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Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Long COVID-19

Primary Purpose

Long COVID-19

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
UC-MSCs
Sponsored by
Shanghai East Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Long COVID-19

Eligibility Criteria

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

Inclusion Criteria: The age ranges from 18 to 85 (inclusive), regardless of gender. Patients with Confirmed SARS-CoV-2 infection, according to the consensus of the Chinese diagnostic criteria for COVID-19 (Tentative tenth Edition). Patients with symptoms of long COVID-19 3 months from the onset of COVID-19, lasting for at least 2 months, and the symptoms cannot be explained by other diseases. Be expected to live longer than 1 year. Volunteer to participate in this clinical study and sign the written informed consent. Exclusion Criteria: Those who are using immunosuppressive drugs or long-term immunosuppressive drugs after organ transplantation. T lymphocyte abnormality, HIV positive. Highly allergic or have a history of severe allergy. Pregnant and lactating women. Patients with severe autoimmune disease history; Patients with uncontrolled chronic diseases or serious complications; Patients with malignant tumors; Patients with pulmonary embolism, acute coronary syndrome, cerebral embolism or at high risk of thromboembolism; Patients with severe organ dysfunction Other situations that the researchers think are not suitable for participating in this study

Sites / Locations

  • Shanghai East Hosptial

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

UC-MSCs

Placebo

Arm Description

UC-MSCs

0.9% Normal Saline

Outcomes

Primary Outcome Measures

Six min walking distances
The maximum distance a person can walk in 6 min and acts as an endurance walking measure.
Lung function
The lung function assessed using FEV1, FEV1/FVC and DLco

Secondary Outcome Measures

Changes of the levels of Inflammatory cytokines
The levels of Inflammatory cytokines
Changes of the scores of Multidimensional Fatigue Inventory
The degree of fatigue

Full Information

First Posted
January 29, 2023
Last Updated
February 9, 2023
Sponsor
Shanghai East Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05719012
Brief Title
Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Long COVID-19
Official Title
Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Long COVID-19: a Randomized, Double-blind, Parallel-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai East Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To explore the efficacy and safety of Umbilical cord mesenchymal stem cells in the treatment of long COVID-19

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UC-MSCs
Arm Type
Experimental
Arm Description
UC-MSCs
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0.9% Normal Saline
Intervention Type
Biological
Intervention Name(s)
UC-MSCs
Intervention Description
Intravenous injection three times with one-month interval
Primary Outcome Measure Information:
Title
Six min walking distances
Description
The maximum distance a person can walk in 6 min and acts as an endurance walking measure.
Time Frame
Changes from baseline index at Day 30, Day 60, Day 90 and Day 180
Title
Lung function
Description
The lung function assessed using FEV1, FEV1/FVC and DLco
Time Frame
Changes from the baseline index at Day 30, Day 60, Day 90 and Day 180
Secondary Outcome Measure Information:
Title
Changes of the levels of Inflammatory cytokines
Description
The levels of Inflammatory cytokines
Time Frame
Changes from the baseline levels at Day 30, Day 60, Day 90 and Day 180
Title
Changes of the scores of Multidimensional Fatigue Inventory
Description
The degree of fatigue
Time Frame
Changes from the baseline scores at Day 30, Day 60, Day 90 and Day 180

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: The age ranges from 18 to 85 (inclusive), regardless of gender. Patients with Confirmed SARS-CoV-2 infection, according to the consensus of the Chinese diagnostic criteria for COVID-19 (Tentative tenth Edition). Patients with symptoms of long COVID-19 3 months from the onset of COVID-19, lasting for at least 2 months, and the symptoms cannot be explained by other diseases. Be expected to live longer than 1 year. Volunteer to participate in this clinical study and sign the written informed consent. Exclusion Criteria: Those who are using immunosuppressive drugs or long-term immunosuppressive drugs after organ transplantation. T lymphocyte abnormality, HIV positive. Highly allergic or have a history of severe allergy. Pregnant and lactating women. Patients with severe autoimmune disease history; Patients with uncontrolled chronic diseases or serious complications; Patients with malignant tumors; Patients with pulmonary embolism, acute coronary syndrome, cerebral embolism or at high risk of thromboembolism; Patients with severe organ dysfunction Other situations that the researchers think are not suitable for participating in this study
Facility Information:
Facility Name
Shanghai East Hosptial
City
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongming Liu
First Name & Middle Initial & Last Name & Degree
Hua Jiang

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Long COVID-19

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