EUCTR2009-012929-11-DE
Active, not recruiting
Phase 1
Phase III, pivotal, multicentre, randomised, double-blind controlled Study to evaluate the Efficacy and Safety of Autologous Osteoblastic Cells (PREOB®) Implantation in Early Stage Non Traumatic Osteonecrosis of the Femoral Head - PREOB-ON3
Bone Therapeutics S.A.0 sites118 target enrollmentDecember 22, 2011
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Osteonecrosis of the Femoral Head
- Sponsor
- Bone Therapeutics S.A.
- Enrollment
- 118
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Men or women between 18 and 70 years (inclusive)
- •2\. Ability to provide a written, dated, and signed informed consent prior to any study related procedure and to understand and comply with study requirements
- •3\.Diagnosis of Osteonecrosis:
- •a.ARCO stage I associated with WOMAC® VA3\.1 pain score \=20 mm and
- •necrotic angle sum \=190° based on sagittal and coronal MRI views
- •b.ARCO stage II associated with WOMAC® VA3\.1 pain score \=20 mm if
- •necrotic angle sum \<190°
- •based on sagittal and coronal MRI views
- •c.ARCO stage II associated or not with pain if necrotic angle sum is \=
- •190° based on sagittal and coronal MRI views
Exclusion Criteria
- •1\.Exclusively diaphyseal or metaphyseal osteonecrotic lesion
- •2\.Traumatic or hyperbaric osteonecrosis, or osteonecrosis associated
- •with hemoglobinopathy or coagulopathy (e.g., thalassemia, sickle cell
- •disease,…), or Gaucher's disease
- •3\.Osteoarthritis at the hip under evaluation defined as Kellgrens stage \=
- •2, as assessed by the Central Radiologist
- •4\.Patients suffering from any medical conditions interfering with
- •patient's pain evaluation of the hip under evaluation, such as knee
- •5\.Bone fracture or bone infection at hip under evaluation.
- •6\.Patients who are candidates for any predictable joint replacement on
Outcomes
Primary Outcomes
Not specified
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