Safety and the Efficacy of MesenCure for the Treatment of Pulmonary Manifestations of COVID-19

Phase 1

Completed

• Conditions: Covid19
• Interventions: Biological: MesenCure

• Registration Number: NCT04716998
• Lead Sponsor: BonusBio Group Ltd

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 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 Timeline

• Status Verified: 2021-01
• Study Start: 2021-01-14
• Study First Submitted: 2021-01-17
• Study First Submitted QC: 2021-01-19
• Study First Posted: 2021-01-20
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Last Update Submitted: 2023-10-05
• Last Update Posted: 2023-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patients are able and agree to sign informed consent form before any study-specific procedure.
2. Males or females, age range 18-80.
3. Female subjects are eligible only if of non-child bearing potential.
4. Documented COVID19
5. O2 Saturation of ≤93%
6. Stable hemodynamic condition (blood pressure of systolic <180mm Hg and diastolic <110mm Hg)
7. Evidence of COVID19-related pulmonary infiltrates on chest X-ray/thoracic tomography.

Exclusion Criteria

General:

1. Pregnant or breast-feeding females.
2. History of drug abuse.
3. Heavy smokers (above 2 packages a day).
4. Subjects incapable of giving consent.

Background medical conditions:

1. Known history of any significant medical disorder, which in the investigator's judgment contraindicates the subject's participation.
2. 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).
3. Known autoimmune diseases.
4. Received any investigational drug within 30 days prior to screening day (Visit 1) (Remdesivir is not considered investigational, and is not an exclusion criteria).
5. Immunocompromised condition from any reason, at screening.
6. Abnormal clinically significant laboratory test findings, as per the investigator's judgment.
7. Poorly controlled diabetic subjects (HbA1c > 9%).
8. Known active lung malignancy.

Concomitant treatment:

1. Currently treated with Immunosuppressive agents other than corticosteroids used for treating COVID19.
2. Treatment for cancer (i.e. chemotherapy or radiotherapy treatment) within the last 12 months.

Hypersensitivity:

1. Known history of hypersensitivity to Dextran-40 (HypoThermosol®).
2. Known history of hypersensitivity to Human Serum Albumin.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MesenCure treatment	MesenCure	Clinical interventions: Health questionnaire, respiratory rate, heart rate, blood pressure, RA O2 saturation, x-ray. Blood tests: leukocyte and lymphocyte count, CRP, D-Dimer, renal and liver function, optional: cytokine levels.

Primary Outcome Measures

Name	Time	Method
Safety of Mesencure	30 days	No treatment-related adverse reactions

Secondary Outcome Measures

Name	Time	Method
Reduction of CRP	14 days	Reduction compared to day 0
Elevation of lymphocytes level	14 days	Elevation compared to day 0
Improvement of health questionnaire	21 days	Improvement compared to day 0
improvement in pulmonary infiltrates/ pulmonary congestion	30 days	Improvement compared to day 0
Reduced hospitalization duration	30 days	Reduced compared to clinical site matching historical data
Improvement in RA-O2 saturation	14 days	Elevation to 94% and above

Trial Locations

Locations (3)

Rambam Health campus; 🇮🇱 Haifa, Israel

Kaplan Medical Center; 🇮🇱 Rehovot, Israel

BARUCH PADEH Medical Center, Poriya; 🇮🇱 Tiberias, Israel