UC-MSCs in the Treatment of Severe and Critical COVID-19 Patients With Refractory Hypoxia
NCT ID: NCT05689008
Last Updated: 2023-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
60 participants
INTERVENTIONAL
2023-01-10
2023-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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control
Participants will receive standard therapy, including oxygen therapy，glucocorticoid and other antiinflammatory drugs and supportive treatments according the ninth edition of Chinese guidelines for the treatment of COVID-19 infection.
No interventions assigned to this group
UC-MSCs treatment
Participants will receive two doses of UC-MSCs instillation at the first and fourth day after the assignment on the basis of standard treatment.
UC-MSCs treatment
Participants will receive two doses of UC-MSCs treatment, each dose will contain 1\*10\^6 cells/kg suspended in 100 ml albumin solution.
Interventions
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UC-MSCs treatment
Participants will receive two doses of UC-MSCs treatment, each dose will contain 1\*10\^6 cells/kg suspended in 100 ml albumin solution.
Eligibility Criteria
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Inclusion Criteria
* Patients who still have refractory hypoxia after sufficient standard treatment for severe and critical COVID-19 pneumonia following the suggestion of the Chinese diagnostic criteria for COVID-19 pneumonia in the Diagnosis and Treatment Plan for COVID-19 Pneumonia (Tentative tenth Edition).
* 20kg/m2≤body mass index(BMI)≤30 kg/m2.
* Volunteer to participate in this clinical study and sign the written informed consent
Exclusion Criteria
* T lymphocyte abnormality (allogeneic may be considered, depending on clinical opinion), HIV positive.
* Highly allergic or have a history of severe allergy, especially Interleukin-2 allergy.
* Pregnant and lactating women.
* Patients with severe autoimmune disease history; Allergies to all biological reagents in this treatment, such as Interleukin-2.
* Patients with serious complications, including chronic cardiac insufficiency (NYHA cardiac function grading assessment of cardiac function grade III - IV), chronic renal insufficiency (CKD stage 3 and above); Chronic liver insufficiency (Child-Pugh score\>7); Patients with malignant tumors.
* Patients with pulmonary embolism or acute coronary syndrome.
* Patients with severe organ dysfunction caused by other diseases.
* There are other situations that the researcher thinks are not suitable to participate in this clinical study
18 Years
85 Years
ALL
No
Sponsors
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Sir Run Run Shaw Hospital
OTHER
Shanghai East Hospital
OTHER
Responsible Party
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Principal Investigators
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Zhongmin Liu, Dr.
Role: STUDY_CHAIR
Shanghai East Hospital
Locations
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Shanghai East Hospital, Shanghai Tongji University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DFSC-2023(CR)-01
Identifier Type: -
Identifier Source: org_study_id
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