Enhancement of Bone Regeneration and Healing in the Extremities by the Use of Autologous BonoFill-II
NCT ID: NCT03024008
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2017-07-27
2027-06-30
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention Arm
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Long and short bones extra and intra articular defect/gap or non union, incapable of self-regeneration
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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BonusBio Group Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Nimrod Rozen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Emek Medical Center, Afula, Israel
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CP-BNS05
Identifier Type: -
Identifier Source: org_study_id
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