A Multicenter Study to Evaluate the Enhancement of Bone Regeneration and Healing in the Extremities by the Use of Autologous BonoFill-II
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Primary safety endpoint: Absence of treatment-emergent appearance of safety issues
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 an autologous bone-regenerating graft in the reconstruction of deficient bone in two clinical indications:
- Long and short bone extra-articular comminuted fracture
- Long and short bones extra and intra articular defect /Gap or non-union, incapable of self-regeneration
详细描述
Primary Endpoint:
Safety: to establish that the transplantation of BonoFill-II into bone defect/gap is safe under the following conditions:
- No treatment-related appearance of heterotrophic bone ossification
- No excessive bone formation at the transplantation sites
- No abnormalities in the treated sites
Efficacy: to establish that the transplantation of BonoFill-II into bone defect/gap is effective under the following conditions:
- Bone continuity, measured radiographically by CT at 6 and 12 months.
- Weight-bearing ability, assessed at 6 and 12 months.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Long and short bones extra articular comminuted fracture or
- •Long and short bones extra and intra articular defect/gap or non union, incapable of self-regeneration
排除标准
- •Age is under 18 or above 80
- •A simple fracture manageable by one definitive treatment
- •Pregnant or lactating women
- •Patients with active infection that is in question and needs osteogenic treatment.
- •More than 3 previous failed interventions at the surgical site
- •History of advanced congestive heart failure or active acute myocardial infarction (AMI), renal failure (estimated GFR of <30 ml/min/1.73 m2 at screening), or hepatic disease (hepatic insufficiency classified as Child-Pugh B or C)
- •Diabetic subjects (HbA1c > 8)
- •Subject treated currently with systemic steroids.
- •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.
- •Subjects diagnosed with osteoporosis
- •Chronic severe PVD (Peripheral Vascular Disease) subjects
- •Post major vascular operation in the treated limb/s and above the surgical site (with or without Gore-Tex grafting)
- •Subjects that have a known scar healing problem (keloid formation).
- •Subjects treated with Bisphosphonate drugs
- •Oncology patient or subjects who received chemotherapy or radiotherapy treatment in the past 12 months
- •Immunocompromised condition from any reason, at screening
- •Subjects participating in another clinical trial 30 days prior to and during the study period.
- •Drug addicts and psychiatric patients patients incapable of giving consent.
- •Subjects with a known history of any significant medical disorder, which in the investigator's judgment contraindicates the subject's participation
- •Subjects with any known allergy for local/general anesthesia
- •Positive serology for either HIV, hepatitis B or hepatitis C
- •Abnormal clinically significant laboratory test and findings, as per the investigator's judgment
研究组 & 干预措施
Intervention Arm
Clinical Interventions:
- Blood tests: complete blood count, full blood chemistry and biochemistry including phosphate, alkaline phosphatase, calcium, renal and liver function, and coagulation. Serology tests: HIV, Hepatitis B, Hepatitis C.
- Xray
- Urine Test
- CT
- Liposuction - harvest of 50-300ml autologous adipose tissue from the subject's abdomen
- Single transplantation of Investigational Medicinal Product BonoFill-II into long bone extra-articular comminuted fracture or large bone defect/critical gap
干预措施: BonoFill-II (Biological)
结局指标
主要结局
Primary safety endpoint: Absence of treatment-emergent appearance of safety issues
时间窗: Throughout the post-intervention 12-month follow-up
Subjects demonstrating no appearance of heterotrophic bone ossification, excessive bone formation and/or any abnormalities in the treated site, in the proximal or distal joint by visual examination of the transplantation site and by X-ray and/or CT.
Efficacy endpoint: Bone continuity
时间窗: Starting 4-week follow-up and through to the end of the 12-month follow-up
Bone union, as assessed by X-ray and CT. CT scans are performed 6 and 12 months post operation, to verify bone regeneration and complete bone continuity was achieved.
Functional efficacy endpoint: Weight bearing ability
时间窗: The test is performed at 3, 6 and 12 months post operation.
clinical examination of weight bearing ability for lower extremities or coffee-cup weight bearing ability for upper extremities. The physician assesses the functionality of the operated limb, by testing the patients ability to bear their weight when standing (in case of lower limb bone defect) or by coffee cup holding simulation (in case of upper limb bone defect).
次要结局
未报告次要终点