Drugs / REGENECYTE
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT05682560 | May 2023 → Jul 2024 | long COVID-19 | StemCyte, Inc. | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT07184385 | Mar 2026 → Jun 2027 expected | long COVID-19, post-infectious syndrome | StemCyte, Inc. | Not yet recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT07332338 | — | long COVID-19, myalgic encephalomeyelitis/chronic fatigue syndrome | StemCyte, Inc. | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2026-01-26 | StemCyte, Inc. | Regulatory StemCyte Announces FDA Clearance of Expanded Access Program for REGENECYTE® to Address Unmet Need in Long COVID stemcyte.com ↗
StemCyte, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared an Expanded Access (EA) program for REGENECYTE® , the company’s FDA-licensed hematopoietic progenitor cell (HPC) therapy. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2026-01-26 | StemCyte, Inc. | StemCyte Announces FDA Clearance of Expanded Access Program for REGENECYTE® to Address Unmet Need in Long COVID stemcyte.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | REGENECYTE | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07184385 ↗ |
| Modality | Cell therapy | “REGENECYTE cord blood cell therapy in post-COVID syndrome: a phase IIa randomized, placebo-controlled trial.” PMID 41625963 ↗ Jan 2026 |
| Route | Intravenous | “we evaluated repeated intravenous infusions of REGENECYTE from different donors” PMID 41625963 ↗ Jan 2026 |