| Autor: |
Blanco JF; Orthopaedic Surgery and Traumatology Department, University Hospital of Salamanca, 37007 Salamanca, Spain.; Biomedical Research Institute of Salamanca (IBSAL), 37007 Salamanca, Spain.; Regenerative Medicine and Cell Therapy Network Center of Castilla y Leon, Gerencia Regional de Salud, 47011 Valladolid, Spain.; Health Outcomes-Oriented Cooperative Research Networks in Advanced Therapies (RICORS TERAV), Instituto de Salud Carlos III, 28220 Madrid, Spain.; Department of Medicine, University of Salamanca, 37007 Salamanca, Spain., Garcia-Garcia FJ; Orthopaedic Surgery and Traumatology Department, University Hospital of Salamanca, 37007 Salamanca, Spain., Villarón EM; Biomedical Research Institute of Salamanca (IBSAL), 37007 Salamanca, Spain.; Regenerative Medicine and Cell Therapy Network Center of Castilla y Leon, Gerencia Regional de Salud, 47011 Valladolid, Spain.; Health Outcomes-Oriented Cooperative Research Networks in Advanced Therapies (RICORS TERAV), Instituto de Salud Carlos III, 28220 Madrid, Spain.; Cell Therapy Unit, Hematology Department, University Hospital of Salamanca, 37007 Salamanca, Spain., da Casa C; Biomedical Research Institute of Salamanca (IBSAL), 37007 Salamanca, Spain., Fidalgo H; Biomedical Research Institute of Salamanca (IBSAL), 37007 Salamanca, Spain., López-Parra M; Biomedical Research Institute of Salamanca (IBSAL), 37007 Salamanca, Spain.; Regenerative Medicine and Cell Therapy Network Center of Castilla y Leon, Gerencia Regional de Salud, 47011 Valladolid, Spain.; Health Outcomes-Oriented Cooperative Research Networks in Advanced Therapies (RICORS TERAV), Instituto de Salud Carlos III, 28220 Madrid, Spain.; Cell Therapy Unit, Hematology Department, University Hospital of Salamanca, 37007 Salamanca, Spain., Santos JA; Biomedical Research Institute of Salamanca (IBSAL), 37007 Salamanca, Spain.; Radiology Department, University Hospital of Salamanca, 37007 Salamanca, Spain.; Department of Biomedical Sciences and Diagnostics, University of Salamanca, 37007 Salamanca, Spain., Sánchez-Guijo F; Biomedical Research Institute of Salamanca (IBSAL), 37007 Salamanca, Spain.; Regenerative Medicine and Cell Therapy Network Center of Castilla y Leon, Gerencia Regional de Salud, 47011 Valladolid, Spain.; Health Outcomes-Oriented Cooperative Research Networks in Advanced Therapies (RICORS TERAV), Instituto de Salud Carlos III, 28220 Madrid, Spain.; Department of Medicine, University of Salamanca, 37007 Salamanca, Spain.; Cell Therapy Unit, Hematology Department, University Hospital of Salamanca, 37007 Salamanca, Spain. |
| Abstrakt: |
(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) standards. Study medication consisted of a suspension of autologous BM-derived MSCs (suspended in a solution of 5-10 mL of saline and 5% human albumin) in a single dose of 0.5-1 × 10 6 cells/kg of the patient, administered intraosseously with a trocar and under radioscopic control. Per-protocol monitoring of patients included a postoperative period of 12 months, with a clinical and radiological assessment that included the visual analog scale (VAS), the Harris scale, the SF-36, and the radiological evolution of both hips. In addition, all patients were further followed up for eight years to assess the need for long-term total hip replacement (THR) surgery. (3) Results: Median age of patients included was 48.38 ± 7.38 years, and all patients were men. Autologous MSCs were expanded in all cases. There were no adverse effects related to cell administration. Regarding efficacy, both VAS and ODI scores improved after surgery. Radiologically, 12.5% of patients improved at the end of follow-up, whereas 50% improved clinically. No adverse effects related to the procedure were recorded, and none of the patients needed THR surgery within the first year after MSC therapy. (4) Conclusions: The use of autologous MSCs for patients with ONFH disease is feasible, safe in the long term, and potentially effective. |
