In this study, we analyzed current scenario of clinical trials on stem cell as a therapeutic agent in India using the CTRI database. Worldwide, the stem cell treatment considered as a cell-based therapy or simply “stem cell therapy” but in India, it considered as a “drug”. Therefore, the notion of treatment has changed from “therapy” to “drug”. After considering as a drug, the regulatory requirement has also been changed (Qiu et al, 2020).
Using the database of clinical trials several studies have been published on the stem cell therapy using different perspectives. All these studies were conducted using ClinicalTrials.gov and also gathering the data from other international databases (Monsarrat et al, 2016, Fung et al, 2017, Negoro et al 2018, Negoro et al 2019, Deinsberger et al, 2020). Although these studies showed clinical trials conducted in India but scenario of Indian context was limited. Another most important thing is that these all studies used prime source was ClinicalTrials.gov not CTRI database. Our study is solely dependent on the CTRI database with the acceptance of some limitations of this database. Pillamarapu et al, 2019 have described these limitations and many information is not seen or missing on the CTRI database. Similar situation is also found in a study done by Negoro et al, 2018 using ClinicalTrials.gov.
Our study is based on the clinical trials on stem cells registered in CTRI database, the priority being given to interventional types (70%) of trials (Fig. 1). The single armed trials (43%) were mostly used for conducting a trial instead of randomised clinical trials (RCTs) (33%) (Fig. 2). The RCTs have important value in the field of clinical trial field. The study showed Phase 1 clinical trials (43%) and Phase 3, only 9% of the total trials. When focusing on the recruitment status of clinical trials, we found that, majority of clinical trials were in the open to recruitment status (26%). The patient recruitment was completed in only 14% of the trials. The autologous stem cell sources (55%) were slightly higher than the allogenic stem cell sources utilised. That is, the autologous stem cells is more preferred than the allogenic stem cells used during the stem cell therapy (Fig. 5). Among the scrutinised data, we found that, bone marrow was the most favoured stem cell source in this field (Fig. 6).
The Stempeucel® is a product have market authorisation approval. The Stempeutics have gotten the market authorization for Critical Limb Ischemia due to Buerger’s Disease and Critical Limb Ischemia due to Peripheral Arterial Disease from the CDSCO (Stempeutics, 2021). The Stempeucel® is currently under clinical trials for Knee Arthritis, which is now in the Phase 3 (CTRI/2018/09/015785). This drug also applying for the Diabetic Foot Ulcer, which is also in the Phase 3 (CTRI/2019/12/022351). In woman, Asherman syndrome is a rare disease of uterus. AIIMS New Delhi have conducted pilot level clinical trials on this disease, which is now in Phase 4 (CTRI/2013/08/003896). This single arm trial was registered in 2013 and open for recruitment. The future of iPSCs is not clear from this analysis because it has only one registered clinical trial (CTRI/2019/11/022000). This trial is observational type and RCTs not done yet. The hype from iPSC is increased and promoted by the Nobel Prize in 2012. India is far behind in the race for creating and implementing iPSC technology (Lu and Zhao 2013, Deinsberger et al. 2020).
The time required for the product development cannot be concluded from our stduy because of data insufficiency on the CTRI database. Therefore, it is necessary to trace the clinical development of stem cell based therapeutic products from another information sources. The aim of this paper is to show a comprehensive analysis of clinical trials involving stem cell as a therapeutic product in India. Many businesses market “unproven treatments make positive but imprecise and unquantified claims about the therapeutic promise of the stem cell interventions they promote,” explained by Leigh Turner Associate Professor at University of Minnesota Center for Bioethics, School of Public Health and College of Pharmacy (Turner, 2018). Working with stem cell, it arises many ethical, societal, political, and legal issues. Hence each country has attempted to regulate clinical translation of stem cell for the public (Turner, 2018; Berger et al, 2016).
The Indian Government released the National Health Policy 2017. This policy guideline showed very ambitious goals but fail to provide any details of regenerative medicine or stem cell therapy. Therefore, it indirectly affects the all activities related to stem cell based drug development process. Department of Biotechnology have recently released second strategy statement on the development of biotechnology in India i.e. National Biotechnology Development Strategy 2021–2025. It ensure about helping development of future medicine including regenerative medicine or stem cell therapy. The draft on the Science, Technology, and Innovation Policy 2020 has been released by Department of Science and Technology. This draft shows promise for development and promotion of future medicine. The Indian government aims to promote the stem cell research and therapy through clinical trials then in future, India will be a real and an affordable destination for the “stem cell tourism”.