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Study of Descartes-30 in Acute Respiratory Distress Syndrome

Primary Purpose

Acute Respiratory Distress Syndrome, Covid19

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Descartes 30

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Iowa Hospitals and ClinicsRecruiting
University of Maryland Medical Center Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Descartes 30

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04524962

First Posted

August 19, 2020

Last Updated

February 6, 2023

Sponsor

Cartesian Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT04524962

Brief Title

Study of Descartes-30 in Acute Respiratory Distress Syndrome

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 23, 2021 (Actual)

Primary Completion Date

May 2024 (Anticipated)

Study Completion Date

May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cartesian Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Respiratory Distress Syndrome, Covid19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Descartes 30

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Descartes 30

Intervention Description

Mesenchymal Stem Cells or MSCs RNA-engineered to secrete a combination of DNases.

Primary Outcome Measure Information:

Title

To assess the safety of Descartes-30 in patients with moderate-to-severe ARDS.

Description

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hafsa Kamboh, MD

Phone

3013488698

trials@cartesiantx.com

Facility Information:

Facility Name

University of Iowa Hospitals and Clinics

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kim Sprenger

First Name & Middle Initial & Last Name & Degree

Alejandro Comellas, MD

Facility Name

University of Maryland Medical Center Medical Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thelma Harrington

First Name & Middle Initial & Last Name & Degree

Avelino Verceles, MD

12. IPD Sharing Statement

Learn more about this trial

Study of Descartes-30 in Acute Respiratory Distress Syndrome

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