Actively Recruiting
Effectiveness and Safety of Mesenchymal Stem Cell Therapy in Long COVID Patients
Led by Changhai Hospital · Updated on 2024-07-09
76
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effectiveness and Safety of Mesenchymal Stem Cell Therapy in Long COVID Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meeting the diagnostic criteria for Long COVID according to WHO
- Main symptoms assessed based on CTCAE 5.0
- Symptoms evaluated to exclude other diseases by relevant specialists
- No recent plans for pregnancy and negative pregnancy test within 72 hours before starting the trial for women of childbearing age
- Willing to use effective non-pharmaceutical contraception during the study
- Signed informed consent and agreed to participate in the clinical trial
You will not qualify if you...
- Active malignant tumors
- Active infections
- Abnormal liver or kidney function (ALT or AST more than twice the upper limit; Creatinine more than twice the upper limit)
- Women who are pregnant, breastfeeding, or planning pregnancy during the trial
- Participation in other clinical trials within 3 months before screening
- Other reasons judged by the investigator to make participation inappropriate
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Changhai Hospital
Shanghai, China, 200433
Actively Recruiting
Research Team
Y
Yuchao Dong, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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