Effectiveness and Safety of Mesenchymal Stem Cell Therapy in Long COVID Patients

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Long COVID, Post-Acute COVID-19 Syndrome

In brief

The goal of this clinical trial is to evaluate the effectiveness and safety of mesenchymal stem cell therapy in long-COVID patients. The main questions it aims to answer include: * whether umbilical cord mesenchymal stem cell therapy does benefit long-COVID patients * whether umbilical cord mesenchymal stem cell therapy is safe for long-COVID patients. Participants' demographics, chief complaints, and vital signs will be collected and recorded. Basic physical examinations, bloodwork routine, biochemical indexes, oxygen saturation (SpO2) levels, 6-minute walk tests, high-resolution computed tomography (HRCT) scan (if necessary) results will be conducted. Participants will receive either an intravenous infusion of mesenchymal stem cells, or a placebo for one time. Participants' symptoms will be assessed on Day 28 of the trial. If there is no significant effect, an additional infusion will be given on Days 35-42, and the symptoms will be reassessed 28 days after that. Continuous nebulized inhalation of UCMSC-derived exosomes will be administered for 5 days twice daily to treatment group, with no treatment given to the control group. Researchers will compare data and information collected from the treatment and control groups to evaluate the safety and efficacy of UCMSC-derived exosomes for the treatment of chronic cough after COVID-19 infection.

Key facts

Study ID

NCT06492798

Run by

Changhai Hospital

People needed

76

Starts

2023-09-01

Expected to finish

2026-08-31

Last updated by the study team

2024-07-09

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meeting the diagnostic criteria for Long COVID according to WHO.
• Main symptoms assessed based on CTCAE 5.0.
• Symptoms evaluated for exclusion reasons of other diseases by relevant specialists.
• No recent plans for pregnancy (negative pregnancy test within 72 hours for women of childbearing age prior to the start of the trial), and willing to use effective non-pharmaceutical contraceptive measures during the study.
• Signed informed consent forms and agreements to participate in this clinical trial.

You may not qualify if…

• Active malignant tumors.
• Active infections.
• Abnormal liver or kidney function (ALT, AST > 2 times the upper limit of normal; Cr > 2 times the upper limit of normal).
• Women who are pregnant, lactating, or planning to become pregnant during the trial.
• Participated in other clinical trials within the last 3 months prior to screening.
• Other reasons deemed inappropriate for participation by the investigator.

Where it is running

• Shanghai Changhai Hospital — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

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