Autologous Osteoblastic Cells Implantation to Early Stage Osteonecrosis of the Femoral Head (PREOB-ON2)

Free University of Brussels (ULB)

Status and phase: Completed; Phase 2

Conditions: Avascular Necrosis of Femur Head

Treatments: Drug: Core decompression/BMC implantation; Drug: Core decompression/PREOB® implantation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02890537

2003/281

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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82 participants in 2 patient groups

Core decompression/PREOB® implantation

Experimental group

Description:

Core decompression/autologous osteoblastic cells (PREOB®) implantation

Treatment:

Drug: Core decompression/PREOB® implantation

Core decompression/BMC implantation

Active Comparator group

Description:

Core decompression/bone marrow concentrate (BMC) implantation

Treatment:

Drug: Core decompression/BMC implantation