Official Title
A Multicenter, Double-blind, Randomized, Placebo-controlled, Two-arm Phase III Study to Assess the Efficacy of Human Umbilical Cord Blood (REGENECYTE) Infusion in Reducing Fatigue in Post-COVID Condition
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.

Not yet recruiting
Long Covid
Post-COVID-19 Condition
Post-Covid Syndrome
Post-COVID Condition

Biological: REGENECYTE

HPC, Cord Blood

Biological: Placebo

Normal Saline

Eligibility Criteria

Inclusion Criteria:

- 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 Criteria:

- 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

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

Not Provided

Contacts

Ernest Lau, MS
886-2-26013013 - 813
Sct_pCOV02@stemcyte.com.tw

Not Provided

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