Autologous Osteoblastic Cells Implantation to Early Stage Osteonecrosis of the Femoral Head

Phase 2

Completed

• Conditions: Avascular Necrosis of Femur Head
• Interventions: Drug: Core decompression/PREOB® implantation; Drug: Core decompression/BMC implantation

• Registration Number: NCT02890537
• Lead Sponsor: Erasme University Hospital

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 2B study aims at demonstrating the efficacy and safety of PREOB® in the treatment of early stage osteonecrosis of the femoral head. The primary goal of this study was to investigate the safety and efficacy of the implantation of the investigational product PREOB® (human autologous bone marrow-derived osteoblastic cells) in comparison to bone marrow concentrate (BMC) when implanted at the osteonecrotic lesion of the femoral head, with a follow-up period of up to 5 years.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Primary Completion: 2011-05
• Study Completion: 2015-01
• Status Verified: 2016-08
• Study First Submitted: 2016-08-25
• Study First Submitted QC: 2016-08-31
• Last Update Submitted: 2016-08-31
• Study First Posted: 2016-09-07
• Last Update Posted: 2016-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• ARCO stage I or II non-traumatic osteonecrosis of the femoral head, confirmed by conventional X-ray and magnetic resonance imaging (MRI) of the hip
• Aged 18 or higher
• Ability to provide a written, dated and signed informed consent prior to any study-related procedure to understand and comply with study requirements

Exclusion Criteria

• Evidence of malignant disorder in the past five years
• Positive serology for hepatitis B, hepatitis C, HIV
• Patient unable to undergo a MRI

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Core decompression/PREOB® implantation	Core decompression/PREOB® implantation	Core decompression/autologous osteoblastic cells (PREOB®) implantation
Core decompression/BMC implantation	Core decompression/BMC implantation	Core decompression/bone marrow concentrate (BMC) implantation

Primary Outcome Measures

Name	Time	Method
Percentage of responder subjects	24 months	Response defined as the absence of progression to fractural stage (ARCO stage III or higher) \& a clinically significant pain improvement
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	60 months

Secondary Outcome Measures

Name	Time	Method
Percentage of responder subjects	3, 6, 12 and 36 months
Percentage of subjects progressing to fractural stage (ARCO stage III or higher), as assessed by conventional X-ray	3, 6, 12, 24 and 36 months
Change from baseline in VAS pain score	3, 6, 12, 18, 24, 36 and 48 months
Change from baseline in WOMAC® score	3, 6, 12, 18, 24, 36 and 48 months
Change from baseline in Lequesne score	3, 6, 12, 18, 24, 36 and 48 months
Proportion of subjects undergoing a total hip arthroplasty	6, 12, 24 and 36 months
Time to hip fracture	36 months

Trial Locations

Locations (2)

Investigative site 01; 🇧🇪 Brussels, Belgium

Investigative site 02; 🇧🇪 Liege, Belgium