Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Allocetra-OTS
Allocetra · 5 trials · 10 indications
The change from baseline of the WOMAC Pain score at 3 months between Allocetra and Placebo. Total Pain score ranges from 0 (No pain) to 50 (Extreme pain).
The change from baseline for the WOMAC Function score at 3 months between Allocetra and Placebo. Total Function score ranges from 0 (No difficulty) to 170 (Extreme difficulty).
Incidence and severity of Adverse Events (AEs) up to 6 months. AE incidence will be represented as % per study group and AE severity will be represented as mild, moderate or severe.
Change from baseline in SOFA score throughout 28 days
Number and severity of AEs and SAEs throughout 28 days follow up period
Number and severity of adverse events (AEs), serious adverse events (SAEs) and treatment disruptions/ discontinuations throughout the study from Day 0 and up to 6 months following the last injection
Incidence rates of any Adverse Events (AE), Serious Adverse Events (SAE) and fatal SAE
| Arm | Type | Description |
|---|---|---|
| Allocetra | EXPERIMENTAL | Three intra-articular injections of Allocetra at a selected dose, into the index knee. |
| Placebo | PLACEBO_COMPARATOR | Three intra-articular injections of placebo into the index knee. |
| Cohort 1 | PLACEBO_COMPARATOR | Single IV dose of placebo solution |
| Cohort 2 | EXPERIMENTAL | Single IV dose of 5x10\^9 Allocetra-OTS cells in suspension |
| Cohort 3 | EXPERIMENTAL | Single IV dose of 10x10\^9 Allocetra-OTS cells in suspension |
| Cohort 4 | EXPERIMENTAL | Single or two doses of 10x10\^9 Allocetra-OTS cells in suspension |
| Safety run-in phase - Allocetra increasing dose | OTHER | An open-label dose escalation phase to characterize the safety and tolerability of Allocetra injections to the knee in different doses and select the Allocetra dose and regimen for the randomized phase. |
| Randomization phase - Placebo. | PLACEBO_COMPARATOR | Three intra-articular injections of placebo into the index knee. |
| Randomization phase - Allocetra | EXPERIMENTAL | Three intra-articular injections of Allocetra at a selected dose, into the index knee. |
| 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 | DRUG | Allocetra is a cell-based therapy consisting of non-HLA-matched allogeneic peripheral blood mononuclear cells, induced to an apoptotic stable state. |
| Placebo | OTHER | The control used in this study will be placebo. Placebo solution containing all excipients except for the Allocetra cells. |
| Allocetra-OTS | DRUG | Allocetra-OTS is a cell-based therapy consisting of non-HLA-matched allogeneic peripheral blood mononuclear cells, derived from a healthy human donor following a leukapheresis procedure, induced to an apoptotic stable state and suspended in a solution containing DMSO. |
Inclusion Criteria: Participants must meet all of the inclusion criteria listed below to be eligible for the study: 1. Age 64 years or above. 2. Diagnosis of primary femorotibial knee OA. 3. Radiographic evidence of knee OA defined as Kellgren-Lawrence (KL) grade 2 or 3 in the index knee. 4. Parti...
Allocetra is an investigational small molecule therapy developed by Enlivex Ltd. It is being studied in knee osteoarthritis and in sepsis-related organ dysfunction. It is not approved for any indication and remains in clinical development, with trials conducted in the United States, Denmark, Poland, Israel, Moldova, Belgium, France, the Netherlands, and Spain.
Allocetra is being studied as an intra-articular injection for primary knee osteoarthritis, including end-stage disease. Trials have enrolled adults with knee osteoarthritis, with minimum ages ranging from 18 to 64 years depending on the study. The program includes both Phase 1 and Phase 2 trials, and the osteoarthritis indication remains investigational.
Allocetra is developed by Enlivex Ltd., which trades under the ticker ENLV. The company sponsors the clinical program, including the intra-articular knee osteoarthritis studies and the completed Phase 2 sepsis trial. Allocetra-OTS is the name used for the same asset in several of these studies.
Allocetra is in clinical development across Phase 1 and Phase 2 studies. The knee osteoarthritis program includes an active Phase 2 trial, a Phase 1 trial, and an early Phase 1 safety study. A Phase 2 sepsis trial has been completed. Allocetra is investigational and has not been approved by the FDA.
Allocetra trials include NCT07580716, a recruiting Phase 2 study of intra-articular Allocetra in primary knee osteoarthritis with 182 patients; NCT06233474, an active Phase 1 knee osteoarthritis study; NCT06208241, an early Phase 1 safety study in end-stage knee osteoarthritis; and NCT04612413, a completed Phase 2 sepsis trial.
Yes, Allocetra-OTS is an alternative name for Allocetra. Enlivex Ltd. uses the Allocetra-OTS designation in several studies, including the early Phase 1 end-stage knee osteoarthritis safety trial and the completed Phase 2 sepsis trial in adults with organ failure. Both names refer to the same investigational asset.