干细胞技术结合新型可降解材料进行腰椎融合的临床研究
Clinical study of lumbar fusion by hybrid construct of stem cells technique and biodegradable material
摘要目的 探索富集骨髓干细胞技术进行腰椎融合治疗脊柱疾病的疗效.方法 腰椎退行性疾患患者56例,根据行下腰椎后路融合手术中植骨融合材料的不同,分为富集骨髓干细胞快速复合多孔β-磷酸三钙(13-TCP)复合材料组(复合材料组,n=30)和自体髂骨植骨组(自体骨组,n=26).对复合材料组富集前后骨髓体积、有核细胞(NCs)和碱性磷酸酶染色阳性的细胞集落(CFUs/ALP+)计数,分析富集效率;结合随访、影像学检查和Oswestry功能评分等综合评定疗效.结果 复合材料组术中平均抽取骨髓血(249±31)ml,富集技术平均回收(43±11)ml,NCs由(15.9±3.3)x106/ml浓缩至(44.1±10.8)×106/ml,富集后CFUs/ALP+数量由(118±86)/ml浓缩至(486±305)/ml.临床随访(26.3±7.5)个月.两组中患者的年龄、性别、病种分布及融合节段无显著差异,复合材料组与自体骨组融合率分别为93.3%和96.2%(P>0.05).两组手术时间的差异也无统计学意义(P>0.05).复合材料组术中患者的总出血量高于自体骨组(P<0.01),但术中自体血回输可以将接近1/2的术中出血回输给患者.复合材料组术后骨髓采集部无血肿和慢性疼痛,伤口渗出或局部肿胀4例,均自行愈合;而自体骨组术后髂骨采集部血肿(15.4%)和慢性疼痛(26.9%),无伤口渗出的情况.两组间Oswestry功能评分的差异无统计学意义(P>0.05).结论 富集骨髓干细胞技术可在术中一期应用,提高骨髓MSCs的浓度,安全、快速.富集骨髓干细胞快速复合多孔β-磷酸三钙后,可作为腰椎后外侧融合的植骨替代品.
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abstractsObjecfive To explorer the effectiveness of enriched bone marrow stem cells technique for lumbar fusion.Methods With the randomization and control principles,2 graft materials[Enrichment bone marrow mesenchymal stem ceHs hybriding with β-tri calcium phosphate(composite graft group),autologous iliac crest bone graft(autograft group)]were compared in posterior lumbar fusion procedures.56 patients with degenerative disc disease,lumbar instability or spinal stenosis,were included.The volume of cells suspension in pre-and post-enrichment and the number of nucleated eeBs(NCs)were identified.The number of osteoprogenitor cells was estimated by counting the colony-forming units which express alkaline phosphatase(CFUs/ALP+).Then the efficiency of the enrichment was evaluated.Clinical follow-up with roentgenogram and Oswestry scale scores was performed for outcome evaluation.Results (249±31)ml bone marrow per patient from bilateral iliac crests was aspirated peri-operatively. About(43±11)ml enriched bane marrow was collected.The number of NCs was concentrated from(15.9±3.3)×106/ml to(44.1±10.8)×106/ml,CFUs/ALP+ was significantly increased from(118±86)/ml to(486±305)/ml.The follow-up was about(26.3±7.5)months.There was no significant differences in age,gender,disease and fusion segments between the two groups.The fusion rate was 93.3% and 96.2% for composite graft group and autograft group,respectively(X2=0.2146,P=0.6432).There was no difference in operation time between the two group(t=0.5243,P=0.6022),but blood loss in composite graft group was more than that in autograft group(t=6.4664,P<0.01).Cell salvage for auto-transfusion could transfuse back half of the blood loss during operation.No hematoma or chronic soreness in the bone marrow donor sites of composite graft group occurred,but a little exudation or moderate swelling in the wound happened in 4 cases which disapeared under medical treatment.Meanwhile,15.4% patients had hematoma in the iliac bone donor site and 26.9% patients had chronic soreness,but no case had wound problem in autograft group.As for Oswestry scale scores,there was no significant difference between the two groups.Conclusions The enrichment technique of autologous bone marrow stem cells can greatly increase the concentration of MSCs.It is a rapid and safe method used peri-operatively.The composite material of enriched MSCs and porous β-TCP iS a good bone substitute in posterior spinal fusion.
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