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

Recruiting now · Phase 1/Phase 2

Conditions studied: Bone Fracture

In brief

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

Key facts

Study ID

NCT03024008

Run by

BonusBio Group Ltd

People needed

40

Starts

2017-07-27

Expected to finish

2027-06-01

Last updated by the study team

2025-12-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Emek Medical Center — Afula, Israel (enrolling)
• Barzilai Medical Center — Ashkelon, Israel (enrolling)
• Hillel Yafe — Hadera, Israel (enrolling)
• Carmel Medical Center — Haifa, Israel (enrolling)
• Rambam Health Campus — Haifa, Israel (enrolling)
• Meir Medical Center — Kfar Saba, Israel (enrolling)

Full record on ClinicalTrials.gov

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