دورية أكاديمية
Phase II Multicenter, Randomized, Double-Blind Controlled Study of Efficacy and Safety of Umbilical Cord-Derived Mesenchymal Stromal Cells in the Prophylaxis of Chronic Graft-Versus-Host Disease After HLA-Haploidentical Stem-Cell Transplantation.
| العنوان: | Phase II Multicenter, Randomized, Double-Blind Controlled Study of Efficacy and Safety of Umbilical Cord-Derived Mesenchymal Stromal Cells in the Prophylaxis of Chronic Graft-Versus-Host Disease After HLA-Haploidentical Stem-Cell Transplantation. |
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| المؤلفون: | Gao L; Lei Gao, Yanqi Zhang, Jia Liu, Peiyan Kong, Yao Liu, Li Gao, Cheng Zhang, Lidan Zhu, Qin Wen, Ping Wang, Xinghua Chen, Jiangfan Zhong, and Xi Zhang, Third Military Medical University, Chongqing; Baoyang Hu, Chinese Academy of Sciences, Beijing; Shifeng Lou, Second Affiliated Hospital of Chongqing Medical University, Chongqing; Yi Su, General Hospital of Chengdu Military Region of People's Liberation Army, Chengdu; Tonghua Yang, Yunnan Provincial People's Hospital; Huimin Li, Affiliated Hospital of Kunming Medical College, Kunming, China; and Jiangfan Zhong, University of Southern California, Los Angeles, CA., Zhang Y; Lei Gao, Yanqi Zhang, Jia Liu, Peiyan Kong, Yao Liu, Li Gao, Cheng Zhang, Lidan Zhu, Qin Wen, Ping Wang, Xinghua Chen, Jiangfan Zhong, and Xi Zhang, Third Military Medical University, Chongqing; Baoyang Hu, Chinese Academy of Sciences, Beijing; Shifeng Lou, Second Affiliated Hospital of Chongqing Medical University, Chongqing; Yi Su, General Hospital of Chengdu Military Region of People's Liberation Army, Chengdu; Tonghua Yang, Yunnan Provincial People's Hospital; Huimin Li, Affiliated Hospital of Kunming Medical College, Kunming, China; and Jiangfan Zhong, University of Southern California, Los Angeles, CA., Hu B; Lei Gao, Yanqi Zhang, Jia Liu, Peiyan Kong, Yao Liu, Li Gao, Cheng Zhang, Lidan Zhu, Qin Wen, Ping Wang, Xinghua Chen, Jiangfan Zhong, and Xi Zhang, Third Military Medical University, Chongqing; Baoyang Hu, Chinese Academy of Sciences, Beijing; Shifeng Lou, Second Affiliated Hospital of Chongqing Medical University, Chongqing; Yi Su, General Hospital of Chengdu Military Region of People's Liberation Army, Chengdu; Tonghua Yang, Yunnan Provincial People's Hospital; Huimin Li, Affiliated Hospital of Kunming Medical College, Kunming, China; and Jiangfan Zhong, University of Southern California, Los Angeles, CA., Liu J; Lei Gao, Yanqi Zhang, Jia Liu, Peiyan Kong, Yao Liu, Li Gao, Cheng Zhang, Lidan Zhu, Qin Wen, Ping Wang, Xinghua Chen, Jiangfan Zhong, and Xi Zhang, Third Military Medical University, Chongqing; Baoyang Hu, Chinese Academy of Sciences, Beijing; Shifeng Lou, Second Affiliated Hospital of Chongqing Medical University, Chongqing; Yi Su, General Hospital of Chengdu Military Region of People's Liberation Army, Chengdu; Tonghua Yang, Yunnan Provincial People's Hospital; Huimin Li, Affiliated Hospital of Kunming Medical College, Kunming, China; and Jiangfan Zhong, University of Southern California, Los Angeles, CA., Kong P; Lei Gao, Yanqi Zhang, Jia Liu, Peiyan Kong, Yao Liu, Li Gao, Cheng Zhang, Lidan Zhu, Qin Wen, Ping Wang, Xinghua Chen, Jiangfan Zhong, and Xi Zhang, Third Military Medical University, Chongqing; Baoyang Hu, Chinese Academy of Sciences, Beijing; Shifeng Lou, Second Affiliated Hospital of Chongqing Medical University, Chongqing; Yi Su, General Hospital of Chengdu Military Region of People's Liberation Army, Chengdu; Tonghua Yang, Yunnan Provincial People's Hospital; Huimin Li, Affiliated Hospital of Kunming Medical College, Kunming, China; and Jiangfan Zhong, University of Southern California, Los Angeles, CA., Lou S; Lei Gao, Yanqi Zhang, Jia Liu, Peiyan Kong, Yao Liu, Li Gao, Cheng Zhang, Lidan Zhu, Qin Wen, Ping Wang, Xinghua Chen, Jiangfan Zhong, and Xi Zhang, Third Military Medical University, Chongqing; Baoyang Hu, Chinese Academy of Sciences, Beijing; Shifeng Lou, Second Affiliated Hospital of Chongqing Medical University, Chongqing; Yi Su, General Hospital of Chengdu Military Region of People's Liberation Army, Chengdu; Tonghua Yang, Yunnan Provincial People's Hospital; Huimin Li, Affiliated Hospital of Kunming Medical College, Kunming, China; and Jiangfan Zhong, University of Southern California, Los Angeles, CA., Su Y; Lei Gao, Yanqi Zhang, Jia Liu, Peiyan Kong, Yao Liu, Li Gao, Cheng Zhang, Lidan Zhu, Qin Wen, Ping Wang, Xinghua Chen, Jiangfan Zhong, and Xi Zhang, Third Military Medical University, Chongqing; Baoyang Hu, Chinese Academy of Sciences, Beijing; Shifeng Lou, Second Affiliated Hospital of Chongqing Medical University, Chongqing; Yi Su, General Hospital of Chengdu Military Region of People's Liberation Army, Chengdu; Tonghua Yang, Yunnan Provincial People's Hospital; Huimin Li, Affiliated Hospital of Kunming Medical College, Kunming, China; and Jiangfan Zhong, University of Southern California, Los Angeles, CA., Yang T; Lei Gao, Yanqi Zhang, Jia Liu, Peiyan Kong, Yao Liu, Li Gao, Cheng Zhang, Lidan Zhu, Qin Wen, Ping Wang, Xinghua Chen, Jiangfan Zhong, and Xi Zhang, Third Military Medical University, Chongqing; Baoyang Hu, Chinese Academy of Sciences, Beijing; Shifeng Lou, Second Affiliated Hospital of Chongqing Medical University, Chongqing; Yi Su, General Hospital of Chengdu Military Region of People's Liberation Army, Chengdu; Tonghua Yang, Yunnan Provincial People's Hospital; Huimin Li, Affiliated Hospital of Kunming Medical College, Kunming, China; and Jiangfan Zhong, University of Southern California, Los Angeles, CA., Li H; Lei Gao, Yanqi Zhang, Jia Liu, Peiyan Kong, Yao Liu, Li Gao, Cheng Zhang, Lidan Zhu, Qin Wen, Ping Wang, Xinghua Chen, Jiangfan Zhong, and Xi Zhang, Third Military Medical University, Chongqing; Baoyang Hu, Chinese Academy of Sciences, Beijing; Shifeng Lou, Second Affiliated Hospital of Chongqing Medical University, Chongqing; Yi Su, General Hospital of Chengdu Military Region of People's Liberation Army, Chengdu; Tonghua Yang, Yunnan Provincial People's Hospital; Huimin Li, Affiliated Hospital of Kunming Medical College, Kunming, China; and Jiangfan Zhong, University of Southern California, Los Angeles, CA., Liu Y; Lei Gao, Yanqi Zhang, Jia Liu, Peiyan Kong, Yao Liu, Li Gao, Cheng Zhang, Lidan Zhu, Qin Wen, Ping Wang, Xinghua Chen, Jiangfan Zhong, and Xi Zhang, Third Military Medical University, Chongqing; Baoyang Hu, Chinese Academy of Sciences, Beijing; Shifeng Lou, Second Affiliated Hospital of Chongqing Medical University, Chongqing; Yi Su, General Hospital of Chengdu Military Region of People's Liberation Army, Chengdu; Tonghua Yang, Yunnan Provincial People's Hospital; Huimin Li, Affiliated Hospital of Kunming Medical College, Kunming, China; and Jiangfan Zhong, University of Southern California, Los Angeles, CA., Zhang C; Lei Gao, Yanqi Zhang, Jia Liu, Peiyan Kong, Yao Liu, Li Gao, Cheng Zhang, Lidan Zhu, Qin Wen, Ping Wang, Xinghua Chen, Jiangfan Zhong, and Xi Zhang, Third Military Medical University, Chongqing; Baoyang Hu, Chinese Academy of Sciences, Beijing; Shifeng Lou, Second Affiliated Hospital of Chongqing Medical University, Chongqing; Yi Su, General Hospital of Chengdu Military Region of People's Liberation Army, Chengdu; Tonghua Yang, Yunnan Provincial People's Hospital; Huimin Li, Affiliated Hospital of Kunming Medical College, Kunming, China; and Jiangfan Zhong, University of Southern California, Los Angeles, CA., Gao L; Lei Gao, Yanqi Zhang, Jia Liu, Peiyan Kong, Yao Liu, Li Gao, Cheng Zhang, Lidan Zhu, Qin Wen, Ping Wang, Xinghua Chen, Jiangfan Zhong, and Xi Zhang, Third Military Medical University, Chongqing; Baoyang Hu, Chinese Academy of Sciences, Beijing; Shifeng Lou, Second Affiliated Hospital of Chongqing Medical University, Chongqing; Yi Su, General Hospital of Chengdu Military Region of People's Liberation Army, Chengdu; Tonghua Yang, Yunnan Provincial People's Hospital; Huimin Li, Affiliated Hospital of Kunming Medical College, Kunming, China; and Jiangfan Zhong, University of Southern California, Los Angeles, CA., Zhu L; Lei Gao, Yanqi Zhang, Jia Liu, Peiyan Kong, Yao Liu, Li Gao, Cheng Zhang, Lidan Zhu, Qin Wen, Ping Wang, Xinghua Chen, Jiangfan Zhong, and Xi Zhang, Third Military Medical University, Chongqing; Baoyang Hu, Chinese Academy of Sciences, Beijing; Shifeng Lou, Second Affiliated Hospital of Chongqing Medical University, Chongqing; Yi Su, General Hospital of Chengdu Military Region of People's Liberation Army, Chengdu; Tonghua Yang, Yunnan Provincial People's Hospital; Huimin Li, Affiliated Hospital of Kunming Medical College, Kunming, China; and Jiangfan Zhong, University of Southern California, Los Angeles, CA., Wen Q; Lei Gao, Yanqi Zhang, Jia Liu, Peiyan Kong, Yao Liu, Li Gao, Cheng Zhang, Lidan Zhu, Qin Wen, Ping Wang, Xinghua Chen, Jiangfan Zhong, and Xi Zhang, Third Military Medical University, Chongqing; Baoyang Hu, Chinese Academy of Sciences, Beijing; Shifeng Lou, Second Affiliated Hospital of Chongqing Medical University, Chongqing; Yi Su, General Hospital of Chengdu Military Region of People's Liberation Army, Chengdu; Tonghua Yang, Yunnan Provincial People's Hospital; Huimin Li, Affiliated Hospital of Kunming Medical College, Kunming, China; and Jiangfan Zhong, University of Southern California, Los Angeles, CA., Wang P; Lei Gao, Yanqi Zhang, Jia Liu, Peiyan Kong, Yao Liu, Li Gao, Cheng Zhang, Lidan Zhu, Qin Wen, Ping Wang, Xinghua Chen, Jiangfan Zhong, and Xi Zhang, Third Military Medical University, Chongqing; Baoyang Hu, Chinese Academy of Sciences, Beijing; Shifeng Lou, Second Affiliated Hospital of Chongqing Medical University, Chongqing; Yi Su, General Hospital of Chengdu Military Region of People's Liberation Army, Chengdu; Tonghua Yang, Yunnan Provincial People's Hospital; Huimin Li, Affiliated Hospital of Kunming Medical College, Kunming, China; and Jiangfan Zhong, University of Southern California, Los Angeles, CA., Chen X; Lei Gao, Yanqi Zhang, Jia Liu, Peiyan Kong, Yao Liu, Li Gao, Cheng Zhang, Lidan Zhu, Qin Wen, Ping Wang, Xinghua Chen, Jiangfan Zhong, and Xi Zhang, Third Military Medical University, Chongqing; Baoyang Hu, Chinese Academy of Sciences, Beijing; Shifeng Lou, Second Affiliated Hospital of Chongqing Medical University, Chongqing; Yi Su, General Hospital of Chengdu Military Region of People's Liberation Army, Chengdu; Tonghua Yang, Yunnan Provincial People's Hospital; Huimin Li, Affiliated Hospital of Kunming Medical College, Kunming, China; and Jiangfan Zhong, University of Southern California, Los Angeles, CA., Zhong J; Lei Gao, Yanqi Zhang, Jia Liu, Peiyan Kong, Yao Liu, Li Gao, Cheng Zhang, Lidan Zhu, Qin Wen, Ping Wang, Xinghua Chen, Jiangfan Zhong, and Xi Zhang, Third Military Medical University, Chongqing; Baoyang Hu, Chinese Academy of Sciences, Beijing; Shifeng Lou, Second Affiliated Hospital of Chongqing Medical University, Chongqing; Yi Su, General Hospital of Chengdu Military Region of People's Liberation Army, Chengdu; Tonghua Yang, Yunnan Provincial People's Hospital; Huimin Li, Affiliated Hospital of Kunming Medical College, Kunming, China; and Jiangfan Zhong, University of Southern California, Los Angeles, CA., Zhang X; Lei Gao, Yanqi Zhang, Jia Liu, Peiyan Kong, Yao Liu, Li Gao, Cheng Zhang, Lidan Zhu, Qin Wen, Ping Wang, Xinghua Chen, Jiangfan Zhong, and Xi Zhang, Third Military Medical University, Chongqing; Baoyang Hu, Chinese Academy of Sciences, Beijing; Shifeng Lou, Second Affiliated Hospital of Chongqing Medical University, Chongqing; Yi Su, General Hospital of Chengdu Military Region of People's Liberation Army, Chengdu; Tonghua Yang, Yunnan Provincial People's Hospital; Huimin Li, Affiliated Hospital of Kunming Medical College, Kunming, China; and Jiangfan Zhong, University of Southern California, Los Angeles, CA. zhangxxi@sina.com. |
| المصدر: | Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2016 Aug 20; Vol. 34 (24), pp. 2843-50. Date of Electronic Publication: 2016 Jul 11. |
| نوع المنشور: | Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial |
| اللغة: | English |
| بيانات الدورية: | Publisher: American Society of Clinical Oncology Country of Publication: United States NLM ID: 8309333 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1527-7755 (Electronic) Linking ISSN: 0732183X NLM ISO Abbreviation: J Clin Oncol Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2003- : Alexandria, VA : American Society of Clinical Oncology Original Publication: New York, N.Y. : Grune & Stratton, c1983- |
| مواضيع طبية MeSH: | Graft vs Host Disease/*therapy , Hematopoietic Stem Cell Transplantation/*adverse effects , Mesenchymal Stem Cell Transplantation/*methods , Mesenchymal Stem Cells/*immunology, Adolescent ; Adult ; B-Lymphocytes/immunology ; Chronic Disease ; Double-Blind Method ; Female ; Graft vs Host Disease/etiology ; Graft vs Host Disease/immunology ; HLA Antigens/genetics ; HLA Antigens/immunology ; Haploidy ; Hematopoietic Stem Cell Transplantation/methods ; Humans ; Killer Cells, Natural/immunology ; Male ; T-Lymphocytes/immunology ; Transplantation Conditioning/adverse effects ; Transplantation Conditioning/methods ; Transplantation, Homologous ; Umbilical Cord/cytology ; Young Adult |
| مستخلص: | Purpose: Although mesenchymal stromal cells (MSCs) possess immunomodulatory properties and exhibit promising efficacy against chronic graft-versus-host disease (cGVHD), little is known about the efficacy of MSCs in the prophylaxis of cGVHD after HLA-haploidentical hematopoietic stem-cell transplantation (HLA-haplo HSCT). Patients and Methods: In this multicenter, double-blind, randomized controlled trial, we investigated the incidence and severity of cGVHD among patients, and the changes in T, B, and natural killer (NK) cells after the repeated infusion of MSCs. Results: The 2-year cumulative incidence of cGVHD in the MSCs group was 27.4% (95% CI, 16.2% to 38.6%), compared with 49.0% (95% CI, 36.5% to 61.5%) in the non-MSCs control group (P = .021). Seven patients in the non-MSCs control group had severe lung cGVHD, but no patients in the MSCs group developed typical lung cGVHD (P = .047). After the MSC infusions, increasing memory B lymphocytes and regulatory T cells, as well as the ratio of type 1 T helper to type 2 T helper cells, were observed, whereas the number of NK cells decreased. Conclusion: Our findings suggest that the repeated infusion of MSCs might inhibit cGVHD symptoms in patients after HLA-haplo HSCT, accompanied by changes in the numbers and subtypes of T, B, and NK cells, leading to the acquisition of immune tolerance. (© 2016 by American Society of Clinical Oncology.) |
| التعليقات: | Comment in: J Clin Oncol. 2016 Aug 20;34(24):2812-3. (PMID: 27400943) |
| سلسلة جزيئية: | ChiCTR ChiCTR-IOR-15006330 |
| المشرفين على المادة: | 0 (HLA Antigens) |
| تواريخ الأحداث: | Date Created: 20160713 Date Completed: 20170721 Latest Revision: 20220419 |
| رمز التحديث: | 20221213 |
| DOI: | 10.1200/JCO.2015.65.3642 |
| PMID: | 27400949 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1527-7755 |
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| DOI: | 10.1200/JCO.2015.65.3642 |