首页> 美国政府科技报告 >Guidance for Industry: Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System.

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Guidance for Industry: Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System.

机译：行业指南：生物制剂许可证应用于影响造血系统的疾病患者的造血和免疫重建的最小操作，无关异体胎盘/脐带血。

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年度 2014
页码 1-49
总页数 49
原文格式 PDF
正文语种 eng
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关键词
Industry guidance; Biological products; Placenta; Umbilical cord; Blood cells; Hematopoietic cells; Immunology; Licenses; Manufacturers; Patients; Statutes; Stem cells; Regulations; US FDA; Cord blood bank;

机译：行业指南;生物制品;胎盘;脐带;血细胞;造血细胞;免疫学;许可证;制造商;患者;法规;干细胞;法规;美国FDa;脐带血库;
入库时间 2022-08-29 10:48:23

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1. Transient spontaneous engraftment of CD34 hematopoietic cord blood stem cells as seen in peripheral blood: treatment of leprosy patients with anemia by placental umbilical cord whole blood transfusion. [J] . Bhattacharya N Clinical and experimental obstetrics and gynecology . 2006,第3期

机译：外周血中CD34造血干细胞的瞬时自发移植：通过胎盘脐带全血输血治疗麻风病性贫血患者。
2. Real-time qPCR for chimerism assessment in allogeneic hematopoietic stem cell transplants from unrelated adult and double umbilical cord blood [J] . Frankfurt Olga, Zitzner Jennifer R., Tambur Anat R. Human Immunology: Official Journal of the American Society for Histocompatibility and Immunogenetics . 2015,第2a3期

机译：实时定量PCR用于不相关成人和双脐血同种异体造血干细胞移植的嵌合性评估
3. Similar outcomes of allogeneic hematopoietic cell transplantation from unrelated donor and umbilical cord blood vs. sibling donor for pediatric acute myeloid leukemia: Multicenter experience in China [J] . Tang Xiangfeng, Chen Jing, Fang Jianpei, Pediatric transplantation. . 2015,第4期

机译：来自无关供体和脐带血与同胞供体的同种异体造血细胞移植治疗小儿急性髓性白血病的相似结果：中国的多中心经验
4. Immune Reconstitution after Haploidentical Donor and Umbilical Cord Blood Allogeneic Hematopoietic Cell Transplantation [O] . Hany Elmariah, Claudio G. Brunstein, Nelli Bejanyan 2021

机译：Haploidentical供体和脐带血异种造血细胞移植免疫重建
5. Reduced Intensity Allogeneic Hematopoietic Cell Transplantation in Older Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes: Comparable Outcomes With Unrelated Umbilical Cord Blood and HLA-Identical Sibling Donors [O] . Majhail N.S., Brunstein C.G., Warlick E.D., 2011

机译：老年急性粒细胞白血病和骨髓增生异常综合症的老年患者降低强度的异基因造血细胞移植：与无关脐带血和HLA同胞供者的可比结果
6. Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System. [R] . 2014

机译：工业和FDa工作人员指南：针对影响造血系统的疾病患者的造血和免疫重建的最小操作，无关异体胎盘/脐带血的研究性新药申请。

Guidance for Industry: Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System.

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