Comment from Gillian McCrea
AnonymousSupportBusiness
Summary: StemCyte is advocating for the accelerated approval and repurposing of its cord blood cell therapy, REGENECYTE, for the treatment of Long COVID fatigue. They highlight positive Phase IIa trial data and request that the FDA address cost and coverage barriers to ensure patient access.
REGENECYTE (StemCyte) for Long COVID
An FDA-licensed cord blood cell therapy with positive placebo-controlled fatigue data | For FDA repurposing / advisory review
The opportunity
A cord blood–derived cell therapy has already beaten placebo on Long COVID fatigue, carries FDA Regenerative Medicine Advanced Therapy designation, and has an FDA-cleared access pathway — held back mainly by cost.
The evidence is already here
In a randomized, placebo-controlled Phase IIa trial published in The Lancet’s eClinicalMedicine, 85% of REGENECYTE-treated patients had statistically significant resolution of chronic fatigue versus 20% on placebo (p<0.01), with a favorable safety profile and only mild treatment-emergent events [1,2].
The therapy
REGENECYTE is an allogeneic cord blood–derived hematopoietic progenitor cell (HPC) therapy delivered by infusion; cord blood cells are immunomodulatory and regenerative, targeting the immune dysregulation and tissue injury that underlie Long COVID. It is the only FDA-licensed cord blood product in U.S. Long COVID trials [3].
The regulatory momentum is real
The FDA granted RMAT designation (October 2024), a positive End-of-Phase-2 meeting (March 2025) supported the pivotal design, a Phase III multicenter randomized trial is underway (NCT07184385), and the FDA cleared an Expanded Access program (January 2026) for severely affected patients who cannot enroll [3,4].
The barrier
Even with Expanded Access cleared, the therapy remains expensive and out of reach for most patients — access exists on paper but not in practice.
The ask
Accelerate the Phase III and the RMAT-based approval pathway, and address cost and coverage so the Expanded Access route is usable by the patients who need it. The efficacy signal and the regulatory groundwork are already in place.
Sources
1. StemCyte Phase IIa RCT of REGENECYTE (HPC, Cord Blood) in post-COVID syndrome: 85% fatigue resolution vs 20% placebo (p<0.01). eClinicalMedicine (Lancet); original trial NCT05682560.
2. StemCyte Phase IIa results announcement, December 2024 (favorable safety, mild TEAEs).
3. StemCyte REGENECYTE Long COVID program: FDA RMAT designation (Oct 2024); Phase III RCT NCT07184385.
4. FDA-cleared Expanded Access program for REGENECYTE in Long COVID, January 2026 (NCT07332338).