Expanded autologous mesenchymal stem cells obtained under GMP conditions fixed in allogenic bone tissue
Not reported
(i) Group 1: instrumented spinal fusion and the tissue engineering product composed by “ex vivo” expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in spinal fusion (ii) Group 2: standard treatment of instrumented spinal fusion and patient's bone iliac crest
(i) Experimental group 1: lowest dose of NeoFuse (ii) Experimental group 2: middle dose of NeoFuse (iii) Experimental group 3: highest dose of NeoFuse (MPCs) (iv) Control group: autologous bone graft
Cell suspension of MSCs from bone marrow aspirate expanded in vitro in a specific medium enriched with platelet lysate without addition of animal products
Not reported
(i) Autologous mesenchymal stem cells arranged in a phosphate ceramic