Mesenchymal Stem Cells for Treatment of Poor Graft Function After Allogeneic Hematopoietic Stem Cell Transplant
Mesenchymal Stem Cells From Third-party Donors for Treatment of Poor Graft Function After Allogeneic Hematopoietic Stem Cell Transplantation
研究概览
详细说明
Allogeneic hematopoietic stem cell transplantation(allo-HSCT) can cure many hematologic diseases. Although good progress has been made in the prevention and treatment of side effects associated with transplantation, poor graft function (PGF) remains an important complication that occurs in 5-27% of patients, and is associated with considerable morbidity and mortality related to infections or hemorrhagic complications. Treatment of PGF usually involves the prescription of hematopoietic growth factors such as granulocyte colony-stimulating factor (G-CSF), or repeat transplantation, but these methods are associated with short-term effect and a significant risk of graft-versus-host disease(GVHD) development, respectively.
Mesenchymal stem cells (MSCs) are a form of multipotent adult stem cells that can be isolated from bone marrow (BM), adipose tissue, and cord blood. Clinical applications of human MSCs are evolving rapidly with goals of improving hematopoietic engraftment, preventing and treating graft-versus-host disease after allo-HSCT and so on. However, the efficacy of treatment of PGF that develops after allo-HSCT using expanded BM-derived MSCs from a third-party donor is rarely reported. If such treatment could be shown to be effective and safe, BM-derived MSCs could potentially be used as an universal donor material. This would have a major impact because the generation of donor-specific MSCs is time-consuming, costly, and often impractical if the clinical status of a patient is urgent.
In the present study, the investigators will prospectively evaluate the efficacy and safety of ex-vivo-expanded BM-derived MSCs from third-party donors in treating patients with PGF after allo-HSCT.
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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Guangdong
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Guangzhou、Guangdong、中国、510515
- 招聘中
- Department of Hematology,Nanfang Hospital, Southern Medical University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- A patient age of 14-65 years
- Poor graft function developing after allo-HSCT
- Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Exclusion Criteria:
- Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
- Patients with any conditions not suitable for the trial (investigators' decision)
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Mesenchymal stem cells
Mesenchymal stem cells 1×10^6 cells/kg, intravenously
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Mesenchymal stem cells will be intravenously infused via a central venous catheter,at a dose of 1×10^6 cells/kg, over 15 min.
The vital signs of all patients will be closely monitored during and for 24h after MSCs administration.
If the NEU and PLT levels do not attain the completely response(CR)standards within 14d, a second course of MSCs treatment will be given.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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造血恢复
大体时间:1年
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移植后造血重建被定义为中性粒细胞和血小板数量的重建。
中性粒细胞重建定义为前 3 天连续出现中性粒细胞 (NEU) > 0.5×10^9/L,血小板 (PLT) 重建定义为连续 3 天首次 >20×10^9/L .
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1年
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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感染、原发性基础疾病复发和 MSCs 治疗的任何毒副作用
大体时间:1年
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感染将主要集中在 MSCs 治疗后的前 100 天内。
治疗的毒副作用包括急性毒性和晚期副作用。
急性毒性主要涉及心脏、生命和肾脏。
晚期毒副作用主要涉及继发性肿瘤的发展和原发性疾病的复发。
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1年
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合作者和调查者
合作者
出版物和有用的链接
一般刊物
- Sanchez-Guijo FM, Lopez-Villar O, Lopez-Anglada L, Villaron EM, Muntion S, Diez-Campelo M, Perez-Simon JA, San Miguel JF, Caballero D, del Canizo MC. Allogeneic mesenchymal stem cell therapy for refractory cytopenias after hematopoietic stem cell transplantation. Transfusion. 2012 May;52(5):1086-91. doi: 10.1111/j.1537-2995.2011.03400.x. Epub 2011 Oct 24.
- Meuleman N, Tondreau T, Ahmad I, Kwan J, Crokaert F, Delforge A, Dorval C, Martiat P, Lewalle P, Lagneaux L, Bron D. Infusion of mesenchymal stromal cells can aid hematopoietic recovery following allogeneic hematopoietic stem cell myeloablative transplant: a pilot study. Stem Cells Dev. 2009 Nov;18(9):1247-52. doi: 10.1089/scd.2009.0029.
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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间充质干细胞的临床试验
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Rutgers, The State University of New Jersey完全的
Mesenchymal stem cells的临床试验
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Universidad de la SabanaFundación Neumologica Colombiana; Stem Medicina Regenerativa; Innocell SAS可用的
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Oregon Research Behavioral Intervention Strategies...National Institute on Minority Health and Health Disparities (NIMHD)完全的
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The First Affiliated Hospital of Soochow UniversityFundamenta Therapeutics, Ltd.招聘中
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Yan JinXijing Hospital; Tang-Du Hospital未知