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NCT04524962 Clinical Trial

Study of Descartes-30 in Acute Respiratory Distress Syndrome

Covid19 Clinical Trial

Official title:
Phase I/IIA Study of Descartes-30 in Acute Respiratory Distress Syndrome

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04524962
Other study ID # DC30-1A
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date February 23, 2021
Est. completion date September 9, 2023

Study information
Verified date June 2024
Source Cartesian Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Emergency study to test the safety of Descartes-30 cells in patients with moderate-to-severe acute respiratory distress syndrome (ARDS) AND COVID-19

Recruitment information / eligibility
Status Terminated
Enrollment 12
Est. completion date September 9, 2023
Est. primary completion date September 9, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients must be 18 years of age or older at the time of enrollment - Patient maintains a diagnosis of moderate or severe ARDS according to the Berlin definition of ARDS Exclusion Criteria: - Patient is currently enrolled into another therapeutic clinical trial with an experimental therapy that has not received marketing approval by U.S. FDA. - Patient is in moribund state with expected survival <24 hours.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Descartes 30
Mesenchymal Stem Cells or MSCs RNA-engineered to secrete a combination of DNases.

Locations
Country Name City State
United States University of Maryland Medical Center Medical Center Baltimore Maryland
United States University of Iowa Hospitals and Clinics Iowa City Iowa

Sponsors (1)
Lead Sponsor Collaborator
Cartesian Therapeutics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To assess the safety of Descartes-30 in patients with moderate-to-severe ARDS. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 2 years
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