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

Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Long COVID-19: a Randomized, Double-blind, Parallel-controlled Study

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

Study Overview

• Status: Withdrawn
• Conditions: Long COVID-19
• Intervention / Treatment: Biological: UC-MSCs

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200000
    • Shanghai East Hosptial
    • Contact: Zhongming Liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The age ranges from 18 to 85 (inclusive), regardless of gender.
2. Patients with Confirmed SARS-CoV-2 infection, according to the consensus of the Chinese diagnostic criteria for COVID-19 (Tentative tenth Edition).
3. 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.
4. Be expected to live longer than 1 year.
5. Volunteer to participate in this clinical study and sign the written informed consent.

Exclusion Criteria:

1. Those who are using immunosuppressive drugs or long-term immunosuppressive drugs after organ transplantation.
2. T lymphocyte abnormality, HIV positive.
3. Highly allergic or have a history of severe allergy.
4. Pregnant and lactating women.
5. Patients with severe autoimmune disease history;
6. Patients with uncontrolled chronic diseases or serious complications;
7. Patients with malignant tumors;
8. Patients with pulmonary embolism, acute coronary syndrome, cerebral embolism or at high risk of thromboembolism;
9. Patients with severe organ dysfunction
10. Other situations that the researchers think are not suitable for participating in this study

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 0.9% Normal Saline	Biological: UC-MSCs; Intravenous injection three times with one-month interval
Experimental: UC-MSCs	Biological: UC-MSCs; Intravenous injection three times with one-month interval

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six min walking distances	The maximum distance a person can walk in 6 min and acts as an endurance walking measure.	Changes from baseline index at Day 30, Day 60, Day 90 and Day 180
Lung function	The lung function assessed using FEV1, FEV1/FVC and DLco	Changes from the baseline index at Day 30, Day 60, Day 90 and Day 180

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of the levels of Inflammatory cytokines	The levels of Inflammatory cytokines	Changes from the baseline levels at Day 30, Day 60, Day 90 and Day 180
Changes of the scores of Multidimensional Fatigue Inventory	The degree of fatigue	Changes from the baseline scores at Day 30, Day 60, Day 90 and Day 180

Collaborators and Investigators

• Sponsor: Shanghai East Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): March 30, 2024

Study Registration Dates

• First Submitted: January 29, 2023
• First Submitted That Met QC Criteria: February 7, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Chronic Disease; Post-Infectious Disorders; COVID-19; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: DFSC-2023(CR)-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No