Phase III Study of Autologous Osteoblastic Cells Implantation to Non Traumatic Osteonecrosis of the Femoral Head.

Inclusion Criteria:

• Ability to provide a written, dated, and signed informed consent prior to any study procedure for participation in the study and transmission of personal "coded" data
• Ability to understand and comply with study requirements
• presence of hip pain consistent with non-traumatic osteonecrosis of the femoral head with a WOMAC pain subscale ≥ 20 mm at screening/Inclusion Visit
• Diagnosis of ARCO Stage I or II non-traumatic osteonecrosis of the femoral head, confirmed by conventional X-ray, and MRI of the hip

• Normal marrow function, defined in a peripheral blood testing as:leukocytes

  • 3000/mL; absolute neutrophils count ≥ 1500/mL; platelets ≥ 140 000/mL
• Female patients must be post-menopausal, or surgically sterile, or for women of childbearing potential, using reliable contraceptive method.

Exclusion Criteria:

• Positive serology for hepatitis B
• Positive serology for hepatitis C
• Positive serology for HIV
• Positive serology for syphilis
• Positive serology for HTLV-1
• Renal impairment
• Hepatic impairment
• Hemoglobin level < 10 g/dL
• presence or previous history, of risk factors for diseases caused by prions i.e. patients diagnosed with Creutzfeldt-Jakob disease or variant Creutzfeldt-Jakob disease (including bovine spongiform encephalopathy), or having a family history of non-iatrogenic Creutzfeldt-Jakob disease); history of rapid progressive dementia or degenerative neurological disease (including those of unknown origin); recipients of hormones derived from the human pituitary gland (such as growth hormones); and recipients of grafts of cornea, sclera, and dura mera
• patients with poorly controlled diabetes mellitus
• Patients witn concomitant peripheral arterial disease and/or neuropathy
• Clinically relevant abnormal ECG (12-lead) at screening, as judged by the investigator
• Known history of severe acute or chronic allergy requiring medical therapy
• Current or past history of solid or hematological neoplasia or bone marrow transplantation
• Subject unable to undergo MRI (i.e. patients with pace-maker, intra-ocular or intra-cerebral metallic foreign bodies, and mechanical artificial heart valves)
• osteonecrosis due to trauma or accident
• osteonecrosis due to sickle cell anemia or other hemoglobinopathies and coagulopathies, Gaucher disease, and dysbaric osteonecrosis
• Normal MRI: fat-like signal intensity marrow in the femoral head; physeal scar not to be confused with the infarct margin
• Osteonecrosis stage III or IV
• Osteoarthritis defined as Kellgrens stage I or above on conventional X-ray
• Any other focal or diffuse bone marrow lesion
• A bone fracture that might interfere with the study evaluation.
• A fracture of subchondral bone plate
• A fracture of subchondral trabecular bone
• Known severe osteoporosis
• Infection of bone
• Low back pain which may potentially interfere with evaluation
• Knee pain (trauma, osteonecrosis, osteoarthritis, meniscus problems, complex regional pain syndrome) on the evaluated side that may potentially interfere with hip evaluation, as judged by the investigator
• Patients who are candidates for any imminent joint replacement on the evaluated hip