NCT03024008

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

A Multicenter Study to Evaluate the Enhancement of Bone Regeneration and Healing in the Extremities by the Use of Autologous BonoFill-II

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• 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 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, measured radiographically by CT at 6 and 12 months. * Weight-bearing ability, assessed at 6 and 12 months.

Conditions

• Bone Fracture

Interventions

Type	Name	Description
BIOLOGICAL	BonoFill-II	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.

Timeline

• Start date: 2017-07-27
• Primary completion: 2027-03-01
• Completion: 2027-06-01
• First posted: 2017-01-18
• Last updated: 2025-12-10

Locations

6 sites across 1 country: Israel