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

Back to results

Primary Purpose

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

RegeneCyte

Placebo

About this trial

This is an interventional treatment trial for Long COVID focused on measuring Long COVID, Post-COVID Syndrome, Post-COVID condition, Umbilical cord blood, RegeneCyte

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Myrak Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RegeneCyte

Placebo

Arm Description

HPC, Cord Blood

Normal Saline

Outcomes

Primary Outcome Measures

Treatment-emergent adverse events (TEAEs)

Incidence of treatment-emergent adverse events (TEAEs)

Secondary Outcome Measures

The change of efficacy

Change of efficacy evaluation

Full Information

NCT ID

NCT05682560

First Posted

January 11, 2023

Last Updated

May 10, 2023

Sponsor

StemCyte, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05682560

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 4, 2023 (Actual)

Primary Completion Date

October 2024 (Anticipated)

Study Completion Date

October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

StemCyte, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

This is a two-arm, multi-national, multi-center, single-blind, randomized, placebo-controlled phase IIa study. A total of 30 subjects with post-COVID will be enrolled.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Long COVID, Post-COVID Syndrome, Post COVID-19 Condition

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

RegeneCyte

Arm Type

Experimental

Arm Description

HPC, Cord Blood

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Normal Saline

Intervention Type

Biological

Intervention Name(s)

RegeneCyte

Intervention Description

HPC, Cord Blood

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Normal Saline

Primary Outcome Measure Information:

Title

Treatment-emergent adverse events (TEAEs)

Description

Incidence of treatment-emergent adverse events (TEAEs)

Time Frame

Week 48

Secondary Outcome Measure Information:

Title

The change of efficacy

Description

Change of efficacy evaluation

Time Frame

Week 48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

No

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bobo Chen, PhD

Phone

02-26558558

Ext

300

Email

Sct_pCOV01@stemcyte.com.tw

Facility Information:

Facility Name

Myrak Research Center

City

Miami Lakes

State/Province

Florida

ZIP/Postal Code

33014

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kelly O Reilly

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing 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.

Long COVID, Post-COVID Syndrome, Post COVID-19 Condition

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial