Lok Sabha Question No. 2528 (UNSTARRED), answered on 2016-03-11
Subject: Stem Cell Therapy
Ministry: HEALTH AND FAMILY WELFARE
Asked by: LAKHAN LAL SAHU

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH RESEARCH

## LOK SABHA UNSTARRED QUESTION NO. 2528

## TH

## TO BE ANSWERED ON 11 MARCH, 2016 STEM CELL THERAPY

## 2528. SHRI LAKHAN LAL SAHU:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

- (a) whether the treatment through stem cell has been started in the country and if so, the details thereof;
- (b) the details of the hospitals in the country providing treatment through stem cell therapy; and
- (c)  the details  of  the  guidelines  prepared/ issu by  the  Government  to  give permission  for starting stem cell research and treatment in the country?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI SHRIPAD YESSO NAIK )

(a )to(c): 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 o Sciences  (AIIMS),  New  Delhi,  is  providing  treatment  through  Stem  Cell  Therapy  to  C ancer patients only.

The Indian Council of Medical Research (ICMR), in collaboration with the Departmen of Biotechnology, has prepared the National Guidelines for Stem Cell Research in the year These  guidelines  apply  to  all  stakeholders  including  individual  researchers, organizations, sponsors, oversight/regulatory committees and any others associated with both basic and c research on all types of human stem cells and their derivatives. The details are at Annexure .

As per the Indian Council of Medical Research (IC MR) National Guidelines for Stem Cell Research (2013), there are no approved indications for Stem Cell Therapy other th Hematopoietic Stem Cell Transplantation (HSCT) for hemological disorders.

## 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  (NACSCRT)  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  29 th 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.
- c) Information  regarding  source  and  characteristics  of  stem  cells  and  degree  of their ex-vivo manipulation, if any.
- b) Information stating irreversibility of the intervention.
- d) Information on the established standard of care for a given condition
- f) The information sheet and the consent form should be approved by IEC and ICSCR and the same should be clearly mentioned in these documents.
- e) Information on the sample size and duration of study

## 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.