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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07580716 | Intra-Articular Allocetra in Patients With Primary Knee Osteoarthritis | PHASE2 | RECRUITING | 270 | — | — | May 1, 2026 | Apr 1, 2028 | May 20, 2026 | 17 | United States, Denmark +1 |
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.
| 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. |
| 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...