FDA Clears Expanded Access Program for HPC Therapy in Patients With Long COVID

The Food and Drug Administration recently cleared an expanded access program for StemCyte’s cord blood-derived hematopoietic progenitor cell (HPC) therapy (RegeneCyte) for patients with post-acute sequelae of SARS-CoV-2 infection (long COVID). The program allows eligible patients to access the therapy outside of clinical trials while the company continues its clinical research.

According to the company, the expanded access authorization is supported by data from phase 2 study, in which 85% of treated patients experienced a statistically significant resolution of chronic fatigue, compared with 20% in the placebo group. 

The therapy previously received Regenerative Medicine Advanced Therapy (RMAT) Designation