently as February 2014, addressing ethical and scientific concerns. These guidelines have
categorized research on stem cells into three areas: permissible (with adult stem cells), restrictive (with embryonic
stem cells) and prohibited (therapeutic cloning). Under the permissible category, CTs with clinical grade stem cells
may be carried out in compliance with ICMR Guidelines for Biomedical Research and GCP guidelines, after prior
approval from the Institutional Committee for Stem Cell Research and Therapy (IC-SCRT), Institutional Ethics
Committee (IEC) and DCGI.18 As per the guideline there is no approved indication for stem cell therapy as a part of
routine medical practice, other than bone marrow transplantation (BMT). Accordingly, all stem cell therapy other
than BMT shall be treated as experimental and should be conducted only as CTs after obtaining approval from the
DCGI's office. This applies to both autologous and allogeneic CTs.
DCGI has formed another committee (CBBTDEC) to review CTs proposals on stem cells.. In June 2013,
MoHFW set up a "High powered committee" to suggest a roadmap for regulation of stem cells and other cell based
therapies being practiced in India. The committee, after several deliberations, submitted its report to MoHFW. As
per the recommendations of the committee, CDSCO released draft guidance documentation on 30th December
2013 for regulating stem cell and cell based products (SCCPs) for therapeutic use.19 All activities related to their
usage, i.e., isolation/ collection, manufacture, storage and transplantation into patients must be done under a
license that would be granted from CDSCO. The clinical development plan should include PD studies; PK studies;
mechanism of action studies; dose finding studies and randomized CTs. For demonstration of "proof of principle"
and the choice of clinically meaningful endpoints for safety and efficacy evaluation, relevant nonclinical studies,
previously reported clinical experience of the treated pathology could be used as supportive evidence.
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Q. What are the guidelines for conducting studies in special population groups in India such as pregnant
or nursing women, children and vulnerable groups?

1. Pregnant or nursing women: As a general rule, pregnant or nursing women should not be included as
subjects in CTs, except in trials that are designed to protect or advance the health of pregnant or nursing women or
fetuses or nursing infants, and for which women who are not pregnant or nursing would not be suitable subjects.
The justification for the participation of these women in CTs is so they are not deprived arbitrarily of the
opportunity to benefit from investigations, drugs, vaccines or other agents that promise therapeutic or preventive
benefits. Examples of such trials include studies to test the efficacy and safety of a drug for reducing perinatal
transmission of HIV infection from mother to child, and trials for detecting fetal abnormalities and for conditions
associated with or aggravated by pregnancy. Women should not be encouraged to discontinue nursing for the sake
of participation in research and, if a woman decides to do so, harm due to cessation of breast feeding to the nursing
child should be properly assessed except in those studies where breast feeding is harmful to the infant.
Research related to termination of pregnancy: Pregnant women who seek to undergo Medical Termination of
Pregnancy (MTP) could be made subjects for such research as per The Medical Termination of Pregnancy Act,
Government of India, 1971.
Research related to pre-natal diagnostic techniques: In pregnant women, such research should be limited to
detecting fetal abnormalities or genetic disorders as per the Prenatal Diagnostic Techniques (Regulation and
Prevention of Misuse) Act, and not for determination the fetus's gender.
2. Children: Before undertaking CTs in children, the investigator must ensure that:
* Children will not be involved in research that could be carried out equally well with adults;
* The purpose of the research is to obtain knowledge relevant to the health needs of children;
* A parent or legal guardian of each child has given proxy consent;
* The assent of the child should be obtained to the extent of the child's capabilities (e.g., mature minors,
adolescents);

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