A Phase 1/2 interventional study of BonoFill-II in Bone Fracture, sponsored by BonusBio Group Ltd. Recruiting at 6 sites in Israel. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-10.
Sponsored by BonusBio Group Ltd · Phase 1/2, Interventional, and Treatment
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:
Primary Endpoint:
Safety: to establish that the transplantation of BonoFill-II into bone defect/gap is safe under the following conditions:
Efficacy: to establish that the transplantation of BonoFill-II into bone defect/gap is effective under the following conditions:
Exclusion Criteria:
Clinical Interventions: 1. 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. 2. Xray 3. Urine Test 4. CT 5. Liposuction - harvest of 50-300ml autologous adipose tissue from the subject's abdomen 6. Single transplantation of Investigational Medicinal Product BonoFill-II into long bone extra-articular comminuted fracture or large bone defect/critical gap
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.
Primary safety endpoint: Absence of treatment-emergent appearance of safety issues
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.
Time frame: Throughout the post-intervention 12-month follow-up
Efficacy endpoint: Bone continuity
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.
Time frame: Starting 4-week follow-up and through to the end of the 12-month follow-up
Functional efficacy endpoint: Weight bearing ability
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).
Time frame: The test is performed at 3, 6 and 12 months post operation.
Lack of pain at the surgical site
Pain at the surgical site will be evaluated using a VAS pain scale, this assessment will be used in cases of bone defect where weight-bearing is not applicable due to further limb injuries (such as nerve injuries or other non-bone defects).
Time frame: 3, 6 and 12 months
Plan to share: No
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