Trial Outcomes & Findings for Study of Descartes-30 in Acute Respiratory Distress Syndrome (NCT NCT04524962)
NCT ID: NCT04524962
Last Updated: 2024-10-29
Results Overview
Safety will be determined principally by assessment of adverse events (AEs) and serious adverse events (SAEs).
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
3 months
Results posted on
2024-10-29
Participant Flow
Participant milestones
| Measure |
Descartes 30: Dose Level 1
Participants were administered 100 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2.
|
Descartes-30: Dose Level 2
Participants were administered 300 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2.
|
Descartes-30: Dose Level 3
Participants were administered 600 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2.
|
Descartes-30: Dose Level 4 Cells/Infusion
Participants were administered 1200 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
5
|
1
|
|
Overall Study
COMPLETED
|
3
|
3
|
5
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Descartes-30 in Acute Respiratory Distress Syndrome
Baseline characteristics by cohort
| Measure |
Descartes 30 Dose Level 1
n=3 Participants
Participants were administered 100 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2.
|
Descartes 30 Dose Level 2
n=3 Participants
Participants were administered 300 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2.
|
Descartes 30 Dose Level 3
n=5 Participants
Participants were administered 600 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2.
|
Descartes 30 Dose Level 4
n=1 Participants
Participants were administered 1200 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Region of Enrollment
Turkey
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 3 monthsSafety will be determined principally by assessment of adverse events (AEs) and serious adverse events (SAEs).
Outcome measures
| Measure |
Descartes 30: Dose Level 1
n=3 Participants
Participants were administered 100 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2.
|
Descartes-30: Dose Level 2
n=3 Participants
Participants were administered 300 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2.
|
Descartes-30: Dose Level 3
n=5 Participants
Participants were administered 600 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2.
|
Descartes-30: Dose Level 4
n=1 Participants
Participants were administered 1200 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2.
|
|---|---|---|---|---|
|
To Assess the Safety of Descartes-30 in Patients With Moderate-to-severe ARDS.
|
1 treatment related adverse events
|
1 treatment related adverse events
|
3 treatment related adverse events
|
0 treatment related adverse events
|
Adverse Events
Descartes 30: Dose Level 1
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
Descartes 30: Dose Level 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Descartes-30: Dose Level 3
Serious events: 3 serious events
Other events: 5 other events
Deaths: 2 deaths
Descartes-30: Dose Level 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Descartes 30: Dose Level 1
n=3 participants at risk
Participants were administered 100 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2.
|
Descartes 30: Dose Level 2
n=3 participants at risk
Participants were administered 300 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2.
|
Descartes-30: Dose Level 3
n=5 participants at risk
Participants were administered 600 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2.
|
Descartes-30: Dose Level 4
n=1 participants at risk
Participants were administered 1200 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2.
|
|---|---|---|---|---|
|
Immune system disorders
Sepsis
|
33.3%
1/3 • Through study completion, up to 3 months.
|
0.00%
0/3 • Through study completion, up to 3 months.
|
0.00%
0/5 • Through study completion, up to 3 months.
|
0.00%
0/1 • Through study completion, up to 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Intubation
|
33.3%
1/3 • Through study completion, up to 3 months.
|
0.00%
0/3 • Through study completion, up to 3 months.
|
0.00%
0/5 • Through study completion, up to 3 months.
|
0.00%
0/1 • Through study completion, up to 3 months.
|
|
Cardiac disorders
Cardiac Arrest
|
33.3%
1/3 • Through study completion, up to 3 months.
|
0.00%
0/3 • Through study completion, up to 3 months.
|
0.00%
0/5 • Through study completion, up to 3 months.
|
0.00%
0/1 • Through study completion, up to 3 months.
|
|
Cardiac disorders
Cardiopulmonary arrest
|
0.00%
0/3 • Through study completion, up to 3 months.
|
0.00%
0/3 • Through study completion, up to 3 months.
|
20.0%
1/5 • Through study completion, up to 3 months.
|
0.00%
0/1 • Through study completion, up to 3 months.
|
|
Renal and urinary disorders
Acute kidney Injury
|
0.00%
0/3 • Through study completion, up to 3 months.
|
0.00%
0/3 • Through study completion, up to 3 months.
|
20.0%
1/5 • Through study completion, up to 3 months.
|
0.00%
0/1 • Through study completion, up to 3 months.
|
|
Blood and lymphatic system disorders
Acute leg ischemia
|
0.00%
0/3 • Through study completion, up to 3 months.
|
0.00%
0/3 • Through study completion, up to 3 months.
|
20.0%
1/5 • Through study completion, up to 3 months.
|
0.00%
0/1 • Through study completion, up to 3 months.
|
Other adverse events
| Measure |
Descartes 30: Dose Level 1
n=3 participants at risk
Participants were administered 100 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2.
|
Descartes 30: Dose Level 2
n=3 participants at risk
Participants were administered 300 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2.
|
Descartes-30: Dose Level 3
n=5 participants at risk
Participants were administered 600 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2.
|
Descartes-30: Dose Level 4
n=1 participants at risk
Participants were administered 1200 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
MRSA pneumonia
|
33.3%
1/3 • Through study completion, up to 3 months.
|
0.00%
0/3 • Through study completion, up to 3 months.
|
0.00%
0/5 • Through study completion, up to 3 months.
|
0.00%
0/1 • Through study completion, up to 3 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Through study completion, up to 3 months.
|
0.00%
0/3 • Through study completion, up to 3 months.
|
20.0%
1/5 • Number of events 1 • Through study completion, up to 3 months.
|
0.00%
0/1 • Through study completion, up to 3 months.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • Through study completion, up to 3 months.
|
0.00%
0/3 • Through study completion, up to 3 months.
|
20.0%
1/5 • Number of events 2 • Through study completion, up to 3 months.
|
0.00%
0/1 • Through study completion, up to 3 months.
|
|
Immune system disorders
Fever
|
33.3%
1/3 • Number of events 1 • Through study completion, up to 3 months.
|
33.3%
1/3 • Number of events 1 • Through study completion, up to 3 months.
|
0.00%
0/5 • Through study completion, up to 3 months.
|
0.00%
0/1 • Through study completion, up to 3 months.
|
|
Blood and lymphatic system disorders
Blood stream infection
|
33.3%
1/3 • Number of events 2 • Through study completion, up to 3 months.
|
0.00%
0/3 • Through study completion, up to 3 months.
|
0.00%
0/5 • Through study completion, up to 3 months.
|
0.00%
0/1 • Through study completion, up to 3 months.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Through study completion, up to 3 months.
|
0.00%
0/3 • Through study completion, up to 3 months.
|
0.00%
0/5 • Through study completion, up to 3 months.
|
0.00%
0/1 • Through study completion, up to 3 months.
|
|
Infections and infestations
Sepsis
|
33.3%
1/3 • Through study completion, up to 3 months.
|
33.3%
1/3 • Through study completion, up to 3 months.
|
40.0%
2/5 • Through study completion, up to 3 months.
|
0.00%
0/1 • Through study completion, up to 3 months.
|
|
Infections and infestations
Mucosal bleeding
|
33.3%
1/3 • Through study completion, up to 3 months.
|
0.00%
0/3 • Through study completion, up to 3 months.
|
0.00%
0/5 • Through study completion, up to 3 months.
|
0.00%
0/1 • Through study completion, up to 3 months.
|
|
Renal and urinary disorders
UTI
|
33.3%
1/3 • Through study completion, up to 3 months.
|
0.00%
0/3 • Through study completion, up to 3 months.
|
0.00%
0/5 • Through study completion, up to 3 months.
|
0.00%
0/1 • Through study completion, up to 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
33.3%
1/3 • Through study completion, up to 3 months.
|
0.00%
0/3 • Through study completion, up to 3 months.
|
0.00%
0/5 • Through study completion, up to 3 months.
|
0.00%
0/1 • Through study completion, up to 3 months.
|
|
Metabolism and nutrition disorders
Steroid Induced hyperglycemia
|
0.00%
0/3 • Through study completion, up to 3 months.
|
33.3%
1/3 • Through study completion, up to 3 months.
|
0.00%
0/5 • Through study completion, up to 3 months.
|
0.00%
0/1 • Through study completion, up to 3 months.
|
|
Cardiac disorders
ventricular tachycardia
|
0.00%
0/3 • Through study completion, up to 3 months.
|
33.3%
1/3 • Through study completion, up to 3 months.
|
0.00%
0/5 • Through study completion, up to 3 months.
|
0.00%
0/1 • Through study completion, up to 3 months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • Through study completion, up to 3 months.
|
0.00%
0/3 • Through study completion, up to 3 months.
|
20.0%
1/5 • Through study completion, up to 3 months.
|
0.00%
0/1 • Through study completion, up to 3 months.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • Through study completion, up to 3 months.
|
0.00%
0/3 • Through study completion, up to 3 months.
|
20.0%
1/5 • Through study completion, up to 3 months.
|
0.00%
0/1 • Through study completion, up to 3 months.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • Through study completion, up to 3 months.
|
0.00%
0/3 • Through study completion, up to 3 months.
|
20.0%
1/5 • Through study completion, up to 3 months.
|
0.00%
0/1 • Through study completion, up to 3 months.
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • Through study completion, up to 3 months.
|
33.3%
1/3 • Through study completion, up to 3 months.
|
60.0%
3/5 • Through study completion, up to 3 months.
|
0.00%
0/1 • Through study completion, up to 3 months.
|
|
Investigations
INR increased
|
0.00%
0/3 • Through study completion, up to 3 months.
|
0.00%
0/3 • Through study completion, up to 3 months.
|
20.0%
1/5 • Through study completion, up to 3 months.
|
0.00%
0/1 • Through study completion, up to 3 months.
|
|
Investigations
AST increased
|
0.00%
0/3 • Through study completion, up to 3 months.
|
0.00%
0/3 • Through study completion, up to 3 months.
|
20.0%
1/5 • Through study completion, up to 3 months.
|
0.00%
0/1 • Through study completion, up to 3 months.
|
|
Investigations
ALT increased
|
0.00%
0/3 • Through study completion, up to 3 months.
|
0.00%
0/3 • Through study completion, up to 3 months.
|
20.0%
1/5 • Through study completion, up to 3 months.
|
0.00%
0/1 • Through study completion, up to 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/3 • Through study completion, up to 3 months.
|
0.00%
0/3 • Through study completion, up to 3 months.
|
20.0%
1/5 • Through study completion, up to 3 months.
|
0.00%
0/1 • Through study completion, up to 3 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place