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

2017-01-19 06:38:21 | BioPortfolio

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 bone extra-articular comminuted fracture

2. Large bone defect or gap incapable of self-regeneration

Description

Primary Endpoint:

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

Secondary Endpoint:

To establish that the transplantation of BonoFill-II into bone defect/gap is effective under the following conditions:

1. Long bone extraarticular comminuted fracture:

- Enhancement of fracture healing is considerably faster than the common time period known for these clinical conditions in at least two thirds of the treated subjects.

2. Large bone defect or gap incapable of self-regeneration:

- A newly formed bone tissue is generated within the bone gap which re-establishes bone continuity in at least two thirds of the treated subjects.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Bone Fracture

Intervention

BonoFill-II

Location

Emek Medical Center
`Afula
Israel
1834111

Status

Not yet recruiting

Source

BonusBio Group Ltd

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-01-19T06:38:21-0500

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Medical and Biotech [MESH] Definitions

Implantable fracture fixation devices attached to bone fragments with screws to bridge the fracture gap and shield the fracture site from stress as bone heals. (UMDNS, 1999)

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