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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02020590 | Phase 1/2a Study on Allogeneic Osteoblastic Cells Implantation in Delayed-Union Fractures | PHASE1 | COMPLETED | 25 | — | — | Feb 1, 2014 | Jan 30, 2020 | Nov 10, 2021 | - | — |
The success of the study will be based on the percentage of treated patients (ALLOB®) not failing under treatment. A patient will be considered as failed under treatment if, at Month 6: - He/she had a rescue surgery Or - The Global Disease Evaluation score (VAS) as perceived by the patient has not improved by at least 25% and the Tomographic Union Score (TUS) as assessed by CT scan has not increased by at least two points (versus baseline).
| Arm | Type | Description |
|---|---|---|
| ALLOB® Implantation | EXPERIMENTAL | One arm: ALLOB® Implantation |
| Name | Type | Description |
|---|---|---|
| ALLOB® implantation | DRUG | Each patient will undergo a single administration of ALLOB® into the delayed-union site under anesthesia. |
Inclusion Criteria: * Patient (or patient's legally acceptable representative) capable to provide a written, dated, and signed informed consent prior to any study related procedure * Non-infected delayed-union fracture of a long bone of minimum 3 months and maximum 7 months (+/- 2 weeks) Exclusion...