Not yet recruiting NCT05497401
A Controlled Study to Evaluate the Efficacy of Allogeneic MesenCure for the Treatment of Patients With ARDS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MesenCure, Placebo.
- Who it may be relevant to
- Registry conditions: ARDS. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Interventions
- Biological MesenCure
Enhanced mesenchymal cell-based product - Other Placebo
Saline
Primary outcome measures
- Mortality [Time frame: 1 month]
- CRP reduction [Time frame: 14 days]
- Invasive ventilation [Time frame: 1 month]
Eligibility criteria
Inclusion criteria
- Patients are able and agree to sign informed consent form before any study-specific procedure.
- Males or females, age range 18-80.
- 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
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 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.
- 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.
- Known history of hypersensitivity to Human Serum Albumin.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05497401 · MCS-03