Phase 2b/3 Study on Autologous Osteoblastic Cells Implantation in Hypotrophic Non-Union Fractures

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Bone Therapeutics S.A
Sponsor:
Information provided by (Responsible Party):
Bone Therapeutics S.A
ClinicalTrials.gov Identifier:
NCT01756326
First received: December 20, 2012
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Long Bone Non-Union
Drug: PREOB® Implantation
Procedure: Bone Autograft
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bone Therapeutics S.A:

Primary Outcome Measures:
  • Global Disease Evaluation as perceived by the patient using a Visual Analogue Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Radiological healing progression using the RUS(T) as assessed by CT scan [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pain using a Visual Analogue Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Weight-bearing using Likert Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Well-being score as assessed by the SF-12 questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Radiological improvement using the RUS(T) as assessed by X-ray [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 176
Study Start Date: June 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01756326

Contacts
Contact: Enrico Bastianelli, MD, MBA preob.nu3@bonetherapeutics.com

Locations
Belgium
Investigating site BE01 Recruiting
Anderlecht, Belgium
Investigating site BE09 Recruiting
Anderlecht, Belgium
Investigating site BE05 Recruiting
Brugge, Belgium
Principal Investigator: Stefan Desmyter, MD         
Investigating site BE02 Recruiting
Charleroi, Belgium
Investigating site BE04 Recruiting
Genk, Belgium
Investigating site BE06 Recruiting
Gent, Belgium
Investigating site BE07 Recruiting
Hasselt, Belgium
Investigating site BE08 Recruiting
Mons, Belgium
Investigating site BE03 Recruiting
Ottignies, Belgium
France
Investigating site FR01 Not yet recruiting
Amiens, France
Investigating site FR04 Not yet recruiting
Bordeaux, France
Investigating site FR06 Not yet recruiting
Evry, France
Investigating site FR03 Not yet recruiting
Paris, France
Investigating site FR02 Not yet recruiting
Rouen, France
Netherlands
Investigating site NL02 Recruiting
Maastricht, Netherlands
Investigating site NL01 Not yet recruiting
Rotterdam, Netherlands
Sponsors and Collaborators
Bone Therapeutics S.A
  More Information

No publications provided

Responsible Party: Bone Therapeutics S.A
ClinicalTrials.gov Identifier: NCT01756326     History of Changes
Other Study ID Numbers: PREOB-NU3
Study First Received: December 20, 2012
Last Updated: November 22, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Netherlands: Ministry of Health, Welfare and Sport

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

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

ClinicalTrials.gov processed this record on October 02, 2014