NCT03024008 Enhancement of Bone Regeneration and Healing in the Extremities by the Use of Autologous BonoFill-II
| NCT ID | NCT03024008 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | BonusBio Group Ltd |
| Condition | Bone Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2017-07-27 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2017-07-27 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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
Contact & Investigator
Nimrod Rozen, MD, PhD
PRINCIPAL INVESTIGATOR
Emek Medical Center, Afula, Israel
Frequently Asked Questions
Who can join the NCT03024008 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Bone Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03024008 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03024008 currently recruiting?
Yes, NCT03024008 is actively recruiting participants. Contact the research team at nimrod_rozen@hotmail.com for enrollment information.
Where is the NCT03024008 trial being conducted?
This trial is being conducted at Afula, Israel, Ashkelon, Israel, Hadera, Israel, Haifa, Israel and 2 additional locations.
Who is sponsoring the NCT03024008 clinical trial?
NCT03024008 is sponsored by BonusBio Group Ltd. The principal investigator is Nimrod Rozen, MD, PhD at Emek Medical Center, Afula, Israel. The trial plans to enroll 40 participants.