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 sites68 target enrollmentNovember 19, 2013

Overview

No summary available.

Registry

who.int

Start Date

November 19, 2013

End Date

July 4, 2019

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Bone Therapeutics S.A.

•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
•d.Associated with corticosteroid and/or with alcohol abuse and/or idiopathic.
•4\.Normal haematology function, defined as: leukocytes \=3000/mm3, absolute neutrophils count \=1500/mm3, platelets \=140,000/mm3, and haemoglobin concentration \=10g/dl (peripheral blood test)
•Are the trial subjects under 18? no

•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\.Blood not qualifying for PREOB® production, including active hepatitis B (defined as positive HBs Ag and/or positive PCR), or active hepatitis C (defined as positive PCR), positive serology for HIV, or Syphilis, or HTLV\-1, and any other tests that may be required by the authorities in case of a new disease outbreak that can affect the safety of the physicians and operators at the time of patient screening.
•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 \< 30 ml per min, calculated with the Cockcroft\-Gault formula