A Controlled Study to Evaluate the Efficacy of Allogeneic MesenCure for the Treatment of Patients With ARDS

BonusBio Group Ltd0 sites300 target enrollmentApril 1, 2026

ConditionsARDS

InterventionsMesenCure Placebo

DrugsMesenCure

Overview

Phase: Phase 3
Intervention: MesenCure
Conditions: ARDS
Sponsor: BonusBio Group Ltd
Enrollment: 300
Primary Endpoint: CRP reduction
Status: Not yet recruiting
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The efficacy of the allogeneic cell-therapy product MesenCure in addition to standard of care will be evaluated in comparison to placebo control in 300 moderate to severe Covid patients

Registry

clinicaltrials.gov

Start Date

April 1, 2026

End Date

October 1, 2028

Last Updated

8 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

BonusBio Group Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients are able and agree to sign informed consent form before any study-specific procedure.
•Males or females, age range 18-
•Documented ARDS
•RA-O2 Saturation of ≤93% and/or Evidence of COVID19-related pulmonary infiltrates on chest X-ray/thoracic tomography
•Stable hemodynamic condition (blood pressure of systolic \<180mm Hg and diastolic \<110mm Hg)

Exclusion Criteria

•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 advanced congestive heart failure or active acute myocardial infarction (AMI), 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.