Study of Descartes-30 in Acute Respiratory Distress Syndrome

Phase 1

Terminated

• Conditions: Acute Respiratory Distress Syndrome; Covid19
• Interventions: Biological: Descartes 30

• Registration Number: NCT04524962
• Lead Sponsor: Cartesian Therapeutics

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-19
• Study First Submitted QC: 2020-08-20
• Study First Posted: 2020-08-24
• Study Start: 2021-02-23
• Primary Completion: 2022-09-09
• Study Completion: 2023-09-09
• Status Verified: 2024-10
• Results First Submitted: 2024-10-23
• Results First Submitted QC: 2024-10-26
• Last Update Submitted: 2024-10-26
• Results First Posted: 2024-10-29
• Last Update Posted: 2024-10-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Descartes 30	Descartes 30	-

Primary Outcome Measures

Name	Time	Method
To Assess the Safety of Descartes-30 in Patients With Moderate-to-severe ARDS.	3 months	Safety will be determined principally by assessment of adverse events (AEs) and serious adverse events (SAEs).

Trial Locations

Locations (2)

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

University of Maryland Medical Center Medical Center; 🇺🇸 Baltimore, Maryland, United States