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ALLOB implantation · 1 trial · 1 indication
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...
ALLOB implantation is an investigational cell therapy being studied for the treatment of long bone delayed-union fracture, a condition where a broken bone fails to heal within the expected timeframe. It is intended for patients aged 18 years and older. The therapy is currently in clinical development and has not been approved by regulatory authorities.
ALLOB implantation is being developed by Bone Biologics Corp, a company publicly traded under the ticker symbol BBLG. The company is conducting clinical research to evaluate the safety and efficacy of this investigational therapy for long bone delayed-union fracture.
ALLOB implantation is in Phase 1 clinical development. A Phase 1/2a study has been completed, involving 25 participants with long bone delayed-union fracture. The therapy remains investigational and is not yet approved for commercial use.
ALLOB implantation has been studied in one clinical trial registered as NCT02020590, titled 'Phase 1/2a Study on Allogeneic Osteoblastic Cells Implantation in Delayed-Union Fractures.' This trial has been completed and enrolled 25 participants with long bone delayed-union fracture.
ALLOB implantation refers to the implantation of allogeneic osteoblastic cells, which are bone-forming cells derived from a donor. The clinical trial NCT02020590 specifically evaluates the implantation of these cells for treating delayed-union fractures. The therapy is being developed by Bone Biologics Corp.