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

NCT04716998 | Completed Phase 1

• 1 other identifier: CP-MCS-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Safety of Mesencure

  No treatment-related adverse reactions

  30 days

Secondary Outcomes (6)

• Improvement in RA-O2 saturation

  14 days

• Elevation of lymphocytes level

  14 days

• Reduction of CRP

  14 days

• Improvement of health questionnaire

  21 days

• Reduced hospitalization duration

  30 days

Other Outcomes (2)

• 30-day mortality rate

  30 days

• Progressing to invasive ventilation

  The latest of: four (4) weeks or until patient release from hospital.

Study Arms (2)

MesenCure treatment

EXPERIMENTAL

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.

Biological: MesenCure

Retrospective control group

NO INTERVENTION

A retrospective control group based on historical data of 150 matching subjects meeting the eligibility criteria and treated with SOC alone was included, following algorithmic stratifications against the treatment group based on gender, age, and comorbidities. The control group consisted of patients hospitalized during the same year as the treatment group and in the same medical centers as the treatment group patients. The control group patients closely resembled those in the treatment group, with similar or lower ordinal clinical scores and frequencies of comorbidities, helping to avoid bias in favor of the treatment group.

Interventions

MesenCure BIOLOGICAL

Three administrations of MesenCure in addition to standard care

MesenCure treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• BonusBio Group Ltd: lead

Study Sites (3)

Kaplan Medical Center

Rehovot, Israel, 7661041, Israel

Location

BARUCH PADEH Medical Center, Poriya

Tiberias, Israel, 15208, Israel

Location

Rambam Health campus

Haifa, 3109601, Israel

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Shadi Hamoud, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The treatment group consisted of 50 patients, treated with MesenCure in addition to the standard of care (SoC). A retrospective control group based on historical data of 150 matching subjects meeting the eligibility criteria and treated with SoC alone was included, following algorithmic stratifications against the treatment group based on gender, age, and comorbidities. The control group consisted of patients hospitalized during the same year as the treatment group and in the same medical centers as the treatment group patients. The control group patients closely resembled those in the treatment group, with similar or lower ordinal clinical scores and frequencies of comorbidities, helping to avoid bias in favor of the treatment group.

Study Record Dates

• First Submitted: January 17, 2021
• First Posted: January 20, 2021
• Study Start: January 14, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (3)