The therapeutic promise of Mesenchymal Stem Cells has generated an explosion of research activity, resulting in over 1,100 registered Clinical Trials worldwide. These trials span a diverse range of medical specialties, with the highest concentration focused on orthopedics (bone and cartilage repair), cardiology (myocardial infarction), neurology (spinal cord injury, stroke), and immunology (Graft-versus-Host Disease and autoimmune disorders). The vast majority of these investigations are currently in Phase I or II, evaluating safety and preliminary efficacy.

Despite the high volume of ongoing studies, only a small number of MSC-based therapies have achieved commercial regulatory approval, underscoring the challenges of achieving consistent efficacy in large-scale Phase III trials. Asia, particularly South Korea and Japan, leads the world in the number of approved cell therapy products, which contrasts sharply with the relatively few approvals granted by agencies like the US FDA and the European Medicines Agency (EMA). This global disparity highlights the region-specific maturity of the regenerative medicine space.

Related Reports