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

March 19, 2025 updated by: StemCyte, Inc.

A Randomized Controlled Phase IIa, Two-arm Study to Assess the Safety and Efficacy of Human Umbilical Cord Blood (RegeneCyte) Infusion in Patients with Post-COVID Syndrome

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami Lakes, Florida, United States, 33016
        • Myrak Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Normal Saline
Biological: Placebo
Normal Saline
Experimental: REGENECYTE
HPC, Cord Blood
Biological: REGENECYTE
HPC, Cord Blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-emergent adverse events (TEAEs)
Time Frame: Baseline to Week 26
Incidence of treatment-emergent adverse events (TEAEs)
Baseline to Week 26

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of fatigue score as measured by CFQ-11
Time Frame: Baseline, Week 6, 12, 18 and 26
Baseline, Week 6, 12, 18 and 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

StemCyte, Inc.

Collaborators

StemCyte Taiwan Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2023

Primary Completion (Actual)

July 26, 2024

Study Completion (Actual)

February 27, 2025

Study Registration Dates

First Submitted

January 11, 2023

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 19, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCUS001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

All information supplied by StemCyte, Inc in connection with this study and not previously published, is considered confidential information. This information includes, but is not limited to, the Investigator's Brochure, clinical protocol, case report forms and other scientific data. All data collected during the study are confidential. This confidential information shall remain the sole property of StemCyte, Inc, shall not be disclosed to others without the written consent of StemCyte, Inc, and shall not be used except in the performance of this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Long COVID

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe