This prospective study sought to evaluate the healing quality of implanted ultraporous β-tricalcium phosphate sown with expanded autologous mesenchymal stromal cells (MSCs) into femoral defects during revision hip arthroplasty. A total of 37 osseous defects in 37 patients were treated and evaluated concerning bone regeneration. Nineteen subjects received β-tricalcium phosphate graft material serving as a carrier of expanded autologous MSCs (the trial group A), nine subjects received β-tricalcium phosphate graft material only (the study group B) and nine subjects received cancellous allografts only (the control group C). Clinical and radiographic evaluations were scheduled at 6 weeks, 3, 6, and 12 months post-operatively, and performed at the most recent visit as well. All observed complications were recorded during follow-up to assess the use of an ultraporous β-tricalcium phosphate synthetic graft material combined with expanded MSCs in bone defect repair. The resulting data from participants with accomplished follow-up were processed and statistically evaluated with a Freeman-Halton modification of the Fischer's exact test, a P < 0.05 value was considered to be significant. Whereas no significant difference was observed between the trial group A with β-tricalcium phosphate synthetic graft material serving as a carrier of expanded autologous MSCs and control group C with cancellous impaction allografting in terms of the bone defect healing, significant differences were documented between the study group B with β-tricalcium phosphate graft material only and control group C. Regarding adverse effects, six serious events were recorded during the clinical trial with no causal relationship to the cell product. β-tricalcium phosphate synthetic graft material serving as a carrier of expanded autologous MSCs appears safe and promotes the healing of bone defects in a jeopardized and/or impaired microenvironment. This clinical trial was registered at the EU Clinical Trials Register before patient recruitment (Registration number: EudraCT number 2012-005599-33; Date of registration: 2013-02-04).

• Klíčová slova
• bone defect, cell therapy, mesenchymal stromal cells, scaffold,
• MeSH
• dospělí MeSH
• femur cytologie   zranění   fyziologie   chirurgie   MeSH
• fosforečnany vápenaté chemie   terapeutické užití   MeSH
• kostní náhrady chemie   terapeutické užití   MeSH
• lidé středního věku MeSH
• lidé MeSH
• mezenchymální kmenové buňky cytologie   MeSH
• regenerace kostí * MeSH
• senioři MeSH
• tkáňové podpůrné struktury chemie   MeSH
• transplantace mezenchymálních kmenových buněk metody   MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze II MeSH
• práce podpořená grantem MeSH
• srovnávací studie MeSH
• Názvy látek
• beta-tricalcium phosphate MeSH Prohlížeč
• fosforečnany vápenaté MeSH
• kostní náhrady MeSH

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).

• MeSH
• autologní transplantace * MeSH
• femur patofyziologie   chirurgie   MeSH
• fosforečnany vápenaté terapeutické užití   MeSH
• lidé středního věku MeSH
• lidé MeSH
• mezenchymální kmenové buňky MeSH
• náhrada kyčelního kloubu * MeSH
• regenerace kostí fyziologie   MeSH
• remodelace kosti účinky léků   fyziologie   MeSH
• senioři MeSH
• tkáňové podpůrné struktury chemie   MeSH
• trabekulární kostní tkáň účinky léků   patofyziologie   chirurgie   MeSH
• transplantace mezenchymálních kmenových buněk metody   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze II MeSH
• Názvy látek
• beta-tricalcium phosphate MeSH Prohlížeč
• fosforečnany vápenaté MeSH