Evaluation of Mesenchymal Stem Cells to Treat Avascular Necrosis of the Hip

To assess the safety and feasibility of an in situ single injection of a high dose of autologous bone marrow-derived, in vitro expanded Mesenchymal stem cells, and its contribution to the resolution of the early stages of avascular osteonecrosis of the femoral head.

Inclusion criteria

Age 18 to 65, both sexes

• Early avascular necrosis of the fem oral head (MRI diagnosis): Ficat and Arlet 0, 1, or 2 (Steinberg stages 0, I, IIA, IIB, or IIC)
• Sym ptom atic osteonecrosis with less than 6 months of evolution
• Able to provide informed consent, and signed informed consent
• Medical health care coverage

Exclusion criteria

• Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control.
• Participation in another therapeutic trial in the previous 3 m onths
• Stages 3 or m ore (Ficat and Arlet) or III or m ore (Steinberg) of severe fem oral head osteonecrosis,primarily based on diagnosis by im aging (X-Rays, MRI).
• Flattening or collapse of the fem oral head (Steinberg stage IV) or articular cartilage collapse at the time of core decompression surgery.
• Septic arthritis.
• Stress fracture.
• Non-osteonecrosis metabolic bone diseases (particularly Paget's disease of bone, osteogenesis imperfecta, primary hyperparathyroidism , fibrous dysplasia monostotic, polyostotic McCune-Albright syndrome] and osteopetrosis).
• Any active bisphosphonate treatment or any history of intravenous (IV) treatment.
• History of prior or concurrent diagnosis of HIV-, Hepatitis-B- or Hepatitis-C-infection
• Active hepatitis B or hepatitis C infection at the time of screening.
• Known allergies to products involved in the production process of MSC.
• History of neoplasia or current neoplasia in any organ.
• Corticoid or immunosuppressive therapy more than one week in the two months prior to study inclusion
• Patients who will require continuous, systemic, high dose corticosteroid therapy (more than 7.5 m g/day) within 6 months after surgery.
• Patients who are in active treatment for cancer or blood dyscrasia, or have received chemotherapy, radiotherapy or immunotherapy in the past 2 years.
• History of regular alcohol consumption exceeding 2 drinks/day within 6 months of screening and/or history of illicit drug use.
• Serum AST (SGO T)/ALT (SGPT) > 2.5 X (institutional standard range).
• MRI-incompatible internal devices (pacemakers, aneurysm clips, etc).
• Body mass index (BMI) of 40 kg/m ² or greater.
• Patients unable to tolerate general anesthesia defined as an American Society of Anesthesiologists (ASA) criteria of > 2.
• Insulin dependent diabetes
• Patients with poorly controlled diabetes mellitus (HbA1C > 8%), or with peripheral neuropathy, or known concomitant vascular problems.
• Patients receiving treatment with hematopoietic growth factors or anti-vasculogenesis or antiangiogenesis treatment.
• Traumatic osteonecrosis.
• Adult in the care of a guardian (Subject legally protected)
• Im possibility to meet at the appointments for the clinical follow up.