Filling Bone Defects/Voids With Autologous BonoFill-II for Maxillofacial Bone Regeneration
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|ClinicalTrials.gov Identifier: NCT02842619|
Recruitment Status : Recruiting
First Posted : July 25, 2016
Last Update Posted : July 23, 2019
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:
- Bone augmentation (e.g. sinus augmentation)
- Bone grafting after removal of cysts from jaws
|Condition or disease||Intervention/treatment||Phase|
|Bone Augmentation Bone Grafts||Biological: BonoFill-II||Phase 1 Phase 2|
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.
The transplantation of BonoFill-II to the maxillary or mandible void is efficient under the following conditions: Following BonoFill-II implantation, the bone regeneration in the operated site was significantly accelerated. Also, the bone defects/voids were filled with a significant amount of bone tissue.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Open Label First in Human Single Center Clinical Study Aimed to Evaluate the Safety and Efficacy of BonoFill-II in Reconstructing Maxillofacial Bone|
|Actual Study Start Date :||July 23, 2016|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||December 30, 2020|
Experimental: Intervention Arm
1 Arm - IMP treatment arm
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.
- Safety of Bonofill-ll Administration [ Time Frame: 6-month clinical Follow Up ]The study will assess the safety of the BonoFill-II drug product post transplantation by demonstrating no treatment-related adverse events such as chronic bone infection (Osteomyelitis) or significant changes in complete blood counts. adverse events will be assessed by type, severity, seriousness, relatedness, incidence, and duration.
- Efficacy of Bonofill-ll Administration [ Time Frame: 6-month clinical Follow Up ]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 (mm) at the end of the study (residual + Augmented bone at 3 evenly-spaced locations) and comparing to measurements of bone height of the residual bone only prior to Bonofill-ll administration. Efficacy will be evaluated also by having a stable dental implants at the uncovering procedure by the end of the study.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842619
|Contact: Ephraim Tzur, DMDemail@example.com|
|Oral and Maxillofacial Surgery Clinic - Beit Merik||Recruiting|
|Kfar Saba, Israel|
|Contact: Sahar Tzur 972-50-7891113 firstname.lastname@example.org|
|Sub-Investigator: Alex Levenberg, MD|
|Sub-Investigator: Shlomo Bulvik, MD|
|Study Director:||Nir Shtayer, DVM||Bonus BioGroup|