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| ID | Type | Description | Link |
|---|---|---|---|
| 5R44HL158446 | U.S. NIH Grant/Contract | View source | |
| 2021-MSCRFCL-5 | Other Grant/Funding Number | Maryland Stem Cell Research Foundation |
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Phase 1 enrollment completed. Further clinical development terminated
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Emergency study to test the safety of Descartes-30 cells in patients with moderate-to-severe acute respiratory distress syndrome (ARDS) AND COVID-19
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Descartes 30 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Descartes 30 | Biological | Mesenchymal Stem Cells or MSCs RNA-engineered to secrete a combination of DNases. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States | ||
| University of Maryland Medical Center Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Descartes 30: Dose Level 1 | Participants were administered 100 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2. |
| FG001 | Descartes-30: Dose Level 2 | Participants were administered 300 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2. |
| FG002 | Descartes-30: Dose Level 3 | Participants were administered 600 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2. |
| FG003 | Descartes-30: Dose Level 4 Cells/Infusion | Participants were administered 1200 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Descartes 30 Dose Level 1 | Participants were administered 100 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2. |
| BG001 | Descartes 30 Dose Level 2 | Participants were administered 300 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Number | treatment related adverse events | 3 months |
|
Through study completion, up to 3 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Descartes 30: Dose Level 1 | Participants were administered 100 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Immune system disorders | Non-systematic Assessment | Not related to Descartes-30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment | Possibly related to Descartes-30 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hafsa Kamboh | Cartesian Therapeutics, Inc. | 4127585340 | hafsa@cartesiantx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 14, 2022 | Oct 23, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D011024 | Pneumonia, Viral |
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| Baltimore |
| Maryland |
| 21201 |
| United States |
| BG002 | Descartes 30 Dose Level 3 | Participants were administered 600 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2. |
| BG003 | Descartes 30 Dose Level 4 | Participants were administered 1200 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Descartes-30: Dose Level 3 |
Participants were administered 600 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2. |
| OG003 | Descartes-30: Dose Level 4 | Participants were administered 1200 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2. |
|
|
| 2 |
| 3 |
| 2 |
| 3 |
| 2 |
| 3 |
| EG001 | Descartes 30: Dose Level 2 | Participants were administered 300 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2. | 2 | 3 | 0 | 3 | 3 | 3 |
| EG002 | Descartes-30: Dose Level 3 | Participants were administered 600 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2. | 2 | 5 | 3 | 5 | 5 | 5 |
| EG003 | Descartes-30: Dose Level 4 | Participants were administered 1200 million cells of Descartes-30 via intravenous catheter on Days 0, 1, 2. | 0 | 1 | 0 | 1 | 0 | 1 |
|
| Intubation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Not related to Descartes-30 |
|
| Cardiac Arrest | Cardiac disorders | Non-systematic Assessment | Not related to Descartes-30 |
|
| Cardiopulmonary arrest | Cardiac disorders | Non-systematic Assessment | Not related to Descartes-30 |
|
| Acute kidney Injury | Renal and urinary disorders | Non-systematic Assessment | Not related to Descartes-30 |
|
| Acute leg ischemia | Blood and lymphatic system disorders | Non-systematic Assessment | Not related to Descartes-30 |
|
|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment | Possibly related to Descartes-30 |
|
| Fever | Immune system disorders | Non-systematic Assessment | Possibly related to Descartes-30 |
|
| Blood stream infection | Blood and lymphatic system disorders | Non-systematic Assessment | Not related to Descartes-30 |
|
| Insomnia | Psychiatric disorders | Non-systematic Assessment | Not related to Descartes-30 |
|
| Sepsis | Infections and infestations | Non-systematic Assessment | Not related to Descartes-30 |
|
| Mucosal bleeding | Infections and infestations | Non-systematic Assessment | Not related to Descartes-30 |
|
| MRSA pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Not related to Descartes-30 |
|
| UTI | Renal and urinary disorders | Non-systematic Assessment | Not related to Descartes-30 |
|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Not related to Descartes-30 |
|
| Steroid Induced hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment | Not related to Descartes-30 |
|
| ventricular tachycardia | Cardiac disorders | Non-systematic Assessment | Not related to Descartes-30 |
|
| Hyperkalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | Non-systematic Assessment | Not related to Descartes-30 |
|
| Creatinine increased | Investigations | Non-systematic Assessment | Not related to Descartes-30 |
|
| INR increased | Investigations | Non-systematic Assessment | Not related to Descartes-30 |
|
| AST increased | Investigations | Non-systematic Assessment | Not related to Descartes-30 |
|
| ALT increased | Investigations | Non-systematic Assessment |
|
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Not related to Descartes-30 |
|
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| D011014 |
| Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |