Autologous Osteoblastic Cells Implantation to Early Stage Osteonecrosis of the Femoral Head (PREOB-ON2)
Primary Purpose
Avascular Necrosis of Femur Head
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Core decompression/PREOB® implantation
Core decompression/BMC implantation
Sponsored by
About this trial
This is an interventional treatment trial for Avascular Necrosis of Femur Head focused on measuring Osteonecrosis, Femoral Head, Hip, Orthopedics, Bone, Musculoskeletal Disorders
Eligibility 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
Sites / Locations
- Investigative site 01
- Investigative site 02
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Core decompression/PREOB® implantation
Core decompression/BMC implantation
Arm Description
Core decompression/autologous osteoblastic cells (PREOB®) implantation
Core decompression/bone marrow concentrate (BMC) implantation
Outcomes
Primary Outcome Measures
Percentage of responder subjects
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
Secondary Outcome Measures
Percentage of responder subjects
Percentage of subjects progressing to fractural stage (ARCO stage III or higher), as assessed by conventional X-ray
Change from baseline in VAS pain score
Change from baseline in WOMAC® score
Change from baseline in Lequesne score
Proportion of subjects undergoing a total hip arthroplasty
Time to hip fracture
Full Information
NCT ID
NCT02890537
First Posted
August 25, 2016
Last Updated
August 31, 2016
Sponsor
Erasme University Hospital
Collaborators
University of Liege, Bone Therapeutics S.A
1. Study Identification
Unique Protocol Identification Number
NCT02890537
Brief Title
Autologous Osteoblastic Cells Implantation to Early Stage Osteonecrosis of the Femoral Head
Acronym
PREOB-ON2
Official Title
Treatment of Osteonecrosis of the Femoral Head by Implantation of Preosteoblastic Cells: a Randomized, Controlled, Single Blind Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Erasme University Hospital
Collaborators
University of Liege, Bone Therapeutics S.A
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Avascular Necrosis of Femur Head
Keywords
Osteonecrosis, Femoral Head, Hip, Orthopedics, Bone, Musculoskeletal Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Core decompression/PREOB® implantation
Arm Type
Experimental
Arm Description
Core decompression/autologous osteoblastic cells (PREOB®) implantation
Arm Title
Core decompression/BMC implantation
Arm Type
Active Comparator
Arm Description
Core decompression/bone marrow concentrate (BMC) implantation
Intervention Type
Drug
Intervention Name(s)
Core decompression/PREOB® implantation
Intervention Description
All subjects received a core decompression under general anesthesia combined with the implantation of PREOB® into the necrotic lesion (single administration).
Intervention Type
Drug
Intervention Name(s)
Core decompression/BMC implantation
Intervention Description
All subjects received a core decompression under general anesthesia combined with the implantation of BMC into the necrotic lesion (single administration).
Primary Outcome Measure Information:
Title
Percentage of responder subjects
Description
Response defined as the absence of progression to fractural stage (ARCO stage III or higher) & a clinically significant pain improvement
Time Frame
24 months
Title
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 Measure Information:
Title
Percentage of responder subjects
Time Frame
3, 6, 12 and 36 months
Title
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
Title
Change from baseline in VAS pain score
Time Frame
3, 6, 12, 18, 24, 36 and 48 months
Title
Change from baseline in WOMAC® score
Time Frame
3, 6, 12, 18, 24, 36 and 48 months
Title
Change from baseline in Lequesne score
Time Frame
3, 6, 12, 18, 24, 36 and 48 months
Title
Proportion of subjects undergoing a total hip arthroplasty
Time Frame
6, 12, 24 and 36 months
Title
Time to hip fracture
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Investigative site 01
City
Brussels
Country
Belgium
Facility Name
Investigative site 02
City
Liege
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
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Autologous Osteoblastic Cells Implantation to Early Stage Osteonecrosis of the Femoral Head
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