Filling Bone Defects/Voids With Autologous BonoFill-II for Maxillofacial Bone Regeneration

NCT02842619 | Completed Phase 1

• 1 other identifier: CP-BNS03
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical study is to evaluate the safety and the efficacy of BonoFill-II as a bone filler containing the patient's own (autologous) adipose (fat) tissue-derived cells in reconstructing bone in two clinical indications:

1. 1.Bone augmentation (e.g. sinus augmentation)
2. 2.Bone grafting after removal of cysts from jaws

Conditions

Bone Augmentation; Bone Grafts

Outcome Measures

Primary Outcomes (2)

• Safety of Bonofill-ll Administration

  The study will assess the safety of the BonoFill-II drug product post transplantation by demonstrating No chronic bone infection (Osteomyelitis); no significant changes in complete blood count (CBC) and in general health.

  6-month clinical Follow Up

• Efficacy of Bonofill-ll Administration

  Following BonoFill-II transplantation, the bone regeneration in the operated site will be evaluated using CT or panoramic X Ray. Bone formation at the implantation site inside the maxillary sinus will be evaluated by measuring the bone height at the end of the study (residual + Augmented bone at 3 evenly-spaced locations). Successful bone regeneration is achieved if: * Bone formation inside the maxillary sinus or bone void, in the area of dental implantation defined at Visit 1 (prior to BonoFill-ll transplantation), with average height (residual + augmented bone) of at least 8mm, OR * Bone formation inside the maxillary sinus in the area of dental implantation defined at Visit 1 (prior to BonoFill-II transplantation), allowing successful dental implantation.

  6-month clinical Follow Up

Study Arms (1)

Intervention Arm

EXPERIMENTAL

1 Arm - IMP treatment arm

Biological: BonoFill-II

Interventions

BonoFill-II BIOLOGICAL

Sinus augmentation - Surgery will be performed by either open or close sinus augmentation as per investigator discretion and as per common medical practice. After the elevation, BonoFill-II will be transplanted on the residual sub-antral bone. Bone grafting after removal of cysts from jaws - Treatment will be performed according to the size of the cyst: in relatively small cyst total enucleation will be performed. In large cysts, a process of marsupialization will be performed. The entire cyst will be removed, including the epithelium layer, and the BonoFill-II product will be used for filling.

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:

• GENERAL
• Subject in general good health in the opinion of the investigator as determined by medical history, vital signs physical examination and safety lab tests
• Subject has a rehabilitation dentist and rehabilitation program
• Up to date panoramic X-Ray/CT
• Subject has provided written informed consent to participate in the study, understands all study procedures and agrees to follow up procedures
• Subject is in good oral hygiene condition as per investigator's discretion
• SINUS AUGMENTATION
• The subjects requires sinus augmentation as per investigator's discretion
• Healthy condition of Maxillary Sinuses and Oral Mucosa determined by X-ray
• BONE GRAFTING AFTER REMOVAL OF CYSTS FROM JAWS
• Subject who according to investigator diagnosis required removal of cysts from jaws. Limited to cysts diagnosed as: radicular cysts, residual cysts, congenital cysts, developmental and acquired cysts.
• Subject's cyst was removed after diagnosis of the cyst type

You may not qualify if:

• Subject with a recorded medical history of diseases such as diabetes mellitus, heart diseases, renal failure, osteoporosis, Multiple sclerosis,
• Subject treated with systemic steroids
• Subject with a known autoimmune disease, such as Addison's disease, Myasthenia gravis, Pernicious anemia, Reactive arthritis, Rheumatoid arthritis, Sjogren syndrome, Systemic lupus erythematosus, Type I diabetes.
• Subject has vitiligo or a known scar healing problems (keloid formation)
• Subject treated with Oral Bisphosphonate drugs (such as Fosalan and other similar medications)
• Subjects underwent one of the following treatments up to 12 months prior to Visit 1: Chemotherapy, Radiotherqapy
• In case of sinus augmentation - unhealthy conditions of Maxillary Sinuses.
• Subject with current active infection or illness.
• Subject participating in another clinical trial 30 days prior to and during the study period.
• Subject is a pregnant or lactating woman. Pregnancy will be verified by urine test during screening.
• Subject has a known history of any significant medical disorder, which in the investigator's discretion contraindicates the subject's participation.
• Subject has a known allergy for anesthesia.
• Subjects with known allergy to hyaluronic acid.
• Subjects with known allergy to HypoThermosol® or Dextran-40.
• Subjects with known allergy to any of the antibiotics: Bacitracin, Gentamicin and/or Polymyxin B Sulfate.

Sponsors & Collaborators

• BonusBio Group Ltd: lead

Study Sites (1)

Oral and Maxillofacial Surgery Clinic - Beit Merik

Kfar Saba, Israel

Location

Study Officials

• Vered Kivity, PhD, MBA

  Bonus BioGroup

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: July 25, 2016
• Study Start: July 23, 2016
• Primary Completion: June 2, 2024
• Study Completion: November 30, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)