There is no treatment regime using Stem Cells
has been established yet, however, treatment using Stem Cell is only valid for
diseases like Cancer. All India Institute of Medical Sciences (AIIMS), New
Delhi, is providing treatment through Stem Cell Therapy to Cancer patients
only.
The Indian Council of Medical Research (ICMR),
in collaboration with the Department of Biotechnology, has prepared the
National Guidelines for Stem Cell Research in the year 2013. These guidelines
apply to all stakeholders including individual researchers, organizations,
sponsors, oversight/regulatory committees and any others associated with both
basic and clinical research on all types of human stem cells and their
derivatives. The details are given below:
Salient
features of the guidelines
National
Guidelines for Stem Cell Research (2013) apply to all stakeholders including
individual researchers, organizations, sponsors, oversight/regulatory
committees and any others associated with both basic and clinical research on
all types of human stem cells and their derivatives. As per the National
Guidelines for Stem Cell Research (2013), an additional layer of oversight,
besides the Institutional Ethics Committee (IEC), in the form of Institutional
Committee for Stem Cell Research (IC-SCR) and National Apex Committee for Stem
Cell Research and Therapy (NAC-SCRT) has been introduced to review and monitor
stem cell research at the institutional as well as the national level. A
National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) will
monitor and oversee activates at national level and institutional Committee for
Stem Cell Research(IC-SCR) at institutional level. These oversight committees
shall ensure that review, approval and monitoring of all research projects in
the field of stem cell research are done rigorously and effectively as per the
National Guidelines. This mechanism of additional review has been accepted by
the scientific community in the country and the NAC-SCRT has become operational
after its notification by Department of Health Research (DHR) on 29th
October 2012. Till date, 82 organizations/ institutes across the country have
applied for registration of their IC-SCRs with NAC-SCRT. Out of which only 5
institute have fulfilled the criteria and have been granted registration. The status
of registration of these organizations is available at NACSCRT website.
Clinical
Research/Trial
Clinical
trials using human stem cells should be in compliance with Schedule Y of Drugs
and Cosmetics Act and GCP Guidelines of CDSCO (www.cdsco.nic.in)as
well as ICMR Ethical Guidelines for Biomedical Research involving Human
Participants (http://www.icmr.nic.in/ethical
guidelines.pdf). Clinical trial protocol shall be
formulated as per the format given in Annexure-II. The clinical research on
stem cells must be performed only by appropriately qualified medical
practitioners and in medical institutions with adequate infrastructure licensed
by appropriate authority as per existing regulations (Clause 7.1). Reagents
used for the derivation of humans ES or iPS cell lines, or expansion/enrichment
of SSCs, for purposes of clinical trials should be of clinical – grade. The
patient information sheet and the informed consent form shall specifically
address:
a) Information
regarding the present status of use of stem cells in the given condition,
experimental nature of the proposed clinical study and its possible short and
long term risks.
b) Information
stating irreversibility of the intervention.
c) Information
regarding source and characteristics of stem cells and degree of their ex-vivo
manipulation, if any.
d) Information
on the established standard of care for a given condition
e) Information
on the sample size and duration of study
f) The
information sheet and the consent form should be approved by IEC and IC-SCR and
the same should be clearly mentioned in these documents.
Regulatory Approvals:-
1.
All
clinical trials using stem cells shall be registered with CTRI http://ctri.nic.in/Clinicaltrials/longin.php
2.
Clinical
trial proposals using minimally manipulated autologous SSCs hall be approved by
IC-SCR and IEC.
As per the Indian Council of Medical Research (ICMR) National
Guidelines for Stem Cell Research (2013), there are no approved indications for
Stem Cell Therapy other than the Hematopoietic Stem Cell Transplantation (HSCT)
for hemological disorders.
The Minister of State (Health and FW), Shri Shripad Yesso Naik stated this in a written reply in the Lok Sabha here today.
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MV/LK