PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells

PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells

The purpose of this study is to analyze the safety and feasibility of direct administration intrafemoral mesenchymal stem cells (MSCs) in vitro expanded autologous treatment of patients with femoral osteonecrosis.

Inclusion Criteria:

• Age between 18 and 70 years
• Clinical diagnosis and imaging (Rx and NMR) of idiopathic osteonecrosis of the femoral head
• Stadiums <IIIC ARCO ranking

Exclusion Criteria:

• Those on investigator judgment not in a good position to tolerate the procedure.
• Clinical criteria and anesthetics that contraindicate surgery (eg ASA IV-V)
• Serious illness uncontrolled
• Pregnant women
• Patients with HIV infection +
• Acute infection (in the previous 15 days) or chronic (other than HIV)
• Previous treatments of osteonecrosis
• Active or previous neoplastic disease (last 5 years) except for patients undergoing allogeneic haematopoietic progenitors who are in complete remission after 2 years after transplantation.
• Lack of informed consent or revocation thereof.