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Phase I/II Open Label Single Center Clinical Study Aimed to Evaluate the Safety and Efficacy of BonoFill-II in Reconstructing Bone in the Extremities (NCT03024008)

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 bone extra-articular comminuted fracture 2. Large bone defect or gap incapable of self-regeneration
  • Biological: 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 fixators will be removed upon achievement of satisfactory bone union.
    Ages eligible for Study
    18 Years to 75 Years
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    Inclusion Criteria:
    • Long bone extra-articular comminuted fracture:
    • Subject with fracture requiring temporary fixation (to be carried out prior to enrollment in the study) followed by definitive treatment (to be carried out in the framework of the study). This could be the outcome of various reasons, such as an open fracture, and/or a multisystem injury where definitive treatment could not have been performed upon admission.
    • Large bone defect or gap incapable of self-regeneration
    • Subject who suffer from a large bone defect or gap incapable of self-regeneration
    Exclusion Criteria:
    • Intra-articular fractures
    • Age is under 18 or above 75
    • A simple fracture manageable by one definitive treatment
    • Pregnant or lactating women
    • Patients with active infection anywhere in the body except in the injured bone site that is in question and needs osteogenic treatment.
    • Subjects with recorded medical history diseases such as heart diseases, renal failure.
    • 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
    • Subjects that have a known scar healing problem (keloid formation).
    • Subjects treated with Bisphosphonate drugs
    • Oncology patients in treatment
    • Subjects who received chemotherapy or radiotherapy treatment in the past
    • Subjects participating in another clinical trial 30 days prior to and during the study period.
    • 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.
    Primary Endpoint:

    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

    Secondary Endpoint:

    To establish that the transplantation of BonoFill-II into bone defect/gap is effective under the following conditions:

    1. Long bone extraarticular comminuted fracture:

    - Enhancement of fracture healing is considerably faster than the common time period known for these clinical conditions in at least two thirds of the treated subjects.

    2. Large bone defect or gap incapable of self-regeneration:

    - A newly formed bone tissue is generated within the bone gap which re-establishes bone continuity in at least two thirds of the treated subjects.

    1 locations

    Israel (1)
    • Emek Medical Center
      not yet recruiting
      `Afula, Israel, 1834111
    Status:
    not yet recruiting
    Type:
    Interventional
    Phase:
    Ⅰ, Ⅱ
    Start:
    31 December, 2016
    Updated:
    14 January, 2017
    Participants:
    10
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