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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2015-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Avascular Necrosis of Femur Head

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Core decompression/PREOB® implantation

Core decompression/autologous osteoblastic cells (PREOB®) implantation

Group Type EXPERIMENTAL

Core decompression/PREOB® implantation

Intervention Type DRUG

All subjects received a core decompression under general anesthesia combined with the implantation of PREOB® into the necrotic lesion (single administration).

Core decompression/BMC implantation

Core decompression/bone marrow concentrate (BMC) implantation

Group Type ACTIVE_COMPARATOR

Core decompression/BMC implantation

Intervention Type DRUG

All subjects received a core decompression under general anesthesia combined with the implantation of BMC into the necrotic lesion (single administration).

Interventions

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Core decompression/PREOB® implantation

All subjects received a core decompression under general anesthesia combined with the implantation of PREOB® into the necrotic lesion (single administration).

Intervention Type DRUG

Core decompression/BMC implantation

All subjects received a core decompression under general anesthesia combined with the implantation of BMC into the necrotic lesion (single administration).

Intervention Type DRUG

Eligibility Criteria

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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