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

Launched by BONUSBIO GROUP LTD · Jan 15, 2017

Keywords

ClinConnect Summary

Primary Endpoint:

Safety: to establish that the transplantation of BonoFill-II into bone defect/gap is safe under the following conditions:

* No treatment-related appearance of heterotrophic bone ossification
* No excessive bone formation at the transplantation sites
* No abnormalities in the treated sites

Efficacy: to establish that the transplantation of BonoFill-II into bone defect/gap is effective under the following conditions:

Bone continuity rate, measured radiographically by CT at 6 and 12 months.

Gender

ALL

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 anywhere in the body except in the injured bone site that is in question and needs osteogenic treatment.
• • Subjects with recorded medical history diseases such as heart diseases, renal failure.
• • 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
• • Subjects that have a known scar healing problem (keloid formation).
• • Subjects treated with Bisphosphonate drugs
• • Oncology patients in treatment
• • Subjects who received chemotherapy or radiotherapy treatment in the past
• • 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.