Study of Descartes-30 in Acute Respiratory Distress Syndrome

NCT04524962 | Terminated Phase 1 Results FDA Drug

• 3 other identifiers: DC30-1A5R44HL1584462021-MSCRFCL-5
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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

Conditions

Acute Respiratory Distress Syndrome; Covid19

Outcome Measures

Primary Outcomes (1)

• To Assess the Safety of Descartes-30 in Patients With Moderate-to-severe ARDS.

  Safety will be determined principally by assessment of adverse events (AEs) and serious adverse events (SAEs).

  3 months

Study Arms (1)

Descartes 30

EXPERIMENTAL

Biological: Descartes 30

Interventions

Descartes 30 BIOLOGICAL

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

Descartes 30

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cartesian Therapeutics: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Maryland Medical Center Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Results Point of Contact

• Title: Hafsa Kamboh
• Organization: Cartesian Therapeutics, Inc.

hafsa@cartesiantx.com

4127585340

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 24, 2020
• Study Start: February 23, 2021
• Primary Completion: September 9, 2022
• Study Completion: September 9, 2023
• Last Updated: October 29, 2024
• Results First Posted: October 29, 2024

Record last verified: 2024-10

Locations

US (2)