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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- BonusBio Group Ltd
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Safety of Bonofill-ll Administration
Study Overview
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:
- Bone augmentation (e.g. sinus augmentation)
- Bone grafting after removal of cysts from jaws
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject in general good health in the opinion of the investigator as determined by medical history, vital signs physical examination and safety lab tests
- •Subject has a rehabilitation dentist and rehabilitation program
- •Up to date panoramic X-Ray/CT
- •Subject has provided written informed consent to participate in the study, understands all study procedures and agrees to follow up procedures
- •Subject is in good oral hygiene condition as per investigator's discretion
- •SINUS AUGMENTATION
- •The subjects requires sinus augmentation as per investigator's discretion
- •Healthy condition of Maxillary Sinuses and Oral Mucosa determined by X-ray
- •BONE GRAFTING AFTER REMOVAL OF CYSTS FROM JAWS
- •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.
- •Subject's cyst was removed after diagnosis of the cyst type
Exclusion Criteria
- •Subject with a recorded medical history of diseases such as diabetes mellitus, heart diseases, renal failure, osteoporosis, Multiple sclerosis,
- •Subject treated with systemic steroids
- •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.
- •Subject has vitiligo or a known scar healing problems (keloid formation)
- •Subject treated with Oral Bisphosphonate drugs (such as Fosalan and other similar medications)
- •Subjects underwent one of the following treatments up to 12 months prior to Visit 1: Chemotherapy, Radiotherqapy
- •In case of sinus augmentation - unhealthy conditions of Maxillary Sinuses.
- •Subject with current active infection or illness.
- •Subject participating in another clinical trial 30 days prior to and during the study period.
- •Subject is a pregnant or lactating woman. Pregnancy will be verified by urine test during screening.
- •Subject has a known history of any significant medical disorder, which in the investigator's discretion contraindicates the subject's participation.
- •Subject has a known allergy for anesthesia.
- •Subjects with known allergy to hyaluronic acid.
- •Subjects with known allergy to HypoThermosol® or Dextran-
- •Subjects with known allergy to any of the antibiotics: Bacitracin, Gentamicin and/or Polymyxin B Sulfate.
- •Positive serology for either HIV, hepatitis B or hepatitis C.
- •Abnormal clinically significant laboratory test and exams findings as per investigator's discretion.
Arms & Interventions
Intervention Arm
1 Arm - IMP treatment arm
Intervention: BonoFill-II (Biological)
Outcomes
Primary Outcomes
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 chronic bone infection (Osteomyelitis); no significant changes in complete blood count (CBC) and in general health.
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 at the end of the study (residual + Augmented bone at 3 evenly-spaced locations). Successful bone regeneration is achieved if: * Bone formation inside the maxillary sinus or bone void, in the area of dental implantation defined at Visit 1 (prior to BonoFill-ll transplantation), with average height (residual + augmented bone) of at least 8mm, OR * Bone formation inside the maxillary sinus in the area of dental implantation defined at Visit 1 (prior to BonoFill-II transplantation), allowing successful dental implantation.
Secondary Outcomes
No secondary outcomes reported