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The purpose of this clinical study is to evaluate the safety and the efficacy of BonoFill-II as a bone filler containing the patient's own (autologous) adipose (fat) tissue-derived cells in reconstructing bone in two clinical indications:
Safety endpoint:
The transplantation of BonoFill-II to the maxillary or mandible defect/void is safe under the following conditions: No chronic bone infection (Osteomyelitis); no significant changes in complete blood count (CBC) and in general health.
Efficacy endpoint:
The transplantation of BonoFill-II to the maxillary or mandible void is efficient: the bone defects/voids are filled with at least 8mm of total bone height at the transplanted area.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | 1 Arm - IMP treatment arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BonoFill-II | Biological | Sinus augmentation - Surgery will be performed by either open or close sinus augmentation as per investigator discretion and as per common medical practice. After the elevation, BonoFill-II will be transplanted on the residual sub-antral bone. Bone grafting after removal of cysts from jaws - Treatment will be performed according to the size of the cyst: in relatively small cyst total enucleation will be performed. In large cysts, a process of marsupialization will be performed. The entire cyst will be removed, including the epithelium layer, and the BonoFill-II product will be used for filling. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Bonofill-ll Administration | The study will assess the safety of the BonoFill-II drug product post transplantation by demonstrating No chronic bone infection (Osteomyelitis); no significant changes in complete blood count (CBC) and in general health. | 6-month clinical Follow Up |
| Efficacy of Bonofill-ll Administration | Following BonoFill-II transplantation, the bone regeneration in the operated site will be evaluated using CT or panoramic X Ray. Bone formation at the implantation site inside the maxillary sinus will be evaluated by measuring the bone height at the end of the study (residual + Augmented bone at 3 evenly-spaced locations). Successful bone regeneration is achieved if:
| 6-month clinical Follow Up |
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Inclusion Criteria:
GENERAL
SINUS AUGMENTATION
BONE GRAFTING AFTER REMOVAL OF CYSTS FROM JAWS
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vered Kivity, PhD, MBA | Bonus BioGroup | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oral and Maxillofacial Surgery Clinic - Beit Merik | Kfar Saba | Israel |
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