India is the key player in stem cell sector, one of the most exciting research areas of 21st century. Much hyped field is expected to bring new horizons in the field of biology, in general and medicine, in particular. The cells due to their specialized properties of self-renewal, multiplication and differentiation are able to give rise to any kind of a tissue and act as back bone of body’s repair system. The cells have variable differentiation potential depending upon the source of the cells; with early foetal developmental stages (trophoblast) able to give rise all the body cells (pluripotent) followed by limited number of different cells (multipotent/oligopotent) as terminal differentiation occurs. The breakthrough research in stem cell field was made when adult tissue cells were reprogrammed into stem cells known as induced pluripotent stem cells (iPSCs). The potential of the research is seen to the extent that the scientists John B. Gurdon and Shinya Yamanaka were awarded 2012 Nobel prize in medicine.
Stem cell therapies, despite such potential, are still under experimental phases both in medical as well as veterinary practice barring few clinical ailments like leukemia (Haematopoetic SC) or other blood disorders. In man, stem cell therapy has been initiated using stem cells of human origin (autologous), in which human embryos account for 13%, fetus 2%, umblicus 10%, and the major share of 75% is from adult tissues. Teratogenic (tumor forming potential) effect and ethical issues of Embryonic SCs or iPSCs currently restricts their clinical applications. The somatic stem cells like mesenchymal stem cell therapy thus, carry major share of the stem cells in human clinical trials. The cells, however, under current circumstances are mostly limited to early phase clinical trials viz., phase I (40.6%), I/II (26.0%), II/III (22.5%), III (3.8%), III/IV (6.7%), IV (0.3%). Therefore, there is still a long way for stem cell to act as a definitive therapeutic modality.
Despite lack of sufficient scientific and ethical basis, a false hope is raised in patients by claiming efficacy of stem cell treatment for numerous incurable ailments worldwide. Indian clinics are often accused of making false claims and even at times offer fake declarations of approval from governing bodies. The claims are advertised and circulated through internet or proliferative cross border links that attract the stem cell tourism as the patients from west travel to India for the therapy, making governance de-territorial. Indian Medical Council (Professional Conduct, Etiquettes and Ethics) does not permit clinicians such advertising and publicity practices and an action may be initiated against such erring clinicians by MCI or respective State Medical Councils.
To curb such a growing menaces in the field of stem cell therapy, scientific research bodies from different parts of the world formulated guidelines from time to time (ISSCR, 2007; NGSCR, 2007; FDA, 2010; NGSCR, 2013; NGSCR, 2017). In India, the latest guidelines stipulated that clinical use of stem cells is not permitted (except mentioned above or listed in ICMR Guidelines) and that any use of stem cells in clinical contexts must be part of clinical trial duly approved by the concerned committees/authorities. Cord blood banking, although debatable, registered with CDSCO is currently only source approved for stem cell harvesting (Economic Times, 12 Oct, 2017). Despite such stem cell regulations, India is generally claimed as governance vacuum and is attributed to the lack of statutory regulations. All this came as the DCGI didn’t consider stem cell as biological entity but later it was realized that it is a part of schedule Y and thus, comes under biological cell, vaccine or recombinant.
In a recent announcement, union health ministry, GOI has proposed an amendment to the Drugs and Cosmetics Act in order to bring substantial manipulated stem cells and cell-based products under the ambit of the law. Even government has also set up National Apex Committee for Stem Cell Research & Therapy (NAC-SCRT) to oversee and monitor activities in this field. With this announcement the governance vacuum of Indian stem cell sector may finally be addressed by the statutory laws. The clinical trial under which stem cells termed as ‘Investigational New Drug’ or ‘Investigational New Entity’, are regulated by Central Drug Standards Control Organization (CDSCO) and needs prior approval from Drug Control General of India (DCGI). However, autologous stem cell use remains unchecked as Drugs and Cosmetics Act considers the cell as minimal manipulation (Times of India report, Dated: 16 April, 2018).
Currently, no definitive stem cell treatment is available except mentioned by the ICMR guidelines (20 medical conditions in adults and 13 in pediatric). However, patient may avail stem cell therapy as part of clinical trial without being charged. A clinical trial registry India (http://ctri.nic.in/clinicaltrials/login.php) has been established to register the cases in India while various International clinical trial registries may be referred from https://www.hhs.gov/ohrp/international/clinical-trial-registries/index.html. Veterinary field although lack such registries but animal studies are important as the studies may support and add to data on the efficacy and safety of the stem therapy in human medicine vis-à-vis therapeutic development in veterinary practice. Apart from regulatory and statutory laws, patient’s own deliberation into the field is also required. To confirm genuinity, following questions may be asked prior opting the stem cell therapy: 1) Therapeutic center, its certification and recognition; governmental or private; cell source; whether Good Laboratory Practices (GLPs), Good Manufacturing Practices (GMPs) and Good Clinical Practices (GCPs), are being followed or not; Does the center register the undertaken cases in the clinical trial registry?; The results obtained from the clinical studies whether peer reviewed by an independent team set up by national/central regulatory authorities or are self-reviewed; Apart from above mentioned queries, one should consider his/her case whether suitable for the therapy or not, in addition to its results available on different clinical trial registries.
With new statutory laws, it is expected that substantial manipulated stem cell and cell-based products may finally be regulated but still onus lies on the recipients of the therapy
Dr. Mudasir Bashir is Assistant Professor cum Junior Scientist Stem cell Researcher, FVSc & AH- SKUAST Kashmir