Effectiveness and Safety of Mesenchymal Stem Cell Therapy in Long COVID Patients
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorChanghai Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
umbilical cord mesenchymal stem cell
Drugintravenous infusion of umbilical cord mesenchymal stem cell
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: Treatment groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Common Terminology Criteria for Adverse Events (CTCAE5.0)
CTCAE is a descriptive terminology which can be used for Adverse Event (AE) reporting. An Adverse Event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Higher grades mean worse outcome.
Time frame
28th daySecondary outcomes
1
Common Terminology Criteria for Adverse Events (CTCAE5.0)
CTCAE is a descriptive terminology which can be used for Adverse Event (AE) reporting. An Adverse Event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Higher grades mean worse outcome.
Time frame
12th week, 24th weekOther outcomes
1
C reactive protein(CRP)
For paticipants with high C reactive protein level at enrollment, C reactive protein will be tested. Level of CRP change and time for its relief will be recorded.
Time frame
28th day, 12th week, 24th week2
Dosage of corticosteroids
For paticipants using corticosteroids to treat long COVID, total dosage and course of corticosteroids will be recorded.
Time frame
28th day, 12th week, 24th week3
SpO2
For paticipants with pulmonary fibrosis, SpO2 will be tested and evaluated.
Time frame
28th day, 12th week, 24th week4
6-minute walk test
For paticipants with pulmonary fibrosis, 6-minute walk testwill be tested and evaluated.
Time frame
28th day, 12th week, 24th weekSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov