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

NCT02842619 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-12-10

No results posted yet for this study

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

Conditions

  • Bone Augmentation
  • Bone Grafts

Interventions

BIOLOGICAL

BonoFill-II

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.

Sponsors & Collaborators

  • BonusBio Group Ltd

    lead INDUSTRY

Principal Investigators

  • Vered Kivity, PhD, MBA · Bonus BioGroup

Study Design

Allocation
NA
Purpose
TREATMENT
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-23
Primary Completion
2024-06-02
Completion
2025-11-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02842619 on ClinicalTrials.gov