Novo Clinic conducts regenerative medicine research aimed at generating clinically rigorous data to support United States Food and Drug Administration regulatory evaluation and approval pathways. These investigations are structured to meet established scientific ethical and methodological standards applicable to advanced biologic clinical research.
In collaboration with Riordan Technologies and The Stem Cell Institute, Novo Clinic has conducted Institutional Review Board approved clinical studies evaluating the safety feasibility and biological activity of umbilical cord derived mesenchymal stem cell interventions for degenerative disc disease and related spinal disorders. Study protocols were developed in accordance with internationally accepted principles of human subject research and prospective clinical investigation.
All regenerative medicine studies were completed within the regulatory jurisdiction of the Cayman Islands. Novo Clinic functioned as the first overseas clinical research center to participate in this class of stem cell investigations intended to inform United States Food and Drug Administration review. The generation of clinically relevant data in this setting demonstrates the feasibility of conducting FDA aligned biologic research outside the continental United States while maintaining regulatory integrity.
Cellular products utilized in these investigations were manufactured processed and released in compliance with current Good Manufacturing Practice and current Good Tissue Practice requirements. Manufacturing and tissue processing were performed at ISO certified and AATB accredited facilities ensuring standardized quality control donor eligibility verification and full material traceability.
Novo Clinic was granted the CTL 009 license authorizing the conduct and completion of these studies within the Cayman Islands regulatory framework. The successful execution of this research program underscores the clinic’s capacity to serve as an international clinical research site capable of producing regulator ready biologic data consistent with United States Food and Drug Administration expectations and global standards of clinical research practice.