Key findings
- The FDA has cleared an Expanded Access program for StemCyte’s RegeneCyte, a cord blood-derived hematopoietic progenitor cell (HPC) therapy, for Long COVID.
- StemCyte points to Phase IIa results where 85% of treated patients had resolution of chronic fatigue vs 20% on placebo.
- The Expanded Access pathway is intended for patients with serious or life-threatening Long COVID symptoms who cannot enroll in ongoing Phase III trials.
StemCyte says the FDA has cleared an Expanded Access (EA) program for RegeneCyte, the company’s FDA-licensed hematopoietic progenitor cell (HPC) therapy derived from cord blood. The program is intended to provide access for eligible patients with Post-Acute Sequelae of SARS-CoV-2 (PASC, often called Long COVID) while the company continues its pivotal clinical research.
What the FDA action means
Expanded Access (sometimes called “compassionate use”) is a regulatory pathway that allows patients with serious or life-threatening conditions to receive an investigational therapy outside a clinical trial when certain criteria are met. StemCyte says this EA program is intended for Long COVID patients who are severely affected and may not meet enrollment criteria for the company’s ongoing Phase III multicenter trials.
Phase IIa data
StemCyte says the EA decision follows data from its Phase IIa trials in Long COVID. According to the company, 85% of Long COVID patients treated with RegeneCyte experienced a statistically significant resolution of chronic fatigue, compared to 20% in the placebo group.
“The FDA’s clearance of this program is a significant validation of the safety and therapeutic potential of RegeneCyte®, our HPC-cord blood product,” said Dr. Tong-Young Lee, CEO of StemCyte. “With our RMAT (Regenerative Medicine Advanced Therapy) designation already in place, this program allows us to bridge the gap for patients in need as we continue advancing RegeneCyte® through the clinical development and regulatory pathway.”
Company snapshot
StemCyte describes itself as a regenerative medicine company developing cell therapies, with a foundation in FDA-licensed cord blood products and a pipeline targeting Long COVID, stroke, and spinal cord injury.
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