Table 1.
Overview of National Guidelines for Stem Cell Research 2017
| Section (s) | Highlights |
|---|---|
| Ethical Consideration (Section 4.1) | Mandatory video consent (as per CDSCO guidelines dated January 19, 2014 - Schedule Y). Screening for 6 major transmittable diseases (HIV-1 and 2, HBV, HCV, Treponema pallidum, HTLV, CMV). Banking of donated material under exceptional circumstances. IPR of donated material will not vest with donor, but may be shared. If commercialization brings any financial benefit, may be passed on to donor/community |
| Scientific Consideration (Section 4.2) | Mandates requirement of appropriate safety measures to mitigate the risk of acquired mutation in PSCs. Short-term and long-term viability/potency testing of cryopreserved or stored products. CDSCO certified GLP and GMP facility (Schedule L1 and M) to process SCPD. For preclinical studies on animals, laboratory should have GLP certification from the DST. Institutional NABL accreditation mandatory, when processing SCPD for human use |
| Levels of Manipulation (Section 7) | 3 levels: 'Minimal' Processing period must be within 72 h; approvals from CDSCO, IC-SCR and IEC; 'Substantial': CDSCO approval only after IC-SCR and IEC clearances; 'Major': CDSCO approval after clearances from NAC-SCRT through IC-SCR and IEC |
| Categorization of Research (Section 8) | 3 categories: “Permissible” - Research involving establishment of ESC and iPSCs; “Restrictive” - Research involving human preimplantation embryos processed by in IVF/LCSI/SCNT to derive ESC lines; “Prohibited” - Research involving human germline gene therapy and reproductive cloning |
| Basic Research (Section 10) | In vitro studies (largely under “permissible” category) require prior approval of IEC and IC-SCR, except studies involving established human stem-cell lines registered with the IC-SCR. In vitro studies on preimplantation human embryos must be carried out within 14 days of fertilization or formation of primitive streak, whichever is earlier. Derivation of new ESC or iPSC lines from human embryonic or somatic cells, respectively, must have prior approval of IC-SCR and IEC. Uterine implantation (human/animal) of manipulated cells with the intent of developing a whole organism is prohibited |
| Translational Research Including Clinical Trials (Section 11) | Preclinical testing: Requires approval from IEC (humans), IAEC (small animals), and CPCSEA (large/nonhuman primates). Product testing must include safety, biodistribution, immune rejection studies, single- and repeated-dose toxicity studies, tumorigenicity, genotoxicity, developmental toxicity studies, and biodistribution studies. Clinical studies: Require clearances from IC-SCR, IEC, and CDSCO, and must be registered with CTRI. Follow-up period of minimum 2 years is mandatory. Establishing DSMB is mandatory for each study. All adverse events must be reported to IEC, CDSCO, NAC-SCRT through IC-SCR. Trial records must be maintained for minimum of 15 years. Patient confidentiality is to be maintained by all means |
| Banking (Section 14) | Banking of UCB or ESC/iPSC lines permitted only in institutions licensed by CDSCO. Commercial banking of all other biological materials not permitted yet. Such banks, if involved in stem cell research, must constitute IC-SCR (NAC-SCRT registered), and have an SOP for banking and release. Biological materials can only be released to institutes with registered IC-SCR and IEC |
| Procurement (Section 15) | IEC and IC-SCR shall review and approve process of procurement. If cells/tissues have been developed utilizing IVF method, clearance from the NAC-SCR mandatory. Archival period for stem-cell lines and related information is 10 years. For procurement of fetal or placental tissue, processes must comply with all obligations under the MTP Act, 1971. The medical person responsible for patient care of and the investigator using the fetal material shall not be the same. The consent for fetal tissue donation should be obtained in advance and not just before or at the time of the procedure. If there is disagreement between parents, the mother’s wish shall prevail. Consent for donation of blastocysts for establishment of human ESC lines should be obtained from the donor at least 24 hours in advance. Donors retain the right to withdraw consent until the blastocysts are actually used in cell line derivation |
| Exchange (Section 17) | Import of stem-cell lines for basic research will not require no objection certificate, but those required for clinical trials and originating oversees require import clearance from CDSCO. For export of indigenously developed cell lines, IEC and IC-SCR clearances must be obtained and submitted along with the MTA during the review of such research proposals |
| Publicity (Section 19) | The advertising and publicity of any kind through any mode are not permitted and is a prosecutable offense |
HIV=Human immunodeficiency virus, HBV=Hepatitis B virus, HCV=Hepatitis C virus, HTLV=Human T-lymphotropic virus, CMV=Cytomegalovirus, IEC=Institutional ethics committee, IC-SCR=Institutional Committee for Stem Cell Research, NAC-SCRT=National Apex Committee for Stem Cell Research and Therapy, GMP=Good Manufacturing Practice, GLP=Good Laboratory Practice, SOP=Standard operating procedure, ESC=Embryonic stem cell, iPSC=Induced pluripotent stem cells, NABL=National Accreditation Board for Testing and Calibration, PSC=Pleuripotent stem cells, SCPD=Stem cell products and derivatives, CDSCO=Central Drugs Standard Control Organization, HSC=Human stem-cell lines, UCB=Umbilical cord blood, MTA=Material transfer agreement, IVF=In vitro fertilization, ICSI=Intracytoplasmic sperm injection, SCNT=Somatic cell nuclear transfer, CTRI=Clinical Trial Registry of India, DSMB=Data Safety Monitoring Board, IPR=Intellectual Property Rights