StemCyte has announced a significant advancement in its clinical program for REGENECYTE, an umbilical cord blood cell therapy under development for long COVID syndrome. Following a formal End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA), the company received written confirmation of positive regulatory feedback supporting the design of its upcoming Phase III pivotal trial.
The EOP2 meeting, held in March 2025, addressed key aspects of the clinical program, including trial design, clinical data, and manufacturing controls. According to the FDA’s meeting minutes, REGENECYTE’s Phase II data was well received, and the agency provided specific guidance for optimizing the Phase III trial. This included recommendations that may reduce the number of participants required and shorten the overall timeline.
Based on this input, StemCyte plans to launch its Phase III trial ahead of schedule. In parallel, REGENECYTE has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and has been approved for compassionate use, allowing paid access to treatment for long COVID in the U.S. while the therapy remains in development.
The long COVID population is projected to be large, with estimates suggesting that as many as 400 million individuals worldwide may be affected. StemCyte’s regulatory progress may position REGENECYTE as one of several emerging therapies addressing the clinical and public health challenges associated with long COVID.
