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Purpose

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

Conditions

Eligibility

Eligible Ages
Between 18 Years and 65 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

ArmDescriptionAssigned Intervention
Experimental
RegeneCyte 		HPC, Cord Blood
  • Biological: RegeneCyte
    HPC, Cord Blood
Placebo Comparator
Placebo 		Normal Saline
  • Biological: Placebo
    Normal Saline

Recruiting Locations

More Details

NCT ID
NCT05682560
Status
Active, not recruiting
Sponsor
StemCyte International, Ltd.

Detailed Description

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.