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

NCT03024008 | Recruiting Phase 1

• 1 other identifier: CP-BNS05
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 6

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. 1.Long and short bone extra-articular comminuted fracture
2. 2.Long and short bones extra and intra articular defect /Gap or non-union, incapable of self-regeneration

Conditions

Bone Fracture

Keywords

Critical Gap; Comminuted Fracture; Extra-Articular

Outcome Measures

Primary Outcomes (3)

• Primary safety endpoint: Absence of treatment-emergent appearance of safety issues

  Subjects demonstrating no appearance of heterotrophic bone ossification, excessive bone formation and/or any abnormalities in the treated site, in the proximal or distal joint by visual examination of the transplantation site and by X-ray and/or CT.

  Throughout the post-intervention 12-month follow-up

• Efficacy endpoint: Bone continuity

  Bone union, as assessed by X-ray and CT. CT scans are performed 6 and 12 months post operation, to verify bone regeneration and complete bone continuity was achieved.

  Starting 4-week follow-up and through to the end of the 12-month follow-up

• Functional efficacy endpoint: Weight bearing ability

  clinical examination of weight bearing ability for lower extremities or coffee-cup weight bearing ability for upper extremities. The physician assesses the functionality of the operated limb, by testing the patients ability to bear their weight when standing (in case of lower limb bone defect) or by coffee cup holding simulation (in case of upper limb bone defect).

  The test is performed at 3, 6 and 12 months post operation.

Other Outcomes (1)

• Lack of pain at the surgical site

  3, 6 and 12 months

Study Arms (1)

Intervention Arm

EXPERIMENTAL

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

Biological: BonoFill-II

Interventions

BonoFill-II BIOLOGICAL

Surgery will be performed under local or general anesthetics according to the Investigator's and anesthesiologist discretion. A standard orthopedic approach will be made according to the fracture site.Then the transplantation of BonoFill-II into the fracture site and the fixation of the fracture by intramedullary nail or plate and screws or external fixator as required will be performed. internal fixation (plate and screws and intramedullary nails) will not be routinely removed. External fixators will be removed upon achievement of satisfactory bone union.

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• BonusBio Group Ltd: lead

Study Sites (6)

Emek Medical Center

Afula, 1834111, Israel

RECRUITING

Barzilai Medical Center

Ashkelon, 7830604, Israel

RECRUITING

Hillel Yafe

Hadera, Israel

RECRUITING

Carmel Medical Center

Haifa, Israel

RECRUITING

Rambam Health Campus

Haifa, Israel

RECRUITING

Meir Medical Center

Kfar Saba, Israel

RECRUITING

MeSH Terms

Conditions

Fractures, Bone; Fractures, Comminuted

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Nimrod Rozen, MD, PhD

  Emek Medical Center, Afula, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nimrod Rozen, MD, PhD

CONTACT

+972-4-649-4201; nimrod_rozen@hotmail.com

Vered Kivity, PhD, MBA

CONTACT

+972-73-206-7103; veredki@bonus-bio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 18, 2017
• Study Start: July 27, 2017
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (6)