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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-based therapy being developed by Bone Biologics Corp for long bone delayed-union fractures, a condition where a broken long bone heals more slowly than expected. It is a small molecule modality product and has completed a Phase 1/2a clinical trial.
ALLOB implantation is being studied for the treatment of long bone delayed-union fractures, which are fractures of the long bones that are slow to heal. The program is in the musculoskeletal therapeutic area and has completed one clinical trial in this indication.
ALLOB implantation is being developed by Bone Biologics Corp, which trades under the ticker BBLG. The company is the sponsor of the clinical program for this long bone delayed-union fracture therapy.
ALLOB implantation is in Phase 1 development. It has completed one Phase 1/2a clinical trial, and no active trials are currently listed. It is an investigational product and is not approved for commercial use.
ALLOB implantation has been studied in one completed clinical trial, NCT02020590, titled a Phase 1/2a Study on Allogeneic Osteoblastic Cells Implantation in Delayed-Union Fractures. The trial enrolled 25 participants aged 18 years and older and was an uncontrolled study.
Yes, ALLOB implantation is also written as ALLOB, with the registered mark, and both names refer to the same investigational product from Bone Biologics Corp. The alternative spelling appears in the product's formal name, ALLOB implantation.