Filling Bone Defects/Voids With Autologous BonoFill-II for Maxillofacial Bone Regeneration
Study Details
Study Description
Brief Summary
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:
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Bone augmentation (e.g. sinus augmentation)
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Bone grafting after removal of cysts from jaws
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
Primary 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.
Secondary endpoint:
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention Arm 1 Arm - IMP treatment arm |
Biological: BonoFill-II
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.
|
Outcome Measures
Primary Outcome Measures
- Safety of Bonofill-ll Administration [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 [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
GENERAL
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Subject in general good health in the opinion of the investigator as determined by medical history, vital signs physical examination and safety lab tests
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Subject has a rehabilitation dentist and rehabilitation program
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Up to date panoramic X-Ray/CT
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Subject has provided written informed consent to participate in the study, understands all study procedures and agrees to follow up procedures
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Subject is in good oral hygiene condition as per investigator's discretion
SINUS AUGMENTATION
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The subjects requires sinus augmentation as per investigator's discretion
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Healthy condition of Maxillary Sinuses and Oral Mucosa determined by X-ray
BONE GRAFTING AFTER REMOVAL OF CYSTS FROM JAWS
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Subject who according to investigator diagnosis required removal of cysts from jaws. Limited to cysts diagnosed as: radicular cysts, residual cysts, congenital cysts, developmental and acquired cysts.
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Subject's cyst was removed after diagnosis of the cyst type
Exclusion Criteria:
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Subject with a recorded medical history of diseases such as diabetes mellitus, heart diseases, renal failure, osteoporosis, Multiple sclerosis,
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Subject treated with systemic steroids
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Subject with a known autoimmune disease, such as Addison's disease, Myasthenia gravis, Pernicious anemia, Reactive arthritis, Rheumatoid arthritis, Sjogren syndrome, Systemic lupus erythematosus, Type I diabetes.
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Subject has vitiligo or a known scar healing problems (keloid formation)
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Subject treated with Oral Bisphosphonate drugs (such as Fosalan and other similar medications)
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Subjects underwent one of the following treatments up to 12 months prior to Visit 1: Chemotherapy, Radiotherqapy
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In case of sinus augmentation - unhealthy conditions of Maxillary Sinuses.
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Subject with current active infection or illness.
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Subject participating in another clinical trial 30 days prior to and during the study period.
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Subject is a pregnant or lactating woman. Pregnancy will be verified by urine test during screening.
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Subject has a known history of any significant medical disorder, which in the investigator's discretion contraindicates the subject's participation.
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Subject has a known allergy for anesthesia.
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Subjects with known allergy to hyaluronic acid.
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Subjects with known allergy to HypoThermosol® or Dextran-40.
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Subjects with known allergy to any of the antibiotics: Bacitracin, Gentamicin and/or Polymyxin B Sulfate.
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Positive serology for either HIV, hepatitis B or hepatitis C.
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Abnormal clinically significant laboratory test and exams findings as per investigator's discretion.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Oral and Maxillofacial Surgery Clinic - Beit Merik | Kfar Saba | Israel |
Sponsors and Collaborators
- BonusBio Group Ltd
Investigators
- Study Director: Vered Kivity, PhD, MBA, Bonus BioGroup
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CP-BNS03