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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00505219 | Ixmyelocel-T Treatment of Patients With Osteonecrosis of the Femoral Head | PHASE3 | COMPLETED | 11 | — | — | Sep 1, 2007 | Dec 1, 2010 | Oct 21, 2019 | 3 | United States |
| Arm | Type | Description |
|---|---|---|
| Ixmyelocel-T | EXPERIMENTAL | Core decompression \& treatment with Tissue Repair Cells (TRCs), demineralized bone matrix bound in autologous plasma |
| Standard of Care Only | ACTIVE_COMPARATOR | Core decompression, demineralized bone matrix bound in autologous plasma, without any TRCs. |
| Name | Type | Description |
|---|---|---|
| Ixmyelocel-T | BIOLOGICAL | Core decompression of the femoral head to remove necrotic tissue with Ixmyelocel-T given to treatment arm only. |
| Standard of Care Only | OTHER | Core decompression of the femoral head to remove necrotic tissue |
Inclusion Criteria: * UPenn (Steinberg) classification of osteonecrosis, inclusive of Stages IIB and IIC. Diagnosis will be based on magnetic resonance imaging (MRI). * Modified index of necrotic extent \< 40 * Idiopathic and non-idiopathic osteonecrosis. * No infection in affected bones at the tim...