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PREOB Implantation in Non-Infected Hypotrophic Non-Union Fractures

NCT01756326Phase 3

Key facts

Status: Terminated
Start: Jun 2012
Primary completion: Apr 2018
Countries: 3
Sponsor: BioSenic
Modality: Stem Cell Therapies

Drugs: PREOB
Conditions: non-union fracture

Overview

Phase 3, randomised, open-label trial of PREOB in non-union fracture (2 arms), sponsored by BioSenic. Primary endpoints: Global Disease Evaluation as perceived by the patient at 12 months, Radiological healing progression using the RUS(T) at 12 months and 1 more. Started Jun 2012; status: terminated.

Design

2 arms

Study design: RandomizedOpen-label

PREOB Implantation
Single administration of PREOB into the non-union site
Bone Autograft
Standard-of-care Bone Autograft procedure

Who it enrols

Patients with non-infected hypotrophic non-union fractures of long bones (at least 6 months duration) and normal hematology function. Excludes patients with HIV, Hepatitis B/C, Syphilis, HTLV-1, renal or hepatic impairment, poorly controlled diabetes, severe arterial diseases, neuropathy, insufficient fracture stability, recent osteosynthesis/bone graft, or multifocal fractures.

Endpoints

Primary

Global Disease Evaluation as perceived by the patient12 months
Radiological healing progression using the RUS(T)12 months
Potential occurrence of any AE or SAE12 months

Secondary

Pain using a Visual Analogue Scale12 months
Weight-bearing using Likert Scale12 months
Well-being score as assessed by the SF-12 questionnaire12 months
Radiological improvement using the RUS(T)12 months

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