Using your own cells with BonoFill-II to help rebuild and heal broken bones in the arms or legs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.