Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03925857 | Prevention of Sepsis-related Organ Dysfunction With Allocetra-OTS | PHASE1 | COMPLETED | 10 | — | — | Jan 27, 2019 | Jan 12, 2020 | May 19, 2020 | 1 | Israel |
Incidence rates of any Adverse Events (AE), Serious Adverse Events (SAE) and fatal SAE
| Arm | Type | Description |
|---|---|---|
| Allocetra-OTS | EXPERIMENTAL | Standard of Care (SOC) Drug: One dose Allocetra-OTS 140 140x106 /kg |
| Allocetra-OTS Two doses | EXPERIMENTAL | Standard of Care (SOC) Drug: Two doses Allocetra-OTS 140 140x106 /kg |
| Name | Type | Description |
|---|---|---|
| Allocetra-OTS | BIOLOGICAL | Allocetra-OTS contains allogeneic donor mononuclear enriched cells in the form of a liquid suspension with at least 40% early apoptotic cells. The suspension is prepared with Ringer's lactate solution. |
Inclusion Criteria: * Suspected, presumed or documented infection from any source. * Initiation of antibiotics. * Meets Sepsis 3 criteria: The presence of organ dysfunction as identified by a total SOFA score ≥ 2 points above baseline. * Adult male or female, age between 18 and 85. * GCS of \>13 wi...