Study of Descartes-30 in Acute Respiratory Distress Syndrome

• Sponsor: Cartesian Therapeutics (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04524962
• Collaborator: (none)
• Enrollment: 30
• Locations: 6
• Arm: 1
• Anticipated Duration (Months): 19
• Patients Per Site: 5
• Patients Per Site Per Month: 0.3

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Distress Syndrome; Covid19	Biological: Descartes 30	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I/IIA Study of Descartes-30 in Acute Respiratory Distress Syndrome
• Actual Study Start Date: Feb 23, 2021
• Anticipated Primary Completion Date: Sep 25, 2022
• Anticipated Study Completion Date: Sep 25, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Descartes 30	Biological: Descartes 30; Mesenchymal Stem Cells or MSCs RNA-engineered to secrete a combination of DNases.

Outcome Measures

Primary Outcome Measures

1. To assess the safety of Descartes-30 in patients with moderate-to-severe ARDS. [2 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294-0007
2	University of California-Irvine	Irvine	California	United States	92697
3	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
4	University of Maryland Medical Center Medical Center	Baltimore	Maryland	United States	21201
5	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
6	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104

Sponsors and Collaborators

• Cartesian Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cartesian Therapeutics
• ClinicalTrials.gov Identifier: NCT04524962
• Other Study ID Numbers: DC30-1A
• First Posted: Aug 24, 2020
• Last Update Posted: May 20, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome

Study Results

No Results Posted as of May 20, 2022