COMPANY

StemCyte

HQ: Baldwin Park, CA source · stemcyte.com ↗

FDA-approved therapeutic company FDA-cleared device company Clinical Phase 3

Keywords: long COVID acute ischemic stroke cerebral palsy cell therapy Post-COVID-19 Condition Post-COVID Syndrome Post-COVID Condition Chronic Fatigue Chronic Fatigue Symptoms Fatigue Post Viral Spinal Cord Injuries REGENECYTE REGENECYTE® hUCB

Location: Baldwin Park, CA · source · Oct 13, 2026

Profile checked Oct 10, 2026

5Trials (company is sponsor)1FDA records (2 yrs)

Timeline

Mar 31, 2026 Trial start Phase 3: A Study of Human Umbilical Cord Blood (REGENECYTE) Infusion in Patients With Post-COVID Condition source ↗
2025-09 Trial start Phase 2: Human Umbilical Cord Blood Infusion in Patients with Acute Ischemic Stroke (AIS) source ↗
Nov 21, 2024 FDA FDA Original approval: regenecyte (hpc, cord blood) — BLA125764, Nov 21, 2024. Applicant at approval: StemCyte, Inc. source ↗
May 4, 2023 Trial start Phase 2: Human Umbilical Cord Blood (RegeneCyte) Infusion in Patients with Post-COVID Syndrome source ↗
Feb 22, 2022 Trial start Phase 2: Umbilical Cord Blood Cell (MC001) Transplant Into Injured Spinal Cord Followed by the Locomotor Training source ↗

Upcoming milestones

Jun 30, 2027 (ESTIMATED) · Phase 3 · A Study of Human Umbilical Cord Blood (REGENECYTE) Infusion in Patients With Post-COVID Condition · NCT07184385
2027-12 (ESTIMATED) · Phase 2 · Human Umbilical Cord Blood Infusion in Patients with Acute Ischemic Stroke (AIS) · NCT06040476

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 5

Record	Title	Phase	Status	Start	Primary completion
NCT07332338	Expanded Access Use of Human Umbilical Cord Blood (REGENECYTE) Infusion in Patients With Chronic Fatigue of Post-COVID Condition	Not listed	Available	Not listed	Not listed
NCT07184385	A Study of Human Umbilical Cord Blood (REGENECYTE) Infusion in Patients With Post-COVID Condition	Phase 3	Not yet recruiting	Mar 31, 2026	Jun 30, 2027 (estimated)
NCT05682560	Human Umbilical Cord Blood (RegeneCyte) Infusion in Patients with Post-COVID Syndrome	Phase 2	Completed	May 4, 2023	Jul 26, 2024 (actual)
NCT03979742	Umbilical Cord Blood Cell (MC001) Transplant Into Injured Spinal Cord Followed by the Locomotor Training	Phase 2	Terminated	Feb 22, 2022	Dec 30, 2024 (actual)
NCT06040476	Human Umbilical Cord Blood Infusion in Patients with Acute Ischemic Stroke (AIS)	Phase 2	Not yet recruiting	2025-09	2027-12 (estimated)

FDA records (last 2 years)

Nov 21, 2024 FDA Original approval: regenecyte (hpc, cord blood) — BLA125764, Nov 21, 2024. Applicant at approval: StemCyte, Inc. source ↗