Enhancement of Bone Regeneration and Healing in the Extremities by the Use of Autologous BonoFill-II

Официальное название

A Multicenter Study to Evaluate the Enhancement of Bone Regeneration and Healing in the Extremities by the Use of Autologous BonoFill-II

Обзор

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: 1. Long and short bone extra-articular comminuted fracture 2. Long and short bones extra and intra articular defect /Gap or non-union, incapable of self-regeneration

Подробное описание

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.

Вмешательства

• Биопрепарат BonoFill-II
  Surgery will be performed under local or general anesthetics according to the Investigator's and anesthesiologist discretion. A standard orthopedic approach will be made according to the fracture site.Then the transplantation of BonoFill-II into the fracture site and the fixation of the fracture by intramedullary nail or plate and screws or external fixator as required will be performed. internal fixation (plate and screws and intramedullary nails) will not be routinely removed. External fixat

Первичные конечные точки

• Primary safety endpoint: Absence of treatment-emergent appearance of safety issues [Срок оценки: Throughout the post-intervention 12-month follow-up]
• Efficacy endpoint: Bone continuity [Срок оценки: Starting 4-week follow-up and through to the end of the 12-month follow-up]
• Functional efficacy endpoint: Weight bearing ability [Срок оценки: The test is performed at 3, 6 and 12 months post operation.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Израиль · 6 центров

• Emek Medical Center — Afula
• Barzilai Medical Center — Ashkelon
• Hillel Yafe — Hadera
• Carmel Medical Center — Haifa
• Rambam Health Campus — Haifa
• Meir Medical Center — Kfar Saba

Идентификаторы

NCT: NCT03024008 · CP-BNS05

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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