Official Title
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
Brief Summary

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

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.

Active, not recruiting
Long Covid
Post-Covid Syndrome
Post COVID-19 Condition

Biological: RegeneCyte

HPC, Cord Blood

Biological: Placebo

Normal Saline

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 65 Years
Countries
United States
Locations

Myrak Research Center
Miami Lakes, Florida, United States

Not Provided

StemCyte, Inc.
NCT Number
Keywords
long COVID
post-COVID syndrome
Post-COVID condition
Umbilical cord blood
RegeneCyte
MeSH Terms
Post-Acute COVID-19 Syndrome
Syndrome