Human Umbilical Cord Blood (RegeneCyte) Infusion in Patients with Post-COVID Syndrome

Phase 2

Completed

• Conditions: Post-COVID Syndrome; Post COVID-19 Condition; Long COVID
• Interventions: Biological: REGENECYTE; Biological: Placebo

• Registration Number: NCT05682560
• Lead Sponsor: StemCyte, Inc.

Brief Summary

REGENECYTE (HPC, Cord Blood, hUCB) for treatment in patients with post-COVID.

Detailed Description

This is a two-arm, single-center, single-blind, randomized, placebo-controlled phase IIa study. A total of 30 subjects with post-COVID will be enrolled.

Study Timeline

• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-12
• Study Start: 2023-05-04
• Primary Completion: 2024-07-26
• Study Completion: 2025-02-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 1. Male or female aged ≥ 18
• 2. With post-COVID syndrome
• 3. Has had a recent (within 7 days) negative SARS-CoV-2 test (an approved PCR or antigen test)
• 4. Able to provide signed informed consent (by the subject or his/her legally authorized representative)
• 5. Is willing and able to participate in all aspects of the study, including completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing a written informed consent

Exclusion Criteria

• 1. Neurological disorders prior to COVID-19 diagnosis
• 2. With pre-existing terminal illness
• 3. With known immune disease
• 4. Is pregnant or breastfeeding
• 5. Is currently participating in another investigational study or has been taking any other investigational product within the last 4 weeks before screening
• 6. Has received any vaccination within 3 weeks prior to the first IP infusion
• 7. Judged by the investigator to be not suitable for study participation
• 8. Under the conditions that may increase risk of complications based on the medical judgment of the investigator and the parameters

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REGENECYTE	REGENECYTE	HPC, Cord Blood
Placebo	Placebo	Normal Saline

Primary Outcome Measures

Name	Time	Method
Treatment-emergent adverse events (TEAEs)	Baseline to Week 26	Incidence of treatment-emergent adverse events (TEAEs)

Secondary Outcome Measures

Name	Time	Method
Change of fatigue score as measured by CFQ-11	Baseline, Week 6, 12, 18 and 26

Trial Locations

Locations (1)

Myrak Research Center; 🇺🇸 Miami Lakes, Florida, United States