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...
Allocetra is an investigational small molecule being developed for knee osteoarthritis, including primary knee osteoarthritis. It is administered intra-articularly, meaning directly into the knee joint. The drug is currently in clinical trials for this condition and has not been approved by the FDA.
Allocetra is being developed by Enlivex Ltd., a biopharmaceutical company traded on the Nasdaq under the ticker ENLV. The company is conducting clinical trials of Allocetra for knee osteoarthritis in multiple countries, including the United States, Denmark, Israel, Poland, and Moldova.
Allocetra is in Phase 1 and Phase 2 clinical trials for knee osteoarthritis. The Phase 1 trial is active but not recruiting, while the Phase 2 trial is currently recruiting participants. The drug has received a Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, but it remains investigational.
Allocetra is being studied in two clinical trials. NCT06233474 is a Phase 1 study of intra-articular Allocetra in knee osteoarthritis, enrolling 160 participants in Denmark, Israel, and Moldova. NCT07580716 is a Phase 2 trial in patients with primary knee osteoarthritis, enrolling 270 participants in the United States, Denmark, and Poland.
Allocetra is not FDA approved. It is an investigational drug currently in Phase 1 and Phase 2 clinical trials for knee osteoarthritis. The FDA has granted it a Regenerative Medicine Advanced Therapy (RMAT) designation, which is intended to expedite development and review of regenerative medicine therapies, but approval has not been granted.
The Allocetra clinical trials are randomized, double-blind, and placebo-controlled. This means participants are randomly assigned to receive either Allocetra or a placebo, and neither the participants nor the researchers know who receives which treatment. The trials enroll adults aged 45 years and older, with the Phase 2 trial requiring participants to be at least 64 years old.