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

NCT05682560 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: SCUS001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Long COVID; Post-COVID Syndrome; Post-COVID condition; Umbilical cord blood; RegeneCyte

Outcome Measures

Primary Outcomes (1)

• Treatment-emergent adverse events (TEAEs)

  Incidence of treatment-emergent adverse events (TEAEs)

  Baseline to Week 26

Secondary Outcomes (1)

• Change of fatigue score as measured by CFQ-11

  Baseline, Week 6, 12, 18 and 26

Study Arms (2)

REGENECYTE

EXPERIMENTAL

HPC, Cord Blood

Biological: REGENECYTE

Placebo

PLACEBO COMPARATOR

Normal Saline

Biological: Placebo

Interventions

REGENECYTE BIOLOGICAL

HPC, Cord Blood

REGENECYTE

Placebo BIOLOGICAL

Normal Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Male or female aged ≥ 18
• \. With post-COVID syndrome
• \. 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

You may not qualify if:

• \. 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
• \. Judged by the investigator to be not suitable for study participation
• \. Under the conditions that may increase risk of complications based on the medical judgment of the investigator and the parameters

Sponsors & Collaborators

• StemCyte, Inc.: lead
• StemCyte Taiwan Co., Ltd.: collaborator

Study Sites (1)

Myrak Research Center

Miami Lakes, Florida, 33016, United States

Location

Related Publications (1)

• Huang YW, Chen YC, Lun Lau EY, Su YC, Tai LK, Rosenthal J, Wang J, Lee TY. REGENECYTE cord blood cell therapy in post-COVID syndrome: a phase IIa randomized, placebo-controlled trial. EClinicalMedicine. 2026 Jan 9;91:103737. doi: 10.1016/j.eclinm.2025.103737. eCollection 2026 Jan.

  PMID: 41625963 DERIVED

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 12, 2023
• Study Start: May 4, 2023
• Primary Completion: July 26, 2024
• Study Completion: February 27, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

US (1)