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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 : Not yet recruiting
First Posted : August 24, 2020
Last Update Posted : September 3, 2020
Sponsor:
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
Estimated Study Start Date : September 15, 2020
Estimated Primary Completion Date : September 25, 2021
Estimated Study Completion Date : September 25, 2022


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
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.

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


Contacts
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Contact: Adam S Chowdhury, MD, MBA 3026486497 trials@cartesiantx.com

Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Contact: Bruce D Levy, MD         
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Contact: Ryan Kennedy, 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: September 3, 2020
Last Verified: September 2020

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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, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury