In October 2017, the Indian Council of Medical Research (ICMR) released the National Guidelines for Stem Cell Research1. The National Guidelines for Stem Cell Research, 2017, is an outcome of concerted efforts of different stakeholders. It has been formulated taking into account several new scientific and technical advancements as well as the perceived challenges in the field. Efforts were made to bring together all concerned ministries/ agencies to chalk out strategies to curb rampant unethical practices in banking and therapeutic applications.
The guideline reiterates that any stem cell usage in patients, other than that for hematopoietic stem cell reconstitution for approved indications, is investigational at present. Accordingly, any stem cell use in patients must only be done within the purview of an approved and monitored clinical trial with the intent to advance science and medicine, and not for offering it as therapy. In accordance with this stringent definition, any use of stem cells in patients outside an approved clinical trial is unethical and shall be considered as malpractice.
Some major amendments in this guideline include: mandatory registration of Institutional Committee for Stem Cell Research (ICSCR) and Institutional Ethics Committee (IEC) with National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) and CDSCO respectively; undertaking clinical trials only at institutes with registered IC-SCR, IEC, and only at Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) certified facilities; research undertaken by medical professionals registered with the Medical Council Of India (MCI) having an MCI approved post graduate qualification in the domain area of the specific trial.
These guidelines are applicable to all stakeholders including individual researchers, organizations, sponsors, oversight/regulatory committees and all others associated with both basic and clinical research involving any kind of human stem cells and their derivatives.
ICMR's guidelines states that sponsors must gain approval from the Central Drugs Standard Control Organization (CDSCO) before starting clinical trials of stem cells. Trials can only take place at registered Institutional Committee for Stem Cell Research and under the oversight of medical professionals registered with the Medical Council of India. These rules apply to all stem cell trials. ICMR has also introduced tiered regulatory requirements tied to the level of manipulation performed on the stem cells. Cells that undergo genetic modifications are subject to different regulatory requirements than those that are used in a form close to their natural state.
ICMR has found no scientific evidence "to substantiate clinical benefits with the use of stem cells derived from cord tissue, placenta, tooth extract, adipose tissue, dental pulp, menstrual blood and olfactory ensheathing cells." Given Indian companies' offers to bank these materials, ICMR is concerned about the "exploitation and commoditization of the resources."
As of now, CDSCO only permits and licenses umbilical cord banking. A list of approved indications for Hematopoietic Stem Cell Transplantation (HSCT) has also been provided as an annexure in the guideline. The guideline lists 20 types of indications (diseases) for adults and another 13 categories of indications for children below 18 years, where stem cell treatment is approved.
Accordingly, commercial banking of all other biological materials is not permitted until further notification. ICMR wants the regulator to enforce this rule.
Banking of Umbilical Cord Blood (UCB)
The guideline says that UCB is a rich source of CD34+ hematopoietic and mesenchymal (stromal) stem cells. Use of UCB derived Hematopoietic Stem Cells (HSCs) for treatment of various haematological and immunological disorders is currently well established, particularly where an HLA-matched sibling is not available. However, there is a paucity of public funded UCB banks in India. On the other hand several private banks have come-up, that engage themselves in promotional advertising offering storage of cord blood with the promise of future therapeutic use. Such advertisements are often misleading for the public and lack comprehensive and accurate information. So far there is no scientific basis for preservation of cord blood for future self-use and this practice therefore raises ethical and social concerns.
Publicity and Advertisements in Media
The guideline also states that the advertising and publicity through any mode is not permitted. It may be noted that actions can be taken against the erring clinicians/entities under existing rules and regulations of Medical Council of India, The Drugs and Magical Remedies (The Objectionable Advertisements) Act- 1954, Advertisement of treatment of several diseases as listed in Schedule J of Drugs and Cosmetics Act, 1940 and rules therein, and any advertisement that violates the code for self regulation in advertising, as adopted by the Advertising Standards Council of India (ASCI).
Conclusion:
The 2017 guidelines, reiterate that any stem cell use in patients, other than that for hematopoietic stem cell reconstitution for approved indications, is investigational at present. Accordingly, any stem cell use in patients must only be carried out within the purview of an approved and monitored clinical trial with the intent to advance science and medicine, and not as offering it as therapy.
Footnote
1. http://icmr.nic.in/guidelines/Guidelines_for_stem_cell_research_2017.pdf
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