Bone Void in the Maxillofacial Area Clinical Trial
Official title:
Phase I/II Open Label FIH Single Center Clinical Study Aimed to Evaluate the Safety and the Efficacy of BonoFill in Reconstructing the Bone.
| Verified date | January 2017 |
| Source | BonusBio Group Ltd |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Interventional |
Phase I/II open label first in human single center clinical study, is to evaluate the safety
and the efficacy of BonoFill as bone filler containing the patient own (autologous) adipose
tissue derived cells (HATDCs) in reconstructing the Bone Void in the maxillofacial area
approximately 6 month follow up after implantation in the following two clinical
indications:
1. Bone augmentation (e.g. sinus augmentation)
2. Bone grafting after removal of cysts from jaws
| Status | Completed |
| Enrollment | 11 |
| Est. completion date | December 2016 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: The inclusion criteria defining the eligible subjects are divided to two groups according clinical indications: Sinus augmentation - Subjects in general good health in the opinion of the investigator as determined by medical history, vital signs physical examination and safety lab tests - Subjects that have a rehabilitation dentist and rehabilitation program - Up to dated panoramic X-Ray. - Subjects who provided written informed consent to participate in the study, able to understand study procedure and agree for follow up procedures - Healthy conditions of Maxillary Sinuses and Oral Mucosa. - Sub-antral bone at least 4 mm as measured on CBCT/CT. - Have a good oral hygiene condition as per investigator discretion. Bone grafting after removal of cysts from jaws - Healthy subject. - Subjects that have a rehabilitation dental treatment. - Limited to cysts diagnosed as: radicular cysts, residual cysts, congenital cysts, developmental and acquired cysts. - Subjects referred to oral & maxillofacial Dpt for removal of cysts after diagnosis of the cyst type. - Healthy bone determined by X-ray. - Have a good oral hygiene condition. - Subject that does not participate in other clinical study. - Subject able to read and understand and sign the informed consent Exclusion Criteria: - Subjects with recorded medical history diseases as: diabetes mellitus, heart diseases, renal failure, osteoporosis. - Subject treated with systemic steroid treatment - Subjects with known autoimmune diseases, such as: Addison's disease Celiac disease - sprue (gluten-sensitive enteropathy), Dermatomyositis Graves disease, Hashimoto's thyroiditis, Multiple sclerosis, Myasthenia gravis Pernicious anemia, Reactive arthritis, Rheumatoid arthritis, Sjogren syndrome Systemic lupus erythematosus, Type I diabetes. - Subjects that have Vitiligo and/or known scar healing problems (keloid formation). - Subjects treated with anticoagulation medication (such as Coumadin, Plavix and other similar medications) - Subjects treated with Oral Bisphosphonate drugs (such as Fosalan and other similar medications) - Subjects with a history of Chemotherapy or Radiotherapy treatment - In case of sinus augmentation - Unhealthy conditions of Maxillary Sinuses. - Subjects with current active infection or illness - Subjects participating in another clinical trial 30 days prior to and during the study period - Pregnant or lactating woman. Pregnancy will be verified by urine test during screening - Known history of any significant medical disorder, which in the investigator's judgment contraindicates the subject's participation - Subjects with any known allergy for anesthesia - Positive serology for either HIV, hepatitis B or hepatitis C - Abnormal clinically significant as per investigator's judgment laboratory test and exams findings |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Dr. Ephraim Zur Dental Clinic | Kfar Saba |
| Lead Sponsor | Collaborator |
|---|---|
| BonusBio Group Ltd |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | BonoFill is safe | The implantation of BonoFill 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. | approximately 6 month follow up after implantation | Yes |
| Secondary | BonoFill is efficient | The implantation of BonoFill to the maxillary or mandible void is efficient under the following conditions: Following BonoFill 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. | approximately 6 month follow up after implantation | No |