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

NCT01756326 | Terminated Phase 2 DMC

• 1 other identifier: PREOB-NU3
• Study Type: interventional
• Target: 5
• Locations: 3 countries
• Sites: 16

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.

Conditions

Long Bone Non-Union

Keywords

Non-Union Fractures; Impaired Healing; Fractures; Orthopedics; Bone; Musculoskeletal Disorders

Outcome Measures

Primary Outcomes (3)

• Global Disease Evaluation as perceived by the patient using a Visual Analogue Scale

  12 months

• Radiological healing progression using the RUS(T) as assessed by CT scan

  12 months

• 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 Outcomes (4)

• Pain using a Visual Analogue Scale

  12 months

• Weight-bearing using Likert Scale

  12 months

• Well-being score as assessed by the SF-12 questionnaire

  12 months

• Radiological improvement using the RUS(T) as assessed by X-ray

  12 months

Study Arms (2)

PREOB® Implantation

EXPERIMENTAL

Each patient will undergo a single administration of PREOB® into the non-union site, under local or loco-regional anesthesia.

Drug: PREOB® Implantation

Bone Autograft

ACTIVE COMPARATOR

Each patient will be treated by Bone Autograft according to standard-of-care procedure of the investigating site.

Procedure: Bone Autograft

Interventions

PREOB® Implantation DRUG

PREOB® Implantation

Bone Autograft PROCEDURE

Bone Autograft

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bone Therapeutics S.A: lead

Study Sites (16)

Investigating site BE01

Anderlecht, Belgium

Location

Investigating site BE05

Bruges, Belgium

Location

Investigating site BE09

Brussels, Belgium

Location

Investigating site BE02

Charleroi, Belgium

Location

Investigating site BE04

Genk, Belgium

Location

Investigating site BE06

Ghent, Belgium

Location

Investigating site BE07

Hasselt, Belgium

Location

Investigating site BE08

Mons, Belgium

Location

Investigating site BE03

Ottignies, Belgium

Location

Investigating site FR01

Amiens, France

Location

Investigating site FR04

Bordeaux, France

Location

Investigating site FR06

Évry, France

Location

Investigating site FR03

Paris, France

Location

Investigating site FR02

Rouen, France

Location

Investigating site NL02

Maastricht, Netherlands

Location

Investigating site NL01

Rotterdam, Netherlands

Location

MeSH Terms

Conditions

Fractures, Bone; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: December 25, 2012
• Study Start: June 1, 2012
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2019
• Last Updated: June 11, 2020

Record last verified: 2020-06

Locations

BE (9); FR (5); NL (2)