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

Phase 2

Active, not recruiting

• Conditions: Long COVID; Post-COVID Syndrome; Post COVID-19 Condition

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-1-11
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - <br><br> 1. Male or female aged = 18<br><br> - <br><br> 2. With post-COVID syndrome<br><br> - <br><br> 3. Has had a recent (within 7 days) negative SARS-CoV-2 test (an approved PCR or<br> antigen test)<br><br> - <br><br> 4. Able to provide signed informed consent (by the subject or his/her legally<br> authorized representative)<br><br> - <br><br> 5. Is willing and able to participate in all aspects of the study, including<br> completion of subjective evaluations, attendance at scheduled clinic visits,<br> and compliance with all protocol requirements as evidenced by providing a<br> written informed consent<br><br>Exclusion Criteria:<br><br> - <br><br> 1. Neurological disorders prior to COVID-19 diagnosis<br><br> - <br><br> 2. With pre-existing terminal illness<br><br> - <br><br> 3. With known immune disease<br><br> - <br><br> 4. Is pregnant or breastfeeding<br><br> - <br><br> 5. Is currently participating in another investigational study or has been taking<br> any other investigational product within the last 4 weeks before screening<br><br> - <br><br> 6. Has received any vaccination within 3 weeks prior to the first IP infusion<br><br> - <br><br> 7. Judged by the investigator to be not suitable for study participation<br><br> - <br><br> 8. Under the conditions that may increase risk of complications based on the<br> medical judgment of the investigator and the parameters

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment-emergent adverse events (TEAEs)

Secondary Outcome Measures

Name	Time	Method
The change of efficacy