Human Umbilical Cord Blood (RegeneCyte) Infusion in Patients With Post-COVID Syndrome
Purpose
RegeneCyte (HPC, Cord Blood, hUCB) for treatment in patients with post-COVID.
Conditions
- Long COVID
- Post-COVID Syndrome
- Post COVID-19 Condition
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental RegeneCyte |
HPC, Cord Blood |
|
|
Placebo Comparator Placebo |
Normal Saline |
|
Recruiting Locations
More Details
- NCT ID
- NCT05682560
- Status
- Active, not recruiting
- Sponsor
- StemCyte, Inc.
Detailed Description
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.