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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Shanghai Changhai Hospital
RECRUITING
Shanghai
Contact Information
Primary
Yuchao Dong, Doctor
dongyc1020@aliyun.com
+86 021-31161314
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 76
Treatments
Experimental: Treatment group
Participants will receive intravenous infusion of MSCs once or an additional infusion on days 35-42.~Dosage: 1×10\^6 cells per kilogram of body weight Specification: 1×10\^7 cells/100ml
Placebo_comparator: Placebo group
Participants will receive intravenous infusion of placebo Dosage: 10ml per kilogram of body weight
Related Therapeutic Areas
Sponsors
Leads: Changhai Hospital

This content was sourced from clinicaltrials.gov

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