Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Fracture healing is a complex physiological process caused by interaction of cellular elements, cytokines and signaling proteins, which results in the formation of new bone. There is for now no universally accepted approach to evaluate the progression of fracture healing. Typically, a fracture is considered as a delayed-union when the bone has not united within a period of time that would be considered adequate for bone healing. Delayed-union suggests that union is slow but will eventually occur without additional surgical or non-surgical intervention, whereas non-union is defined as the cessation of all reparative process of healing.
The incidence of impaired healing is estimated to range from 5 to 10% of all long bone fractures, depending on the fracture site, the type and degree of injury, among other factors. Currently the treatment of choice remains bone allograft or autograft. This procedure shows in general good results but requires an invasive surgery of several hours under general anesthesia, followed by a few days of hospitalization. Because of this, major complications have been reported in up to 20-30% of patients.
The present Phase 1/2a study aims at demonstrating the safety and efficacy of ALLOB®, a proprietary population of allogeneic osteoblastic cells, in the treatment of delayed-union fractures of long bones. In this study, delayed-union is defined at the time of screening as an absence of healing of minimum 3 months and maximum 7 months (+/- 2 weeks) after the onset of the fracture.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALLOB® Implantation | Experimental | One arm: ALLOB® Implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALLOB® implantation | Drug | Each patient will undergo a single administration of ALLOB® into the delayed-union site under anesthesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders at 6 Months (Efficacy of ALLOB) | 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). | 6 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34174963 | Derived | Jayankura M, Schulz AP, Delahaut O, Witvrouw R, Seefried L, Berg BV, Heynen G, Sonnet W. Percutaneous administration of allogeneic bone-forming cells for the treatment of delayed unions of fractures: a pilot study. Stem Cell Res Ther. 2021 Jun 26;12(1):363. doi: 10.1186/s13287-021-02432-4. |
Not provided
Not provided
Of the 25 patients enrolled in the study (ICF signature), 22 patients were treated:
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ALLOB® Implantation | One arm: ALLOB® Implantation ALLOB® implantation: Each patient will undergo a single administration of ALLOB® into the delayed-union site under anesthesia. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety population (all patients treated)
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ALLOB® Implantation | One arm: ALLOB® Implantation ALLOB® implantation: Each patient will undergo a single administration of ALLOB® into the delayed-union site under anesthesia. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Responders at 6 Months (Efficacy of ALLOB) | 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). | The efficacy analysis was conducted on the Per Protocol population (21 treated patients; one patient being excluded from the analysis due on a major protocol deviation) | Posted | Number | 90% Confidence Interval | percent of patients | 6 months |
|
6 months
Emergence was defined from the date of ALLOB® implantation up to end of study visit (Month-6 visit)
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ALLOB® Implantation | One arm: ALLOB® Implantation ALLOB® implantation: Each patient will undergo a single administration of ALLOB® into the delayed-union site under anesthesia. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| implant site infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Bone Therapeutics | +32 71 12 10 00 | regulatory@bonetherapeutics.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 2, 2017 | Sep 1, 2021 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D009140 | Musculoskeletal Diseases |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
|
|
|
| 0 |
| 22 |
| 2 |
| 22 |
| 9 |
| 22 |
| angioedema | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
|
| Vitamin D Deficiency | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
|
Not provided
Not provided