P136. Randomized, Prospective Clinical Trial to Evaluate Efficacy and Safety in Lumbar Fusion Surgery of Implantation of Autologous Bone Marrow Mesenchymal Cells Expanded Ex Vivo and Combined with Allogeneic Bone Tissue, Compared with Autologous Iliac Crest Graft; Part II: Clinical Findings

PURPOSE The objective of this study was to clinically evaluate patients who underwent implantation of a scaffold of heterologous human cancellous bone tissue seeded with autologous bone marrow mesenchymal cells expanded ex vivo (XCEL-MT-OSTEO-ALPHA; EudraCT No.2010-023999-12; NCT01552707), and to compare results with those obtained in control patients who underwent the standard surgical procedure of autologous iliac crest graft. STUDY DESIGN/SETTING Multicenter, prospective, open-label, randomized, parallel, and single-dose phase I-II study (EudraCT No.2010-023999-12). PATIENT SAMPLE Sixty-five patients (mean age, 61.05 years; 65.6% female) with degenerative spondylolisthesis (79.4%) and/or disc disease at L4–L5 were recruited. OUTCOME MEASURES Patients were evaluated clinically (lumbar and sciatic visual analog scale [VAS] and Oswestry disability index [ODI]) before and 3, 6 and 12 months after surgery. The percentage of patients with an improved or worsened clinical status at each visit was determined based on the minimal clinically important difference (MCID) defined in the literature for each variable (changes in VAS and ODI of ≥3 and ≥12 points, respectively). METHODS Clinical variables and the percentage of patients with an improved/worsened clinical status were compared between treatment (Group A) and control (Group B) groups. RESULTS Improvement in lumbar VAS at 3, 6 and 12 months was -3.62 (3.2); -3.51 (3.06); -5.27 (3.2). 56.6% of the patients showed a MCID improvement at 3 months (Group A 50% vs Group B 60.7%); 56.9% at 6 months (58.3% vs 53.8%); 58% at 12 months (64% vs 52%). Improvement in sciatic VAS at 3, 6 and 12 months was -4.83 (3.18); -5.27 (3.2); -4.61 (3.56). MCID improvement 67.0% at 3 months (70.8% vs 64.3%), 95.9% at 6 months (95.8% vs 95.8%), 64% at 12 months (68% vs 60%). Improvement in Oswestry at 3 months was -12.71 (14.76); at 6 months -16.2 (16.92); at 12 months -17.8 (16.66). At 3 months, 60.8% showed a MCID improvement (68.2 vs 53.6%); at 6 months 64.7% (62.5% vs 65.4%) and at 12 months 62.3% (61.5% vs 61.5%). There were no significant differences in clinical variables between groups. There was no significant difference in the percentage of patients with improved/worsened clinical status between groups. CONCLUSIONS No significant differences in clinical outcome were observed between lumbar disease patients treated with XCEL-MT-OSTEO-ALPHA and those who received the standard treatment of autologous iliac crest graft. Comparable rates of improvement/worsening in pain and disability were observed for both treatments. Treatment with XCEL-MT-OSTEO-ALPHA appears to have no detrimental clinical effects in lumbar disease patients. FDA DEVICE/DRUG STATUS XCEL-MT-OSTEO-ALPHA (Not approved for this indication) The objective of this study was to clinically evaluate patients who underwent implantation of a scaffold of heterologous human cancellous bone tissue seeded with autologous bone marrow mesenchymal cells expanded ex vivo (XCEL-MT-OSTEO-ALPHA; EudraCT No.2010-023999-12; NCT01552707), and to compare results with those obtained in control patients who underwent the standard surgical procedure of autologous iliac crest graft. Multicenter, prospective, open-label, randomized, parallel, and single-dose phase I-II study (EudraCT No.2010-023999-12). Sixty-five patients (mean age, 61.05 years; 65.6% female) with degenerative spondylolisthesis (79.4%) and/or disc disease at L4–L5 were recruited. Patients were evaluated clinically (lumbar and sciatic visual analog scale [VAS] and Oswestry disability index [ODI]) before and 3, 6 and 12 months after surgery. The percentage of patients with an improved or worsened clinical status at each visit was determined based on the minimal clinically important difference (MCID) defined in the literature for each variable (changes in VAS and ODI of ≥3 and ≥12 points, respectively). Clinical variables and the percentage of patients with an improved/worsened clinical status were compared between treatment (Group A) and control (Group B) groups. Improvement in lumbar VAS at 3, 6 and 12 months was -3.62 (3.2); -3.51 (3.06); -5.27 (3.2). 56.6% of the patients showed a MCID improvement at 3 months (Group A 50% vs Group B 60.7%); 56.9% at 6 months (58.3% vs 53.8%); 58% at 12 months (64% vs 52%). Improvement in sciatic VAS at 3, 6 and 12 months was -4.83 (3.18); -5.27 (3.2); -4.61 (3.56). MCID improvement 67.0% at 3 months (70.8% vs 64.3%), 95.9% at 6 months (95.8% vs 95.8%), 64% at 12 months (68% vs 60%). Improvement in Oswestry at 3 months was -12.71 (14.76); at 6 months -16.2 (16.92); at 12 months -17.8 (16.66). At 3 months, 60.8% showed a MCID improvement (68.2 vs 53.6%); at 6 months 64.7% (62.5% vs 65.4%) and at 12 months 62.3% (61.5% vs 61.5%). There were no significant differences in clinical variables between groups. There was no significant difference in the percentage of patients with improved/worsened clinical status between groups. No significant differences in clinical outcome were observed between lumbar disease patients treated with XCEL-MT-OSTEO-ALPHA and those who received the standard treatment of autologous iliac crest graft. Comparable rates of improvement/worsening in pain and disability were observed for both treatments. Treatment with XCEL-MT-OSTEO-ALPHA appears to have no detrimental clinical effects in lumbar disease patients.