Academic Journal
Regulatory Prospects for Stem Cell in Clinical Trials: UAE, US, and India.
| Τίτλος: | Regulatory Prospects for Stem Cell in Clinical Trials: UAE, US, and India. |
|---|---|
| Συγγραφείς: | Reddy SP; Department of Pharmaceutics, JSS College of Pharmacy, Mysuru, Karnataka, 570016, India., Mishra S; Department of Pharmaceutics, JSS College of Pharmacy, Mysuru, Karnataka, 570016, India., Venkatesh MP; Department of Pharmaceutics, JSS College of Pharmacy, Mysuru, Karnataka, 570016, India.; Faculty of Pharmaceutical Sciences, UCSI University, Malaysia. |
| Πηγή: | Current stem cell research & therapy [Curr Stem Cell Res Ther] 2026; Vol. 21 (4), pp. 249-263. |
| Τύπος έκδοσης: | Journal Article; Review |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: Bentham Science Publishers Country of Publication: United Arab Emirates NLM ID: 101272517 Publication Model: Print Cited Medium: Internet ISSN: 2212-3946 (Electronic) Linking ISSN: 1574888X NLM ISO Abbreviation: Curr Stem Cell Res Ther Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: Saif Zone, Sharjah, U.A.E. ; San Francisco, CA : Bentham Science Publishers, c2006- |
| Ιατρικοί όροι (MeSH): | Clinical Trials as Topic*/legislation & jurisprudence , Stem Cell Research*/legislation & jurisprudence , Stem Cell Research*/ethics , Stem Cells*/cytology , Stem Cell Transplantation*/legislation & jurisprudence, Humans ; India ; United States ; United Arab Emirates |
| Περίληψη: | Introduction: Stem cell therapies are advancing rapidly, requiring robust regulations to ensure safety and ethics. The UAE, with authorities like MOHAP, DOH, DHA, and DHCR, is actively involved in clinical research but faces regulatory inconsistencies across emirates. In contrast, the U.S. (FDA, NIH) and India (CDSCO, ICMR) have unified national frameworks with specific stem cell guidelines. This study compares the UAE's system with those of the U.S. and India to identify strengths and gaps. Methods: A comparative literature review was conducted using regulatory documents, clinical trial registries, peer-reviewed studies, and interviews. The focus was on analyzing the regulatory frameworks in the UAE, the U.S., and India, especially regarding stem cell clinical research. Results: The UAE has established ethical review boards and oversight mechanisms but lacks unified national guidelines and consistent application across emirates. In comparison, the U.S. and India have more cohesive, transparent, and accessible regulatory systems for stem cell research. Discussion: The UAE's efforts in promoting stem cell research are notable, but fragmentation among regulatory authorities hampers coordination. Adopting centralized policies, like in the U.S. and India, could improve efficiency, transparency, and compliance. A national registry and stem cell-specific guidelines are also needed. Conclusion: The UAE has made commendable progress in regulating stem cell clinical research. However, the absence of unified national guidelines and inter-emirate coordination remains a challenge. Learning from the centralized frameworks of the U.S. and India can help bridge these gaps. Strengthening oversight will enhance patient safety, ethical compliance, and global collaboration. (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.) |
| Contributed Indexing: | Keywords: Clinical research; good clinical practice (GCP); regulatory framework; research ethics. robust regulations; stem cell therapy |
| Entry Date(s): | Date Created: 20250905 Date Completed: 20261006 Latest Revision: 20261006 |
| Update Code: | 20261006 |
| DOI: | 10.2174/011574888X372893250804112424 |
| PMID: | 40910248 |
| Βάση Δεδομένων: | MEDLINE |
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