Phase I/II Open Label FIH Single Center Clinical Study Aimed to Evaluate the Safety and the Efficacy of BonoFill in Reconstructing the Bone.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- BonoFill is safe
研究概览
简要总结
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:
- Bone augmentation (e.g. sinus augmentation)
- Bone grafting after removal of cysts from jaws
详细描述
Primary endpoint: 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.
Secondary endpoint: 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
BonoFill is safe
时间窗: approximately 6 month follow up after implantation
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.
次要结局
- BonoFill is efficient(approximately 6 month follow up after implantation)