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Clinical Trial NCT07184385 for Long COVID, Post-COVID-19 Condition, Post-COVID Syndrome, Post-COVID Condition is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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A Study of Human Umbilical Cord Blood (REGENECYTE) Infusion in Patients With Post-COVID Condition
Clinical Trial NCT07184385 is designed to study Treatment for Long COVID, Post-COVID-19 Condition, Post-COVID Syndrome, Post-COVID Condition. This Phase 3 interventional trial is not yet recruiting. Enrollment is planned to begin on 31 March 2026 until the trial accrues 60 participants. Led by StemCyte, Inc., this trial is expected to complete by 30 September 2027. The latest data from ClinicalTrials.gov was last updated on 23 September 2025.
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.
Official Title
A Multicenter, Double-blind, Randomized, Placebo-controlled, Two-arm Phase III Study to Assess the Efficacy of Human Umbilical Cord Blood (REGENECYTE) Infusion in Reducing Fatigue in Post-COVID Condition
Conditions
Long COVIDPOST-COVID-19 ConditionPost-covid SyndromePost-covid ConditionOther Study IDs
- SCUS002
NCT ID Number
Start Date (Actual)
2026-03-31
Last Update Posted
2025-09-23
Completion Date (Estimated)
2027-09-30
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
Phase 3
Status
Not yet recruiting
Keywords
Post-COVID condition
Post-COVID syndrome
Long COVID
REGENECYTE
Post-COVID fatigue
Umbilical cord blood
Post-COVID syndrome
Long COVID
REGENECYTE
Post-COVID fatigue
Umbilical cord blood
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalREGENECYTE HPC, Cord Blood | REGENECYTE HPC, Cord Blood |
Placebo ComparatorPlacebo Normal Saline | Placebo Normal Saline |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
The change of efficacy | Change of efficacy evaluation | Week |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Treatment-emergent adverse events (TEAEs) | Incidence of treatment-emergent adverse events (TEAEs) | Week |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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 Central Contact
Contact: Ernest Lau, MS, 886-2-26013013, [email protected]
No location data.