Long-Term Results of a Phase I/II Clinical Trial of Autologous Mesenchymal Stem Cell Therapy for Femoral Head Osteonecrosis.

ABSTRACT: (1) Background: Osteonecrosis of the femoral head (ONFH) is characterized by impaired vascularization with ischemia resulting in bone cell death, leading to the deterioration of the hip joint. Mesenchymal stem/stromal cells (MSCs) are an attractive potential therapeutic approach in this setting. The aim of this study is to evaluate the clinical improvement in terms of pain and quality of life, as well as the safety of the procedure during the follow-up of patients. (2) Methods: A Phase I-II Open-Label Non-Randomized Prospective clinical trial was conducted. Eight patients with idiopathic ONFH and stage < IIC in the ARCO classification were included. Four weeks before therapy, 40 mL of autologous bone marrow was obtained, and MSCs were expanded under Good-Manufacturing-Practice (GMP) standa

SUBMITTER: Blanco JF 

PROVIDER: S-EPMC10051457 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature