Osteonecrosis of the femoral head safely healed with autologous, expanded, bone marrow-derived mesenchymal stromal cells in a multicentric trial with minimum 5 years follow-up
EntityUAM. Departamento de Cirugía; Instituto de Investigación Sanitaria Hospital Universitario de La Paz (IdiPAZ)
PublisherMDPI, Basel, Switzerland
10.3390/jcm10030508Journal of Clinical Medicine 10.3 (2021): 508
Funded byThe research leading to these results has received funding from the European Research Council under the European Union’s Seventh Framework Programme (FP7/FP7-HEALTH-2009): REBORNE Project, Grant Agreement 241876. Work in EFS and stromalab was also supported by the Agence Nationale pour la Recherche for support of the national infrastructure: “ECELLFRANCE"
Subjectsfemoral head osteonecrosis; bone regeneration; expanded MSC; clinical trial; Medicina
Rights© 2021 The authors
Esta obra está bajo una Licencia Creative Commons Atribución 4.0 Internacional.
Background: Osteonecrosis (ON) of the femoral head represents a potentially severe disease of the hip where the lack of bone regeneration may lead to femoral head collapse and secondary osteoarthritis, with serious pain and disability. The aim of this European, multicentric clinical trial was to prove safety and early efficacy to heal early femoral head ON in patients through minimally invasive surgical implantation of autologous mesenchymal stromal cells (MSC) expanded from bone marrow (BM) under good manufacturing practices (GMP). Methods: Twenty-two patients with femoral head ON (up to ARCO 2C) were recruited and surgically treated in France, Germany, Italy and Spain with BM-derived, expanded autologous MSC (total dose 140 million MSC in 7 mL). The investigational advanced therapy medicinal product (ATMP) was expanded from BM under the same protocol in all four countries and approved by each National Competent Authority. Patients were followed during two years for safety, based on adverse events, and for efficacy, based on clinical assessment (pain and hip score) and imaging (X-rays and MRIs). Patients were also reviewed after 5 to 6 years at latest follow-up for final outcome. Results: No severe adverse event was recalled as related to the ATMP. At 12 months, 16/20 per protocol and 16/22 under intention-to-treat (2 drop-out at 3 and 5 months) maintained head sphericity and showed bone regeneration. Of the 4 hips with ON progression, 3 required total hip replacement (THR). At 5 years, one patient (healed at 2 years visit) was not located, and 16/21 showed no progression or THR, 4/21 had received THR (all in the first year) and 1 had progressed one stage without THR. Conclusions: Expanded MSCs implantation was safe. Early efficacy was confirmed in 80% of cases under protocol at 2 years. At 5 years, the overall results were maintained and 19% converted to THR, all in the first year
Google Scholar:Gómez-Barrena, Enrique - Padilla-Eguiluz, Norma G. - Rosset, Philippe - Hernigou, Philippe - Baldini, Nicola - Ciapetti, Gabriela - Gonzalo-Daganzo, Rosa M. - Avendaño Solá, Cristina - Rouard, Hélène - Giordano, Rosaria - Dominici, Massimo - Schrezenmeier, Hubert - Layrolle, Pierre - REBORNE Consortium
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