An open label clinical study to evaluate the safety and the efficacy of MesenCure, an allogeneic cell therapy product, for the treatment of the pulmonary manifestations in COVID19 patients
Primary endpoint: The IV administration of MesenCure is safe under the following conditions: in subjects hospitalized with COVID19 moderate to severe disease, defined upon clinical situation and radiologic findings. Secondary endpoint: The IV administration of MesenCure is efficacious under the following conditions: Clinical parameters: Health questionnaire, respiratory rate, heart rate, blood pressure, RA O2 saturation, hospitalization duration. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Laboratory findings: leukocyte and lymphocyte count, CRP, D-Dimer, renal and liver function, optional: cytokine levels. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Radiologic findings: pulmonary infiltrates, pleural effusion.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Three administrations of MesenCure in addition to standard care
Kaplan Medical Center
Rehovot, Israel, Israel
BARUCH PADEH Medical Center, Poriya
Tiberias, Israel, Israel
Rambam Health campus
Haifa, Israel
Safety of Mesencure
No treatment-related adverse reactions
Time frame: 30 days
Improvement in RA-O2 saturation
Elevation to 94% and above
Time frame: 14 days
Elevation of lymphocytes level
Elevation compared to day 0
Time frame: 14 days
Reduction of CRP
Reduction compared to day 0
Time frame: 14 days
Improvement of health questionnaire
Improvement compared to day 0
Time frame: 21 days
Reduced hospitalization duration
Reduced compared to clinical site matching historical data
Time frame: 30 days
improvement in pulmonary infiltrates/ pulmonary congestion
Improvement compared to day 0
Time frame: 30 days
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