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Study of Descartes-30 in Acute Respiratory Distress Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04524962
Recruitment Status : Recruiting
First Posted : August 24, 2020
Last Update Posted : February 8, 2023
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Covid19 Biological: Descartes 30 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 23, 2021
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : May 2024

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

Primary Outcome Measures :
  1. To assess the safety of Descartes-30 in patients with moderate-to-severe ARDS. [ Time Frame: 2 years ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04524962

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Contact: Hafsa Kamboh, MD 3013488698 trials@cartesiantx.com

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United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Kim Sprenger         
Principal Investigator: Alejandro Comellas, MD         
United States, Maryland
University of Maryland Medical Center Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Thelma Harrington         
Principal Investigator: Avelino Verceles, MD         
Sponsors and Collaborators
Cartesian Therapeutics
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Responsible Party: Cartesian Therapeutics
ClinicalTrials.gov Identifier: NCT04524962    
Other Study ID Numbers: DC30-1A
First Posted: August 24, 2020    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury