Expanded Access Use of Human Umbilical Cord Blood (REGENECYTE) Infusion in Patients With Chronic Fatigue of Post-COVID Condition

StemCyte

Status

Conditions: Chronic Fatigue; Post-COVID Syndrome; Fatigue Post Viral; Long COVID; Post-COVID Condition; Chronic Fatigue Symptoms; Post-COVID-19 Condition

Treatments: Biological: REGENECYTE®

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT07332338

SCUS001-EA1

Details and patient eligibility

About

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

Full description

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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