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โ† Trials
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Enhancement of Bone Regeneration and Healing in the Extremities by the Use of Autologous BonoFill-II

RecruitingPhase 1, Phase 2Ages 18 Years - 80 YearsAllBonusBio Group Ltd
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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What it tests

  • BonoFill-II
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Where

6 sites
Emek Medical Center
Afula, Israel
Barzilai Medical Center
Ashkelon, Israel
Hillel Yafe
Hadera, Israel
Carmel Medical Center
Haifa, Israel
Rambam Health Campus
Haifa, Israel
Meir Medical Center
Kfar Saba, Israel
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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