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

Phase 2

Withdrawn

• Conditions: Long COVID-19
• Interventions: Biological: UC-MSCs

• Registration Number: NCT05719012
• Lead Sponsor: Shanghai East Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-29
• Study First Submitted QC: 2023-02-07
• Study First Posted: 2023-02-08
• Study Start: 2023-04-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-17
• Last Update Posted: 2023-11-21
• Primary Completion: 2023-12-01
• Study Completion: 2024-03-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UC-MSCs	UC-MSCs	UC-MSCs
Placebo	UC-MSCs	0.9% Normal Saline

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai East Hosptial; 🇨🇳 Shanghai, China