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Study of Descartes-30 in Acute Respiratory Distress Syndrome

Phase I/IIA Study of Descartes-30 in Acute Respiratory Distress Syndrome

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04524962
Enrollment
12
Registered
2020-08-24
Start date
2021-02-23
Completion date
2023-09-09
Last updated
2024-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome, Covid19

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

Interventions

BIOLOGICALDescartes 30

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

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Cartesian Therapeutics
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
To Assess the Safety of Descartes-30 in Patients With Moderate-to-severe ARDS.3 monthsSafety will be determined principally by assessment of adverse events (AEs) and serious adverse events (SAEs).

Countries

United States

Participant flow

Participants by arm

ArmCount
Descartes 30 Dose Level 1
Participants were administered 100 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2.
3
Descartes 30 Dose Level 2
Participants were administered 300 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2.
3
Descartes 30 Dose Level 3
Participants were administered 600 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2.
5
Descartes 30 Dose Level 4
Participants were administered 1200 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2.
1
Total12

Baseline characteristics

CharacteristicDescartes 30 Dose Level 1Descartes 30 Dose Level 2Descartes 30 Dose Level 3Descartes 30 Dose Level 4Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants1 Participants2 Participants1 Participants4 Participants
Age, Categorical
Between 18 and 65 years
3 Participants2 Participants3 Participants0 Participants8 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants1 Participants1 Participants0 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
3 Participants2 Participants4 Participants1 Participants10 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
3 Participants1 Participants5 Participants1 Participants10 Participants
Region of Enrollment
Turkey
2 Participants0 Participants0 Participants0 Participants2 Participants
Region of Enrollment
United States
1 Participants3 Participants5 Participants1 Participants10 Participants
Sex: Female, Male
Female
2 Participants1 Participants1 Participants0 Participants4 Participants
Sex: Female, Male
Male
1 Participants2 Participants4 Participants1 Participants8 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
2 / 32 / 32 / 50 / 1
other
Total, other adverse events
2 / 33 / 35 / 50 / 1
serious
Total, serious adverse events
2 / 30 / 33 / 50 / 1

Outcome results

Primary

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).

Time frame: 3 months

ArmMeasureValue (NUMBER)
Descartes 30: Dose Level 1To Assess the Safety of Descartes-30 in Patients With Moderate-to-severe ARDS.1 treatment related adverse events
Descartes-30: Dose Level 2To Assess the Safety of Descartes-30 in Patients With Moderate-to-severe ARDS.1 treatment related adverse events
Descartes-30: Dose Level 3To Assess the Safety of Descartes-30 in Patients With Moderate-to-severe ARDS.3 treatment related adverse events
Descartes-30: Dose Level 4To Assess the Safety of Descartes-30 in Patients With Moderate-to-severe ARDS.0 treatment related adverse events

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026