To determine the efficacy and safety of PREOB®, a proprietary population of autologous bone-forming cells, in the treatment of early stage non-traumatic osteonecrosis of the femoral head.
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Efficacy Endpoint
- Percentage of treatment responders at Month 24,
a treatment responder at the studied timepoint being defined as a patient who
responded both:
--Clinically, i.e., if at the studied timepoint, the WOMAC® VA3.1 pain
subscale score of the study treated hip improved from baseline by at least the
minimal clinically important difference (MCID),
and
--Radiologically, i.e., if at the studied timepoint, the study treated hip did
not progress to fractural stages (ARCO III or higher), as assessed by
conventional X-ray.
Secondary outcome
- Percentage of treatment responders at Month 6, 12 and 18, and over the
24-month follow-up period
- Percentage of clinical responders at Month 1, 3, 6, 12, 18 and 24, and over
the 24*month follow-up period
- Percentage of radiological responders at Month 6, 12, 18 and 24, and over the
24*month follow-up period
- Absolute change from baseline in WOMAC® VA3.1 total score and composite pain,
stiffness, and function
subscales scores
- Time to hip fracture
- Time to hip arthroplasty
- Percentage of patients requiring hip arthroplasty
Background summary
Non traumatic osteonecrosis of the femoral head is a disorder that mainly
affect young patients (30-60 years old). With the current therapeutic options
progression is so severe that nearly half of the patients will need total hip
replacement before the age of 40. Previous studies have shown that implantation
of autologous bone-marrow cells could lead to improved osteogenesis. Based on
these observations, a proprietary cell population of bone-forming cells
(PREOB®) has been developed. Phase II has been completed. A phase III clinical
study is now needed to confirm the efficacy and safety of PREOB® treatment.
Study objective
To determine the efficacy and safety of PREOB®, a proprietary population of
autologous bone-forming cells, in the treatment of early stage non-traumatic
osteonecrosis of the femoral head.
Study design
Double-blind placebo controlled intervention study.
Intervention
Study group: Core decompression with a small-diameter trephine and implantation
of 5ml PREOB® solution (at concentration of 4*10^6 cells/ml - PREOB®20) into
the necrotic lesion.
Control group: Core decompression with a small-diameter trephine and
implantation of 5ml Placebo solution into the necrotic lesion.
Study burden and risks
In 9 or 10 visits 5 blood samples will be taken, 8 bilateral questionnaires
have to be filled in. 5 or 6 or 5 X-ray of hips (plus one in the occasion
confirmation of hip fracture is indicated) and 1 CT will be performed. 4 times
bilateral MRI. The associated additional patient load beside the standard
procedure (core decompression, medical imaging, laboratory lag and
questionnaire) will be the bone marrow harvesting (or sham procedure) and blood
harvesting. 3 times additional consultation + bilateral (except for prosthesis)
medical imaging (X-ray and MRI) + laboratory and questionnaire for this trial.
Rue Auguste Piccard 37
Gosselies 6041
BE
Rue Auguste Piccard 37
Gosselies 6041
BE
Listed location countries
Age
Inclusion criteria
Men and women, aged 18 to 70 years old, diagnosed with:
- an ARCO stage I osteonecrosis with the sum of coronal and sagittal necrotic angles superior to 190 degrees which is symptomatic (pain * 20 mm on the WOMAC® VA3.1 pain subscale during the 48 hours preceding the screening)
- an ARCO stage II osteonecrosis with the sum of coronal and sagittal necrotic angles superior to 190 degrees which can be either symptomatic or asymptomatic
- an ARCO stage II osteonecrosis with the sum of coronal and sagittal necrotic angles inferior to 190 degrees which is symptomatic (pain * 20 mm on the WOMAC® VA3.1 pain subscale during the 48 hours preceding)
Exclusion criteria
ARCO stage III and IV osteonecrosis of the femoral head on the hip which is evaluated, and confirmed by conventional X-ray and and MRI of the hip.
Osteoarthritis on the hip. Bone fracture that might interfere with study evaluation.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-012929-11-NL |
| ClinicalTrials.gov | NCT01529008 |
| CCMO | NL29848.000.12 |