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Study of Descartes-30 in Acute Respiratory Distress Syndrome

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ClinicalTrials.gov Identifier: NCT04524962
Recruitment Status : Recruiting
First Posted : August 24, 2020
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
Cartesian Therapeutics

Tracking Information
First Submitted Date  ICMJE August 19, 2020
First Posted Date  ICMJE August 24, 2020
Last Update Posted Date February 10, 2021
Actual Study Start Date  ICMJE September 15, 2020
Estimated Primary Completion Date September 25, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Descartes-30 in Acute Respiratory Distress Syndrome
Official Title  ICMJE Phase I/IIA Study of Descartes-30 in Acute Respiratory Distress Syndrome
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Respiratory Distress Syndrome
  • Covid19
Intervention  ICMJE Biological: Descartes 30
Mesenchymal Stem Cells or MSCs RNA-engineered to secrete a combination of DNases.
Study Arms  ICMJE Experimental: Descartes 30
Intervention: Biological: Descartes 30
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 20, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 25, 2022
Estimated Primary Completion Date September 25, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Adam S Chowdhury, MD, MBA 3026486497 trials@cartesiantx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04524962
Other Study ID Numbers  ICMJE DC30-1A
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cartesian Therapeutics
Study Sponsor  ICMJE Cartesian Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cartesian Therapeutics
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP