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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Safety of Bonofill-ll Administration
研究概览
简要总结
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
详细描述
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.
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Intervention Arm
1 Arm - IMP treatment arm
干预措施: BonoFill-II (Biological)
结局指标
主要结局
Safety of Bonofill-ll Administration
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点