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

Bonus BioGroup

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Bone Fracture

Treatments: Biological: BonoFill-II

Study type: Interventional

Funder types: Industry

Identifiers

NCT03024008

CP-BNS05

Details and patient eligibility

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

Full description

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, measured radiographically by CT at 6 and 12 months.
• Weight-bearing ability, assessed at 6 and 12 months.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Intervention Arm

Experimental group

Description:

Clinical Interventions: 1. Blood tests: complete blood count, full blood chemistry and biochemistry including phosphate, alkaline phosphatase, calcium, renal and liver function, and coagulation. Serology tests: HIV, Hepatitis B, Hepatitis C. 2. Xray 3. Urine Test 4. CT 5. Liposuction - harvest of 50-300ml autologous adipose tissue from the subject's abdomen 6. Single transplantation of Investigational Medicinal Product BonoFill-II into long bone extra-articular comminuted fracture or large bone defect/critical gap

Treatment:

Biological: BonoFill-II