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

Study Overview
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Brief Summary
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RegeneCyte (HPC, Cord Blood, hUCB) for treatment in patients with post-COVID.

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

Official Title
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A Randomized Controlled Phase IIa, Two-arm Study to Assess the Safety and Efficacy of Human Umbilical Cord Blood (RegeneCyte) Infusion in Patients With Post-COVID Syndrome

Conditions
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Long COVID, Post-COVID Syndrome, Post COVID-19 Condition

Intervention / Treatment
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* Biological: RegeneCyte
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RegeneCyte<br>HPC, Cord Blood | Biological: RegeneCyte<br>* HPC, Cord Blood<br>|
| Placebo Comparator: Placebo<br>Normal Saline | Other: Placebo<br>* Normal Saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-emergent adverse events (TEAEs) | Incidence of treatment-emergent adverse events (TEAEs) | Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of efficacy | Change of efficacy evaluation | Week 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Long COVID, Post-COVID Syndrome, Post-COVID condition, Umbilical cord blood, RegeneCyte