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

ARDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05497401
• Other study ID #: MCS-03
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 2024
• Est. completion date: July 2026

Study information

• Verified date: September 2023
• Source: BonusBio Group Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: July 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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. Documented ARDS

4. RA-O2 Saturation of =93% and/or Evidence of COVID19-related pulmonary infiltrates on chest X-ray/thoracic tomography

5. Stable hemodynamic condition (blood pressure of systolic <180mm Hg and diastolic <110mm Hg) 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 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).

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.

2. Known history of hypersensitivity to Human Serum Albumin.

Related Conditions & MeSH terms

• ARDS

Intervention

Biological:
• MesenCure
Enhanced mesenchymal cell-based product

Other:
• Placebo
Saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BonusBio Group Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		1 month
Primary	CRP reduction	Blood CRP is measured in mg/dL	14 days
Primary	Invasive ventilation		1 month