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

• Sponsor: Shanghai East Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05719012
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 5.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Long COVID-19	Biological: UC-MSCs	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Mar 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

Secondary Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai East Hosptial	Shanghai		China	200000

Sponsors and Collaborators

• Shanghai East Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai East Hospital
• ClinicalTrials.gov Identifier: NCT05719012
• Other Study ID Numbers: DFSC-2023(CR)-02
• First Posted: Feb 8, 2023
• Last Update Posted: Feb 13, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Feb 13, 2023