NCT02842619

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

Phase I/II Open Label First in Human Single Center Clinical Study Aimed to Evaluate the Safety and Efficacy of BonoFill-II in Reconstructing Maxillofacial Bone

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: BonusBio Group Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed description

Safety endpoint: The transplantation of BonoFill-II to the maxillary or mandible defect/void is safe under the following conditions: No chronic bone infection (Osteomyelitis); no significant changes in complete blood count (CBC) and in general health. Efficacy endpoint: The transplantation of BonoFill-II to the maxillary or mandible void is efficient: the bone defects/voids are filled with at least 8mm of total bone height at the transplanted area.

Conditions

• Bone Augmentation
• Bone Grafts

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-07-23
• Primary completion: 2024-06-02
• Completion: 2025-11-30
• First posted: 2016-07-25
• Last updated: 2025-12-10

Locations

1 site across 1 country: Israel