Status:
NOT_YET_RECRUITING
A Study of Human Umbilical Cord Blood (REGENECYTE) Infusion in Patients With Post-COVID Condition
Lead Sponsor:
StemCyte, Inc.
Conditions:
Long COVID
Post-COVID-19 Condition
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 31 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07184385
Start Date
March 31 2026
End Date
September 30 2027
Last Update
September 23 2025
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