自体或异体脂肪间充质基质细胞联合磷酸三钙生物材料用于治疗长骨萎缩性骨不连的手术治疗的疗效和安全性：一项 II 期临床试验。
Efficacy and safety of autologous or allogeneic mesenchymal stromal cells from adult adipose tissue expanded and combined with tricalcium phosphate biomaterial for the surgical treatment of atrophic nonunion of long bones: a phase II clinical trial.
机构信息
Institut de Teràpia Regenerativa Tissular, Centro Médico Teknon, Barcelona, Spain.
Instituto Médico Arriaza, Grupo INCIDE Universidad da Coruña, A Coruña, Spain.
出版信息
J Transl Med. 2024 May 24;22(1):493. doi: 10.1186/s12967-024-05280-x.
BACKGROUND
Autologous bone grafting is the standard treatment for the surgical management of atrophic nonunion of long bones. Other solutions, such as bone marrow mesenchymal stem cells (BM-MSC) combined with phospho-calcium material, have also been used. Here we evaluate the safety and early efficacy of a novel procedure using autologous or allogenic adipose tissue mesenchymal stromal cells (AT-MSC) seeded in a patented tricalcium phosphate-based biomaterial for the treatment of bone regeneration in cases of atrophic nonunion.
METHODS
This was a prospective, multicentric, open-label, phase 2 clinical trial of patients with atrophic nonunion of long bones. Biografts of autologous or allogenic AT-MSC combined with a phosphate substrate were manufactured prior to the surgical procedures. The primary efficacy was measured 6 months after surgery, but patients were followed for 12 months after surgery and a further year out of the scope of the study. All adverse events were recorded. This cohort was compared with a historical cohort of 14 cases treated by the same research team with autologous BM-MSC.
RESULTS
A total of 12 patients with atrophic nonunion of long bones were included. The mean (SD) age was 41.2 (12.1) years and 66.7% were men. Bone healing was achieved in 10 of the 12 cases (83%) treated with the AT-MSC biografts, a percentage of healing similar (11 of the 14 cases, 79%) to that achieved in patients treated with autologous BM-MSC. Overall, two adverse events, in the same patient, were considered related to the procedure.
CONCLUSIONS
The results of this study suggest that AT-MSC biografts are safe for the treatment of bone regeneration in cases of atrophic nonunion and reach high healing rates.
TRIAL REGISTRATION
Study registered with EUDRA-CT (2013-000930-37) and ClinicalTrials.gov (NCT02483364).
背景
自体骨移植是治疗长骨萎缩性骨不连的标准治疗方法。其他解决方案，如骨髓间充质干细胞（BM-MSC）与磷酸钙材料结合，也已被应用。在这里，我们评估了一种使用自体或同种异体脂肪组织间充质干细胞（AT-MSC）接种在专利磷酸三钙基生物材料中治疗萎缩性骨不连的新型方法的安全性和早期疗效。
方法
这是一项针对长骨萎缩性骨不连患者的前瞻性、多中心、开放标签、2 期临床试验。在手术前制备了自体或同种异体 AT-MSC 与磷酸底物的生物移植物。主要疗效在手术后 6 个月测量，但患者在手术后 12 个月和研究范围外的进一步一年进行随访。记录所有不良事件。该队列与同一研究小组用自体 BM-MSC 治疗的 14 例患者的历史队列进行了比较。
结果
共纳入 12 例长骨萎缩性骨不连患者。平均（SD）年龄为 41.2（12.1）岁，66.7%为男性。用 AT-MSC 生物移植物治疗的 12 例患者中有 10 例（83%）达到骨愈合，与用自体 BM-MSC 治疗的患者（14 例中的 11 例，79%）相似。总体而言，同一患者的 2 例不良事件被认为与该程序有关。
结论
本研究结果表明，AT-MSC 生物移植物治疗萎缩性骨不连的骨再生是安全的，且愈合率较高。
试验注册
在 EUDRA-CT（2013-000930-37）和 ClinicalTrials.gov（NCT02483364）注册。
Zotero 插件