title: Utilizing Autologous Multipotent Mesenchymal Stromal Cells and β-Tricalcium Phosphate Scaffold in Human Bone Defects: A Prospective, Controlled Feasibility Trial.
abstract: The purpose of this prospective controlled study was to compare healing quality following the implantation of ultraporous β-tricalcium phosphate, containing either expanded autologous mesenchymal stromal cells (trial group, 9 patients) or β-tricalcium phosphate alone (control group, 9 patients), into femoral defects during revision total hip arthroplasty. Both groups were assessed using the Harris Hip Score, radiography, and DEXA scanning at 6 weeks and 3, 6, and 12 months postoperatively. A significant difference in the bone defect healing was observed between both groups of patients (P < 0.05). In the trial group, trabecular remodeling was found in all nine patients and in the control group, in 1 patient only. Whereas, over the 12-month follow-up period, no significant difference was observed between both groups of patients in terms of the resorption of β-tricalcium phosphate, the significant differences were documented in the presence of radiolucency and bone trabeculation through the defect (P < 0.05). Using autologous mesenchymal stromal cells combined with a β-tricalcium phosphate scaffold is a feasible, safe, and effective approach for management of bone defects with compromised microenvironment. The clinical trial was registered at the EU Clinical Trials Register before patient recruitment has begun (EudraCT number 2012-005599-33).
authors.affiliation: Department of Orthopaedic Surgery, Charles University in Prague, Faculty of Medicine in Hradec Králové, Šimkova 870, 500 38 Hradec Králové, Czech Republic.
authors.forename: Pavel
authors.initials: P
authors.lastname: Šponer
authors.affiliation: Department of Oncology and Radiotherapy, Charles University in Prague, Faculty of Medicine in Hradec Králové, Šimkova 870, 500 38 Hradec Králové, Czech Republic.
authors.forename: Stanislav
authors.identifier: 0000-0002-8567-0745
authors.initials: S
authors.lastname: Filip
authors.affiliation: Department of Orthopaedic Surgery, University Hospital in Hradec Králové, Sokolská 581, 500 05 Hradec Králové, Czech Republic.
authors.forename: Tomáš
authors.initials: T
authors.lastname: Kučera
authors.affiliation: Department of Radiology, University Hospital in Hradec Králové, Sokolská 581, 500 05 Hradec Králové, Czech Republic.
authors.forename: Jindra
authors.initials: J
authors.lastname: Brtková
authors.affiliation: Department of Orthopaedic Surgery, University Hospital in Hradec Králové, Sokolská 581, 500 05 Hradec Králové, Czech Republic.
authors.forename: Karel
authors.initials: K
authors.lastname: Urban
authors.affiliation: Institute for Clinical Biochemistry and Diagnostics, Charles University in Prague, Faculty of Medicine in Hradec Králové, Šimkova 870, 500 38 Hradec Králové, Czech Republic.
authors.forename: Vladimír
authors.initials: V
authors.lastname: Palička
authors.affiliation: Institute of Experimental Medicine, Academy of Sciences of the Czech Republic, Vídeňská 1083, 142 20 Prague, Czech Republic; Department of Neuroscience, 2nd Faculty of Medicine, Charles University in Prague, V Úvalu 84, 150 06 Prague, Czech Republic.
authors.forename: Zuzana
authors.initials: Z
authors.lastname: Kočí
authors.affiliation: Institute of Experimental Medicine, Academy of Sciences of the Czech Republic, Vídeňská 1083, 142 20 Prague, Czech Republic.
authors.forename: Michael
authors.initials: M
authors.lastname: Syka
authors.affiliation: Department of Medical Biophysics, Charles University in Prague, Faculty of Medicine in Hradec Králové, Šimkova 870, 500 38 Hradec Králové, Czech Republic.
authors.forename: Aleš
authors.identifier: 0000-0002-2397-3847
authors.initials: A
authors.lastname: Bezrouk
authors.affiliation: Institute of Experimental Medicine, Academy of Sciences of the Czech Republic, Vídeňská 1083, 142 20 Prague, Czech Republic; Department of Neuroscience, 2nd Faculty of Medicine, Charles University in Prague, V Úvalu 84, 150 06 Prague, Czech Republic.
authors.forename: Eva
authors.initials: E
authors.lastname: Syková
mesh_terms: D000368:Aged; D019644:Arthroplasty, Replacement, Hip; D001861:Bone Regeneration / Q000502:physiology; D016723:Bone Remodeling / Q000187:drug effects / Q000502:physiology; D002130:Calcium Phosphates / Q000627:therapeutic use*; D000071556:Cancellous Bone / Q000187:drug effects / Q000503:physiopathology / Q000601:surgery; D005260:Female; D005269:Femur / Q000503:physiopathology / Q000601:surgery; D006801:Humans; D008297:Male; D045164:Mesenchymal Stem Cell Transplantation / Q000379:methods*; D059630:Mesenchymal Stem Cells; D008875:Middle Aged; D054457:Tissue Scaffolds / Q000737:chemistry; D014182:Transplantation, Autologous; D016896:Treatment Outcome
chemical_list: D002130:Calcium Phosphates; C485817:beta-tricalcium phosphate