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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary:

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.

Detailed Summary:
Sponsor: Bone Therapeutics S.A

Current Primary Outcome:

• Change from baseline in WOMAC VA3.1 pain subscale score [ Time Frame: 24 months ]
• Percentage of patients progressing to fractural stages (ARCO stage III or higher), as assessed by conventional X-ray [ Time Frame: 24 months ]

Original Primary Outcome:

• Pain scores on visual analog scale (WOMAC VA3.1 pain subscale) [ Time Frame: at 24 months ]
  WOMAC VA3.1 pain subscale
• Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: at screening, D-28, D-21, D0, 1, 3, 6, 12, 18, 24, 36, 48 months ]
  During the whole study, subjects will be systematically assessed for the potential occurence of any AE or SAE, related to the product or related to the procedure, using patient open questionnaire, physical examination (including body mass index and vital signs), and laboratory measurements
• Radiological progression to fractural stages [ Time Frame: at 24 month ]
  Radiological progression to fractural stages as assessed by conventional X-ray of the hip with reference to the ARCO classification

Current Secondary Outcome:

• Change from baseline in WOMAC VA3.1 total score and composite pain, stiffness, and function [ Time Frame: 24 months ]
• Percentage of patients progressing to fractural stages (ARCO stage III or higher), as assessed by conventional X-ray [ Time Frame: 24 months ]
• Conventional X-ray [ Time Frame: 24 months ]
• Time to hip fracture [ Time Frame: 24 months ]
• Time to hip arthroplasty [ Time Frame: 24 months ]
• Percentage of patients requiring hip arthroplasty [ Time Frame: 24 months ]

Original Secondary Outcome: Secondary efficacy endpoints: WOMAC VA3.1 composite pain, stiffness, and function subscales, & time to arthroplasty [ Time Frame: at 24 months ]

Information By: Bone Therapeutics S.A

Dates:
Date Received: February 2, 2012
Date Started: November 2011
Date Completion: January 2019
Last Updated: May 23, 2016
Last Verified: May 2016