Osteonecrosis of the Femoral Head MedDRA version: 18.1 Level: PT Classification code 10031264 Term: Osteonecrosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: PREOB®
Product Code: PREOB®
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: PREOB® cells
Current Sponsor code: PREOB® cells
Concentration unit: ml millilitre(s)
Concen
Sponsors
Bone Therapeutics S.A.
Eligibility
Sex/Gender
All
Inclusion 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 or b.ARCO stage II associated with WOMAC® VA3.1 pain score =20 mm if necrotic angle sum =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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 arthritis 5.Bone fracture or bone infection at hip under evaluation 6.Patients who are candidates for any predictable joint replacement on the hip that is evaluated 7.Active hepatitis B (defined as positive HBs Ag and/or positive PCR), active hepatitis C (defined as positive PCR), positive serology for HIV , or Syphilis1, or HTLV-11 8.Presence, or previous history, of risks factors for diseases caused by prions, and recipients of grafts of cornea, sclera, and dura mater 9.History of blood loss exceeding 450 ml (incl. donations) within 1 month of screening 10.Renal impairment defined by an estimated creatinine clearance value 9% 13.Global sepsis 14.Allergy to gentamicin or porcine collagen or any substance or device the patient might be exposed to in the context of the study related interventions (i.e., bone marrow harvesting and implantation), as judged by the Investigator 15. History of hypersensitivity to human biological material, including blood and blood derived products, documented clinically or by laboratory tests 16.Current or past history of solid or haematological neoplasia (except for basal cell carcinoma of the skin and for carcinoma in situ of the cervix that has been treated with no evidence of recurrence) 17.History of bone marrow transplantation 18.Patients with a life expectancy less than 2 years, as judged by the Investigator 19.Patients treated by core decompression of the hip under evaluation within 6 months of screening 20.Treatment with doses of prednisolone =15 mg per day (or equivalent) within 1 month from screening, and patients with anticipated needs of daily corticoid doses =15 mg prednisone (or equivalent) in the 6-month period following PREOB®/Placebo implantation 21.Illicit drug or alcohol abuse interfering with patient’s ability to understand and comply with study requirements, as judged by the Investigator 22.Pregnancy 23.Breast-feeding 24.Patients unable to undergo MRI, e.g. patients with pace-maker, intra-ocular or intra-cerebral metallic foreign bodies, and mechanical artificial heart valves
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study objectives are to demonstrate that Core decompression/PREOB® implantation is superior to Core decompression/Placebo implantation in relieving clinical hip symptoms and halting (or reverting) radiological progression (to fractural stages III or higher) at 24 months. Patients will be assessed using the Western Ontario and McMaster Universities (WOMAC®) Index. Central radiological evaluation will include conventional bilateral X-ray and MRI of the hips to assess ARCO Staging and to measure the sum of the coronal and sagittal necrotic angles.;Secondary Objective: Exploratory Efficacy Endpoints include • Change from baseline in necrotic lesion of the treated hip volume as assessed by MRI • Radiological evolution of contralateral hip over time as assessed by conventional X-ray • Assessment of serum biomarkers • Impact of osteonecrosis etiology: corticoid-induced, alcohol abuse, or idiopathic forms of osteonecrosis ;Primary end point(s): Primary Efficacy Endpoints • Change form baseline in WOMAC® VA3.1 pain susbcale score, and • Percentage of patients progressing to fractural stages (ARCO III or higher) as assessed by conventional X-ray Safety Endpoints During the whole study, subjects will be systematically assessed for the potential occurrence of any AE or SAE, related to the product or related to the procedure, using patient interview, physical examination (including body mass index and vital signs), and laboratory measurements.;Timepoint(s) of evaluation of this end point: Primary Efficacy Endpoints: at month 24 Safety endpoints: at every visit, up to month 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Endpoints • Change from baseline in WOMAC® VA3.1 total score and composite pain, stiffness, and function subscales scores • Percentage of patients progressing to fractural stages (ARCO stage III or higher), as assessed by conventional X-ray • Time to hip fracture • Time to arthroplasty • Percentage of patients requiring hip arthroplasty ;Timepoint(s) of evaluation of this end point: Secondary Efficacy Endpoints: up to month 24 | — |
Countries
Belgium, Germany, United Kingdom
Contacts
Public ContactClinical Trial Information
Bone Therapeutics S.A.
Outcome results
None listed