Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Allocetra · 2 trials · 2 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.
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
| 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. |
| 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. |
| 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. |
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...