Human Umbilical Cord Blood (RegeneCyte) Infusion in Patients with Post-COVID Syndrome

NCT ID: NCT05682560

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-04
• Study Completion Date: 2025-02-27

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.

Conditions

Long COVID; Post-COVID Syndrome; Post COVID-19 Condition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

REGENECYTE

HPC, Cord Blood

Group Type: EXPERIMENTAL

REGENECYTE

Intervention Type: BIOLOGICAL

HPC, Cord Blood

Placebo

Normal Saline

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Normal Saline

Interventions

REGENECYTE

HPC, Cord Blood

Intervention Type: BIOLOGICAL

Placebo

Normal Saline

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

StemCyte Taiwan Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

StemCyte, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Myrak Research Center

Miami Lakes, Florida, United States

Countries

United States

Other Identifiers

SCUS001

Identifier Type: -

Identifier Source: org_study_id