Clinical trial NCT03024008: Enhancement of Bone Regeneration and Healing in the Extremities by the Use of Autologous BonoFill-II
Official title: A Multicenter Study to Evaluate the Enhancement of Bone Regeneration and Healing in the Extremities by the Use of Autologous BonoFill-II
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Bone Fracture
Keywords: Critical Gap
Comminuted Fracture
Extra-Articular
Lead sponsor: BonusBio Group Ltd
Sponsor class: INDUSTRY
First posted: 2017-01-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

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.

Primary outcomes:
measure: Number of subjects with treatment-emergent appearance of safety issues
timeFrame: Throughout the post-intervention 12-month follow-up
Secondary outcomes:
measure: Bone continuity
timeFrame: Starting 4-week follow-up and through to the end of the 12-month follow-up
measure: Time to union
timeFrame: Starting 4-week follow-up and through to the end of the 12-month follow-up
measure: Weight bearing ability
timeFrame: 3, 6 and 12 months
measure: Lack of pain at the surgical site
timeFrame: 3, 6 and 12 months
Other outcomes:
Locations:
city: 'Afula
country: Israel
facility: Emek Medical Center
city: Hadera
country: Israel
facility: Hillel Yafe
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Haifa
country: Israel
facility: Rambam Health Campus
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Emek Medical Center, Afula, Israel
name: Nimrod Rozen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: