Regulatory Prospects for Stem Cell in Clinical Trials: UAE, US, and India.

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.