Study on Autologous Osteoblastic Cells Implantation in Hypotrophic Non-Union Fractures
NCT ID: NCT01756326
Last Updated: 2020-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
5 participants
INTERVENTIONAL
2012-06-30
2019-04-30
Brief Summary
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Non-union fractures are defined as fractures that are at least six to nine months old and in which there have been no signs of healing for the last three months. Various causes have been evoked for impaired healing in hypotrophic (atrophic and oligotrophic) non-unions, including poor fracture stabilization, local infection and failure of the osteoblastic cells to multiply. Currently the treatment of choice for non-unions, particularly atrophic non-unions, is bone autograft (or allograft), combined or not with intramedullary nailing, plating, and external fixation devices (Kanakaris et al., 2007). This procedure produces good results but requires an invasive surgery of several hours under general anesthesia and a few days of hospitalization. Because of this, major complications have been reported in up to 20-30% of patients (Pieske et al., 2009, Zimmerman et al., 2009).
This Phase 2b/3 study aims at demonstrating the safety and efficacy of PREOB®, a proprietary population of autologous osteoblastic cells, in the treatment of hypotrophic non-union fractures of long bones. PREOB® will be compared to Bone Autograft in a non-inferiority design.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PREOB® Implantation
Each patient will undergo a single administration of PREOB® into the non-union site, under local or loco-regional anesthesia.
PREOB® Implantation
Bone Autograft
Each patient will be treated by Bone Autograft according to standard-of-care procedure of the investigating site.
Bone Autograft
Interventions
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PREOB® Implantation
Bone Autograft
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of a non-infected hypotrophic non-union fracture of a long bone of at least 6 months at the time of treatment
* Normal hematology function
Exclusion Criteria
* Presence or previous history, or risk factors for diseases caused by prions
* Renal impairment, hepatic impairment
* Patient with poorly controlled diabetes mellitus, severe arterial diseases and/or neuropathy
* Insufficient fracture stability
* Recent osteosynthesis material or bone graft
* Multifocal fracture/non-unions
18 Years
65 Years
ALL
No
Sponsors
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Bone Therapeutics S.A
INDUSTRY
Responsible Party
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Locations
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Investigating site BE01
Anderlecht, , Belgium
Investigating site BE05
Bruges, , Belgium
Investigating site BE09
Brussels, , Belgium
Investigating site BE02
Charleroi, , Belgium
Investigating site BE04
Genk, , Belgium
Investigating site BE06
Ghent, , Belgium
Investigating site BE07
Hasselt, , Belgium
Investigating site BE08
Mons, , Belgium
Investigating site BE03
Ottignies, , Belgium
Investigating site FR01
Amiens, , France
Investigating site FR04
Bordeaux, , France
Investigating site FR06
Évry, , France
Investigating site FR03
Paris, , France
Investigating site FR02
Rouen, , France
Investigating site NL02
Maastricht, , Netherlands
Investigating site NL01
Rotterdam, , Netherlands
Countries
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Other Identifiers
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PREOB-NU3
Identifier Type: -
Identifier Source: org_study_id
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