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临床试验/NCT02083731
NCT02083731Unknown2 期

Mesenchymal Stem Cells for Treatment of CMV Infection After Hematopoietic Stem Cell Transplant

Nanfang Hospital, Southern Medical University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
2 期
入组人数
120
试验地点
1
主要终点
Percentage of Participants achieved complete remission of CMV infection

研究概览

简要总结

The purpose of this study is to evaluate the efficacy of mesenchymal stem cells (MSC) in the treatment of refractory cytomegalovirus (CMV) infection after allogeneic hematopoietic stem cell transplantation (allo-HSCT).

详细描述

Viral infections are common complications after allo-HSCT. With wide use of HLA-mismatch, unrelated and cord blood donors as alternative sources of hematopoietic stem cells, and anti-thymocyte globulin (ATG) as the standard prophylaxis of graft versus host disease (GVHD) in HLA-mismatch and unrelated donor transplantation, allo-HSCT recipients are at increasing risk for viral infections.

Till now, CMV remains one of the most important viruses and causes of death in the recipients of allo-HSCT. Approximately 75% of CMV-seropositive recipients develop CMV reactivation, and 20-30% of these patients develop CMV disease without intervention. Ganciclovir is the first-line treatment of CMV diseases. However, bone marrow suppression, which is the main and common side effect, limits the utility of ganciclovir in allo-HSCT recipients. Besides, ganciclovir and other antiviral agents resistance has been reported up to 28%. Since it has been known that specific immune response to CMV is important to control reactivation, CMV-specific CTL has been used in prophylaxis and treatment of CMV viremia in several studies. However, the production of CTL requires time. Mesenchymal stem cells (MSC) are a form of multipotent adult stem cells that can be isolated from bone marrow (BM), adipose tissue, and cord blood. In vivo experiment showed that MSCs have antimicrobial activity.

In this trial, we will use MSCs in the recipients with refractory CMV infections.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
14 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A patient age of 14-65 years
  • Refractory CMV infection or CMV-associated diseases
  • 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

排除标准

  • 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)

结局指标

主要结局

Percentage of Participants achieved complete remission of CMV infection

时间窗: 1 year

次要结局

  • Number of Participants with Serious and Non-Serious Adverse Events(up to 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Qifa Liu

Professor

Nanfang Hospital, Southern Medical University

研究点 (1)

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