Status:
COMPLETED
Safety and the Efficacy of MesenCure for the Treatment of Pulmonary Manifestations of COVID-19
Lead Sponsor:
BonusBio Group Ltd
Conditions:
Covid19
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
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
Detailed Description
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 radio...
Eligibility Criteria
Inclusion
- Patients are able and agree to sign informed consent form before any study-specific procedure.
- Males or females, age range 18-80.
- Female subjects are eligible only if of non-child bearing potential.
- Documented COVID19
- O2 Saturation of ≤93%
- Stable hemodynamic condition (blood pressure of systolic \<180mm Hg and diastolic \<110mm Hg)
- Evidence of COVID19-related pulmonary infiltrates on chest X-ray/thoracic tomography.
Exclusion
- General:
- Pregnant or breast-feeding females.
- History of drug abuse.
- Heavy smokers (above 2 packages a day).
- Subjects incapable of giving consent.
- Background medical conditions:
- Known history of any significant medical disorder, which in the investigator's judgment contraindicates the subject's participation.
- History of significant heart diseases, renal failure (estimated GFR of \<30 ml/min/1.73 m2 at screening), or hepatic disease (hepatic insufficiency classified as Child-Pugh B or C).
- Known autoimmune diseases.
- Received any investigational drug within 30 days prior to screening day (Visit 1) (Remdesivir is not considered investigational, and is not an exclusion criteria).
- Immunocompromised condition from any reason, at screening.
- Abnormal clinically significant laboratory test findings, as per the investigator's judgment.
- Poorly controlled diabetic subjects (HbA1c \> 9%).
- Known active lung malignancy.
- Concomitant treatment:
- Currently treated with Immunosuppressive agents other than corticosteroids used for treating COVID19.
- Treatment for cancer (i.e. chemotherapy or radiotherapy treatment) within the last 12 months.
- Hypersensitivity:
- Known history of hypersensitivity to Dextran-40 (HypoThermosol®).
- Known history of hypersensitivity to Human Serum Albumin.
Key Trial Info
Start Date :
January 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04716998
Start Date
January 14 2021
End Date
January 31 2022
Last Update
August 12 2025
Active Locations (3)
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1
Kaplan Medical Center
Rehovot, Israel, Israel, 7661041
2
BARUCH PADEH Medical Center, Poriya
Tiberias, Israel, Israel, 15208
3
Rambam Health campus
Haifa, Israel, 3109601