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

Long Bone Non-Union Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01756326
• Other study ID #: PREOB-NU3
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: June 2012
• Est. completion date: April 2019

Study information

• Verified date: June 2020
• Source: Bone Therapeutics S.A
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: April 2019
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Ununited
• Long Bone Non-Union

Intervention

Drug:
• PREOB® Implantation

Procedure:
• Bone Autograft

Locations

Country	Name	City	State
Belgium	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
France	Investigating site FR01	Amiens
France	Investigating site FR04	Bordeaux
France	Investigating site FR06	Evry
France	Investigating site FR03	Paris
France	Investigating site FR02	Rouen
Netherlands	Investigating site NL02	Maastricht
Netherlands	Investigating site NL01	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Bone Therapeutics S.A

Countries where clinical trial is conducted

Belgium,  France,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Disease Evaluation as perceived by the patient using a Visual Analogue Scale		12 months
Primary	Radiological healing progression using the RUS(T) as assessed by CT scan		12 months
Primary	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		12 months
Secondary	Pain using a Visual Analogue Scale		12 months
Secondary	Weight-bearing using Likert Scale		12 months
Secondary	Well-being score as assessed by the SF-12 questionnaire		12 months
Secondary	Radiological improvement using the RUS(T) as assessed by X-ray		12 months