Challenges faced for undertaking a stem cell based clinical trial in spinal cord injury in emerging countries

Abstract

Repair and regeneration after spinal cord injury (SCI) is an unmet need and research into finding new avenues to achieve this are ongoing worldwide. Stem cells with their immense potential to proliferate and differentiate have been identified as prime candidates for spinal cord regeneration. Pre-clinical data on their efficacy has been very encouraging, especially in case of adult stem cells. Although clinical translation of these findings has not been so successful, due to the ease of obtaining autologous adult bone marrow stem cells and their perceived therapeutic potential, these cells have been offered as a “therapy” in many countries without any scientific evidence generated though a valid clinical trial. In this review, we attempt to highlight the need for conducting clinical trials and the challenges faced in case of emerging countries. The current scenario of regulations governing the use of stem cells in emerging countries is also discussed.

Keywords

stem cells / emerging countries / spinal cord injury (SCI) / regulations / clinical trial