Using your own cells with BonoFill-II to help rebuild and heal broken bones in the arms or legs
A Multicenter Study to Evaluate the Enhancement of Bone Regeneration and Healing in the Extremities by the Use of Autologous BonoFill-II
This trial tests whether BonoFill-II, an autologous bone-regenerating graft made from your own cells, can help people with complex limb fractures or non-healing bone gaps heal and regain weight-bearing ability.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | BonusBio Group Ltd Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 6 sites (Afula and 5 other locations) |
| Trial ID | NCT03024008 on ClinicalTrials.gov |
What this trial studies
This Phase 1/2 interventional trial implants an autologous cell-based graft (BonoFill-II) into deficient bone at sites of extra-articular comminuted fractures or extra-/intra-articular defects and non-unions that cannot self-regenerate. Participants will undergo surgical implantation of the graft prepared from their own cells and will be followed with clinical assessments and radiographic CT imaging. Safety endpoints include absence of heterotopic ossification, excessive bone formation, or local abnormalities, and efficacy endpoints include radiographic bone continuity and return of weight-bearing at 6 and 12 months. The trial is conducted at multiple hospital sites in Israel with scheduled follow-up visits for imaging and functional assessment.
Who should consider this trial
Good fit: Adults aged 18–80 with extra-articular comminuted long or short bone fractures or with extra- or intra-articular bone defects/gaps or non-unions that are incapable of self-regeneration are the intended candidates.
Not a fit: Patients with simple fractures treatable by a single definitive procedure, active local infection, uncontrolled diabetes (HbA1c > 8), severe organ failure, certain autoimmune diseases, current systemic steroid therapy, pregnancy/lactation, or more than three prior failed interventions at the site are unlikely to benefit or are ineligible.
Why it matters
Potential benefit: If successful, BonoFill-II could promote bone regeneration in difficult fractures or non-unions and reduce the need for additional surgeries while restoring the ability to bear weight.
How similar studies have performed: Previous clinical work with autologous cell grafts and bone morphogenetic proteins has shown promise for improving bone healing, but BonoFill-II represents a newer, less widely studied cell-based approach with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Afula and 5 other locations
- Emek Medical Center — Afula, Israel (Recruiting)
- Barzilai Medical Center — Ashkelon, Israel (Recruiting)
- Hillel Yafe — Hadera, Israel (Recruiting)
- Carmel Medical Center — Haifa, Israel (Recruiting)
- Rambam Health Campus — Haifa, Israel (Recruiting)
- Meir Medical Center — Kfar Saba, Israel (Recruiting)
Study contacts
- Principal investigator: Nimrod Rozen, MD, PhD — Emek Medical Center, Afula, Israel
- Study coordinator: Nimrod Rozen, MD, PhD
- Email: nimrod_rozen@hotmail.com
- Phone: +972-4-649-4201
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.