银川干细胞2017.ppt

1、,会议内容,青年论坛开幕式、大会报告分会场（1/2/3）报告分会场（4/5/6）报告,CMV-specific T cell transfer promotes the quantitative and qualitive immune recovery for refractory CMV infection after haploidentical stem cell transplantation（Peking University Peoples Hospital）,Background: Cytomegalovirus (CMV) infection is a major cause

2、 of morbidity and mortality in allogeneic stem cell transplant (allo-SCT) recipients，particularly in those patients who undergo haploidentical stem cell transplantation (haplo-SCT). Adoptive immunotherapies with CMV-specific T cells have been developed for the treatment of CMV infection，and several

3、clinical trials have established the safety and efficacy of adoptive T cells for prophylaxis and treatment of CMV infection.However，few experiences have been reported about CMV-specific T cells in adoptive therapy post haplo-SCT.,Methods: A total of 32 patients with refractory CMV infection prospect

4、ively accepted adoptive CMV-specific T cells infusion following haplo-SCT were enrolled. Another group of 32 patients with non-refractory CMV infection after haplo-SCT was selected as controls. We analyzed the phenotypical and functional characteristics of CMV-specific T cells and their subsets befo

5、re and after immunotherapy in the refractory CMV cohort， and also in the non-refractory CMV cohort. We aimed to(i) evaluate the safety and antiviral activity of CMV-specific T cells for refractory CMV infection in haplo-SCT recipients.,Results:Of the 32 treated patients，27 cleared CMV within 4 weeks

6、 posttransfer and were grouped into the early effective group. The remaining 5 patients who still experienced CMV recurrence after 4 weeks post adoptive transfer were grouped into the late effective group. In the early effective group，in vivo expansion of CMV-specific T cells，as well as improved cyt

7、okine production and proliferation ability of CMV-specific T cells were observed following cellular therapy. However，in remaining 5 patients who had CMV recurrence after 4 weeks post-transfer，neither the quantity nor the function of CMV-specific T cells were reversed.,Conclusions: Adoptive transfer

8、of CMV-specific T cells would promote the quantitative and functional recovery of CMVspecific T cells that would guard against refractory CMV infection after haplo-SCT.,18 casesIn 83% of cases CMV infection was cleared or viral burden was significantly reduced Viral control was associated with in vi

9、vo expansion of CMV-specific T cells,异体干细胞治疗牙周炎的基础及转化临床研究王松灵首都医科大学,在大型动物模型-小型猪上建立了牙周炎模型。用自体、异体牙源干细胞成功修复牙周炎致牙周骨缺损。牙源性干细胞再生牙周的效果比非牙源性干细胞好；牙髓干细胞保持细胞的干性及抗凋亡衰老能力明显优于其他干细胞。牙髓干细胞悬液注射组可以用于相对轻型的牙周病组织再生。18例异体牙髓干细胞治疗慢性牙周炎临床研究表明有明显牙周组织再生，无副作用。通过建立牙源干细胞库、牙髓干细胞注射液新药应用到临床,人牙髓间充质干细胞注射液,自体干细胞技术的临床应用肖海蓉石桂来博雅干细胞科技有限公司

10、,博雅集团旗下 Cesca 公司(纳斯达克上市企业)是全球领先的干细胞自动化设备供应商，拥有全球市场占有率超过 60%的脐带血干细胞自动化分离设备(AutoXpress)及全球唯一的自动化液氮存储装置(BioArchive)。利用自主研发的手术室即时系统(ResQTM60、 MarrowXpressTM)，Cesca公司开展了自体骨髓单核细胞治疗重症下肢缺血、急性心肌梗死、骨折不愈合等疾病的临床研究。其中，重症下肢缺血的 1/II 期临床试验(n=17)已经完成， 患者无治疗相关副作用，1年无截肢生存率为 82.4%，旁侧血管数量与尺寸等指标显著改善； FDA 已经批准开展 III 期临床试验

11、。,临床级脐带间充质细胞制备及鉴定方法研究袁艳鹏等首都医科大学宣武医院,目的：在 GLP 实验室中制备并鉴定临床级脐带间充质细胞方法：新鲜获取的脐带去除血管并进行充分清洗，获得的华通胶(Whartons jelly)机械分离后分别进行直接贴壁法和不同的酶消化法，比较获取脐带间充质细胞的数量差别；用不同的无血清培养基进行培养比较细胞形态是否良好， 得到最佳形态的脐带间充质细胞。体外培养第 3 代后进行脐带间充质细胞质检，包括细胞活性，生长曲线，无菌检测，人类相关病毒、支原体、内毒素检测，染色体核型分析， FACS 免疫表型检测及分化能力检测。 不同消化方法获取细胞数之间比较采用两样本配对 t 检

12、验。,结果:胶原酶消化获得的脐带间充质细胞数(5.3106/ml)与胶原酶+0.25胰酶消化法(2.53105/ml)及直接贴壁法(2.6105/ml)之间存在显著性差异(P0.0001)；MesenCult-ACF Medium （上海钰博生物）培养获得的 UC-MSC 形态最佳； UC-MSC 质检细胞活性冻存前达99.8， 冻存复苏后达 99； 无细菌/支原体/乙肝病毒/丙肝病毒/梅毒螺旋体/艾滋病毒/肺炎支原体/EB 病毒/巨细胞病毒污染； 内毒素检测结果均1EU； CD73/CD90/CD105 阳性率达98， CD34/CD45/HLA-DR 呈阴性，阳性率2；染色体核型分析无突变或缺失； UC-MSC具有成脂/成骨/成软骨方向分化的能力。,细胞治疗产品临床技术审评的考虑,杨焕国家食品药品监督管理总局生物制品临床部药品审评中心国家食品药品监督管理总局,细胞制品研究与评价技术指导原则（征求意见稿）,干细胞研究管理办法（试行）解读,王锦倩国家卫生计生委科教司技术处处长,THE END,