Official Title
Expanded Access Use of Human Umbilical Cord Blood (REGENECYTE) Infusion for Patients With Post-COVID Condition
Brief Summary

REGENECYTE® (HPC, Cord Blood (Hematopoietic Progenitor Cell, Cord Blood)) for treatmentin patients with post-COVID.

Detailed Description

A total of 30 subjects with post-COVID will be enrolled.

Available
Intermediate-size Population
Post-COVID-19 Condition
Post-COVID Condition
Post-Covid Syndrome
Long Covid
Chronic Fatigue
Chronic Fatigue Symptoms
Fatigue Post Viral

Biological: REGENECYTE®

HPC, Cord Blood (Hematopoietic Progenitor Cell, Cord Blood)

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
(polyermerase chain reaction) or antigen test)

- Not eligible for participation in any ongoing clinical trials of post-COVID
condition with REGENECYTE

- 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 (IP) 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: N/A
Countries
United States
Locations

D&H National Research Center #1
Miami, Florida, United States

Myrak Research Center Inc.
Miami Lakes, Florida, United States

Contacts

Clinical Research Department
886-2-26013013 - 813
expandedaccess@stemcyte.com

StemCyte, Inc.
866-389-4659
expandedaccess@stemcyte.com

Not Provided

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