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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02890537
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : September 7, 2016
Sponsor:
Collaborators:
University of Liege
Bone Therapeutics S.A
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Avascular Necrosis of Femur Head Drug: Core decompression/PREOB® implantation Drug: Core decompression/BMC implantation Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Osteonecrosis of the Femoral Head by Implantation of Preosteoblastic Cells: a Randomized, Controlled, Single Blind Pilot Study
Study Start Date : October 2003
Actual Primary Completion Date : May 2011
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteonecrosis

Arm Intervention/treatment
Experimental: Core decompression/PREOB® implantation
Core decompression/autologous osteoblastic cells (PREOB®) implantation
Drug: 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).

Active Comparator: Core decompression/BMC implantation
Core decompression/bone marrow concentrate (BMC) implantation
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).




Primary Outcome Measures :
  1. Percentage of responder subjects [ Time Frame: 24 months ]
    Response defined as the absence of progression to fractural stage (ARCO stage III or higher) & a clinically significant pain improvement

  2. 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: 60 months ]

Secondary Outcome Measures :
  1. Percentage of responder subjects [ Time Frame: 3, 6, 12 and 36 months ]
  2. Percentage of subjects progressing to fractural stage (ARCO stage III or higher), as assessed by conventional X-ray [ Time Frame: 3, 6, 12, 24 and 36 months ]
  3. Change from baseline in VAS pain score [ Time Frame: 3, 6, 12, 18, 24, 36 and 48 months ]
  4. Change from baseline in WOMAC® score [ Time Frame: 3, 6, 12, 18, 24, 36 and 48 months ]
  5. Change from baseline in Lequesne score [ Time Frame: 3, 6, 12, 18, 24, 36 and 48 months ]
  6. Proportion of subjects undergoing a total hip arthroplasty [ Time Frame: 6, 12, 24 and 36 months ]
  7. Time to hip fracture [ Time Frame: 36 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890537


Locations
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Belgium
Investigative site 01
Brussels, Belgium
Investigative site 02
Liege, Belgium
Sponsors and Collaborators
Erasme University Hospital
University of Liege
Bone Therapeutics S.A
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Responsible Party: Erasme University Hospital
ClinicalTrials.gov Identifier: NCT02890537    
Other Study ID Numbers: 2003/281
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Erasme University Hospital:
Osteonecrosis
Femoral Head
Hip
Orthopedics
Bone
Musculoskeletal Disorders
Additional relevant MeSH terms:
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Osteonecrosis
Legg-Calve-Perthes Disease
Femur Head Necrosis
Necrosis
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases