A Study of Human Umbilical Cord Blood (REGENECYTE) Infusion in Patients With Post-COVID Condition

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07184385
• Lead Sponsor: StemCyte, Inc.

Brief Summary

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

Detailed Description

This is a two-arm, multi-center, double-blind, randomized, placebo-controlled phase III study. A total of 60 subjects with post-COVID will be enrolled.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-17
• Study First Submitted QC: 2025-09-17
• Last Update Submitted: 2025-09-18
• Study First Posted: 2025-09-19
• Last Update Posted: 2025-09-23
• Study Start: 2026-03-31
• Primary Completion: 2027-06-30
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Male or female aged ≥ 18
• With post-COVID condition
• Has had a recent (within 7 days) negative SARS-CoV-2 test (an approved PCR or antigen test)
• Able to provide signed informed consent (by the subject or his/her legally authorized representative)
• 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

• Neurological disorders prior to COVID-19 diagnosis
• With pre-existing terminal illness
• With known immune disease
• Is pregnant or breastfeeding
• Is currently participating in another investigational study or has been taking any other investigational product within the last 4 weeks before screening
• Has received any vaccination within 3 weeks prior to the first IP infusion or planning to receive vaccination during the treatment period
• Judged by the investigator to be not suitable for study participation, including but not limited to pre-existing chronic diseases
• 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
The change of efficacy	Week	Change of efficacy evaluation

Secondary Outcome Measures

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