Phase 3 Study on Autologous Osteoblastic Cells Implantation to Early Stage Osteonecrosis of the Femoral Head

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:
NCT01529008
First received: February 2, 2012
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

Non-traumatic osteonecrosis is a painful disorder of the hip characterized by a necrosis of the osteomedullary tissue, which leads to subchondral bone collapse and joint destruction. Core decompression is currently the treatment of choice for early stage osteonecrosis of the femoral head. This method consists in decompressing the rigid intra-osseous chamber to promote revascularization, thus halting progression of the disease and stimulating repair. Still this treatment remains highly controversial, since the success rates of the first studies have not been repeated.

The exact pathology mechanisms involved in osteonecrosis have not yet be fully elucidated. Several hypotheses have been evoked, including fat embolism, trabecular bone microfractures, microvascular tamponade and, more recently, impaired bone and/or mesenchymal cells recruitment.

Three studies have indicated the potential clinical benefits of cell-based approaches for the treatment of osteonecrosis (Hernigou 1997, Hernigou & Beaujean 2002, Gangji et al. 2004). This is on the basis of these observations that a proprietary population of autologous osteoblastic cells (PREOB®) has been developed.

This Phase 3 study aims at demonstrating the efficacy and safety of PREOB® in the treatment of early stage osteonecrosis of the femoral head. More specifically, the purpose of the study is to demonstrate that core decompression/PREOB® implantation into the necrotic lesion is superior to core decompression/placebo implantation in relieving hip symptoms and halting (or reverting) radiological progression of the disease.


Condition Intervention Phase
Osteonecrosis of the Femoral Head
Drug: Core decompression/PREOB® implantation
Drug: Core decompression/placebo implantation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3, Pivotal, Multicentre, Randomised, Double-blind Controlled Study to Evaluate the Efficacy and Safety of Autologous Osteoblastic Cells (PREOB®) Implantation in Early Stage Non Traumatic Osteonecrosis of the Femoral Head

Resource links provided by NLM:


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

Primary Outcome Measures:
  • WOMAC VA3.1 pain subscale [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Radiological progression to fractural stages, as demonstrated by conventional X-ray with reference to the ARCO Staging [ Time Frame: 24 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: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • WOMAC VA3.1 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Time to arthroplasty [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: November 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Core decompression/PREOB® implantation Drug: Core decompression/PREOB® implantation
All patients will undergo a core decompression under general anesthesia combined with the implantation of PREOB® into the necrotic lesion (single administration).
Placebo Comparator: Core decompression/placebo implantation Drug: Core decompression/placebo implantation
All patients will undergo a core decompression under general anesthesia combined with the implantation of placebo into the necrotic lesion (single administration).

  Eligibility

Ages Eligible for Study:   18 Years to 70 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 ARCO Stage I or II osteonecrosis of the femoral head, confirmed by conventional X-ray and MRI of the hip, associated with pain
  • Normal hematology function

Exclusion Criteria:

  • Positive serology for hepatitis B, hepatitis C, HIV, syphilis, HTLV-1
  • Presence or previous history, of risk factors for diseases caused by prions
  • Patients with poorly controlled diabetes mellitus, severe arterial disease and/or neuropathy
  • Renal or hepatic impairment
  • Presence or previous history of solid or hematological neoplasia or bone marrow transplantation
  • Osteonecrosis due to trauma or accident, hemoglobinopathy, coagulopathy, Gaucher's disease, and dysbaric osteonecrosis
  • Osteonecrosis stage III or IV
  • Low back pain, knee pain, bone fracture(s) which may potentially interfere with evaluation
  • Patients who are candidates for any imminent joint replacement on the evaluated hip
  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: NCT01529008

Contacts
Contact: Enrico Bastianelli, MD, MBA preob.on3@bonetherapeutics.com
Contact: Valérie De Saedeleer preob.on3@bonetherapeutics.com

Locations
Belgium
Investigative site BE06 Recruiting
Aalst, Belgium
Investigative site BE01 Recruiting
Anderlecht, Belgium
Investigative site BE09 Not yet recruiting
Antwerpen, Belgium
Investigative site BE04 Recruiting
Brugge, Belgium
Investigative site BE02 Recruiting
Brussels, Belgium
Investigative site BE05 Recruiting
Dendermonde, Belgium
Investigative site BE13 Recruiting
Edegem, Belgium
Investigative site BE14 Recruiting
Genk, Belgium
Investigative site BE15 Recruiting
Gent, Belgium
Investigative site BE10 Recruiting
Gent, Belgium
Investigative site BE16 Recruiting
Hasselt, Belgium
Investigative site BE11 Recruiting
Kortrijk, Belgium
Investigative site BE08 Recruiting
Liège, Belgium
Investigative site BE04 Recruiting
Oostende, Belgium
Investigative site BE07 Recruiting
Roeselare, Belgium
Investigative site BE03 Recruiting
Sint-Niklaas, Belgium
Investigative site BE12 Recruiting
Yvoir, Belgium
France
Investigative site FR04 Recruiting
Amiens, France
Investigative site FR08 Not yet recruiting
Bordeaux, France
Investigative site FR06 Not yet recruiting
Limoges, France
Investigative site FR02 Recruiting
Nancy, France
Investigative site FR07 Not yet recruiting
Nantes, France
Investigative site FR03 Recruiting
Paris, France
Investigative site FR01 Recruiting
Saint-Etienne, France
Germany
Investigative site DE05 Recruiting
Dresden, Germany
Investigative site DE01 Not yet recruiting
Hannover, Germany
Investigative site DE02 Recruiting
Köln, Germany
Investigative site DE04 Recruiting
Würzburg, Germany
Netherlands
Investigative site NL01 Recruiting
Rotterdam, Netherlands
Investigative site NL02 Not yet recruiting
Utrecht, Netherlands
Sponsors and Collaborators
Bone Therapeutics S.A
  More Information

No publications provided

Responsible Party: Bone Therapeutics S.A
ClinicalTrials.gov Identifier: NCT01529008     History of Changes
Other Study ID Numbers: PREOB-ON3
Study First Received: February 2, 2012
Last Updated: November 4, 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
Germany: Paul-Ehrlich-Institut

Keywords provided by Bone Therapeutics S.A:
Osteonecrosis
Femoral Head
Hip
Orthopedics
Bone
Musculoskeletal Disorders

Additional relevant MeSH terms:
Osteonecrosis
Bone Diseases
Musculoskeletal Diseases
Necrosis
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014