Actively Recruiting
Enhancement of Bone Regeneration and Healing in the Extremities by the Use of Autologous BonoFill-II
Led by BonusBio Group Ltd · Updated on 2025-12-10
40
Participants Needed
6
Research Sites
513 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Enhancement of Bone Regeneration and Healing in the Extremities by the Use of Autologous BonoFill-II
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Age under 18 or above 80 years
- Simple fracture manageable by one definitive treatment
- Pregnant or lactating women
- Patients with active infection needing osteogenic treatment
- More than 3 previous failed interventions at the surgical site
- History of advanced congestive heart failure or acute myocardial infarction
- Renal failure with estimated GFR <30 ml/min/1.73 m2 at screening
- Hepatic insufficiency classified as Child-Pugh B or C
- Diabetic subjects with HbA1c > 8
- Current treatment with systemic steroids
- Known autoimmune diseases such as Addison's disease, Celiac disease, Dermatomyositis, Graves disease, Hashimoto's thyroiditis, Multiple sclerosis, Myasthenia gravis, Pernicious anemia, Reactive arthritis, Rheumatoid arthritis, Sjogren syndrome, Systemic lupus erythematosus
- Diagnosed osteoporosis
- Chronic severe Peripheral Vascular Disease
- Post major vascular operation in the treated limb and above the surgical site
- Known scar healing problems like keloid formation
- Treatment with Bisphosphonate drugs
- Oncology patients or those who received chemotherapy or radiotherapy in the past 12 months
- Immunocompromised condition at screening
- Participation in another clinical trial 30 days prior to and during the study
- Drug addiction or psychiatric patients incapable of giving consent
- Significant medical disorders contraindicating participation
- Known allergy to local or general anesthesia
- Positive serology for HIV, hepatitis B, or hepatitis C
- Abnormal clinically significant laboratory tests as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Emek Medical Center
Afula, Israel, 1834111
Actively Recruiting
2
Barzilai Medical Center
Ashkelon, Israel, 7830604
Actively Recruiting
3
Hillel Yafe
Hadera, Israel
Actively Recruiting
4
Carmel Medical Center
Haifa, Israel
Actively Recruiting
5
Rambam Health Campus
Haifa, Israel
Actively Recruiting
6
Meir Medical Center
Kfar Saba, Israel
Actively Recruiting
Research Team
N
Nimrod Rozen, MD, PhD
CONTACT
V
Vered Kivity, PhD, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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