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

NCT05719012 | Withdrawn Phase 2

• 1 other identifier: DFSC-2023(CR)-02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Long COVID-19

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Changes of 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

  Changes from the baseline scores at Day 30, Day 60, Day 90 and Day 180

Study Arms (2)

UC-MSCs

EXPERIMENTAL

UC-MSCs

Biological: UC-MSCs

Placebo

PLACEBO COMPARATOR

0.9% Normal Saline

Biological: UC-MSCs

Interventions

UC-MSCs BIOLOGICAL

Intravenous injection three times with one-month interval

Placebo; UC-MSCs

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai East Hospital: lead

Study Sites (1)

Shanghai East Hosptial

Shanghai, 200000, China

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2023
• First Posted: February 8, 2023
• Study Start: April 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: March 30, 2024
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)