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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|