Study on Autologous Osteoblastic Cells Implantation in Hypotrophic Non-Union Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01756326
Recruitment Status : Active, not recruiting
First Posted : December 25, 2012
Last Update Posted : July 25, 2018
Information provided by (Responsible Party):
Bone Therapeutics S.A

Brief Summary:

Fracture healing is a complex physiological process caused by interaction of cellular elements, cytokines and signaling proteins, which results in the formation of new bone (Gerstenfeld et al., 2003). Depending on fracture site, complexity, co-morbidities and other factors, 10% of all fractures will eventually fail to unite.

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.

Condition or disease Intervention/treatment Phase
Long Bone Non-Union Drug: PREOB® Implantation Procedure: Bone Autograft Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pivotal Phase 2b/3, Multicentre, Randomised, Open, Controlled Study on the Efficacy and Safety of Autologous Osteoblastic Cells (PREOB®) Implantation in Non-Infected Hypotrophic Non-Union Fractures
Study Start Date : June 2012
Actual Primary Completion Date : April 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Experimental: PREOB® Implantation
Each patient will undergo a single administration of PREOB® into the non-union site, under local or loco-regional anesthesia.
Drug: PREOB® Implantation
Active Comparator: Bone Autograft
Each patient will be treated by Bone Autograft according to standard-of-care procedure of the investigating site.
Procedure: Bone Autograft

Primary Outcome Measures :
  1. Global Disease Evaluation as perceived by the patient using a Visual Analogue Scale [ Time Frame: 12 months ]
  2. Radiological healing progression using the RUS(T) as assessed by CT scan [ Time Frame: 12 months ]
  3. Potential occurrence of any AE or SAE, related to the product or to the procedure, using patient open non-directive questionnaire, physical examination and laboratory measurements [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Pain using a Visual Analogue Scale [ Time Frame: 12 months ]
  2. Weight-bearing using Likert Scale [ Time Frame: 12 months ]
  3. Well-being score as assessed by the SF-12 questionnaire [ Time Frame: 12 months ]
  4. Radiological improvement using the RUS(T) as assessed by X-ray [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ability to provide a written, dated, and signed informed consent prior to any study related procedure, and to understand and comply with study requirements
  • 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:

  • Positive serology for HIV, hepatitis B, hepatitis C, syphilis, HTLV-1
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01756326

Investigating site BE01
Anderlecht, Belgium
Investigating site BE05
Brugge, Belgium
Investigating site BE09
Brussels, Belgium
Investigating site BE02
Charleroi, Belgium
Investigating site BE04
Genk, Belgium
Investigating site BE06
Gent, 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
Evry, France
Investigating site FR03
Paris, France
Investigating site FR02
Rouen, France
Investigating site NL02
Maastricht, Netherlands
Investigating site NL01
Rotterdam, Netherlands
Sponsors and Collaborators
Bone Therapeutics S.A

Responsible Party: Bone Therapeutics S.A Identifier: NCT01756326     History of Changes
Other Study ID Numbers: PREOB-NU3
First Posted: December 25, 2012    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: December 2017

Keywords provided by Bone Therapeutics S.A:
Non-Union Fractures
Impaired Healing
Musculoskeletal Disorders

Additional relevant MeSH terms:
Fractures, Ununited
Fractures, Bone
Wounds and Injuries