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临床试验/NCT02274662
NCT02274662已完成4 期

Expanded Access Protocol Thymus Transplantation for Immunodeficiency, Hematologic Malignancies, and Autoimmune Disease Related to Poor Thymic Function

Sumitomo Pharma Switzerland GmbH0 个研究点目标入组 11 人开始时间: 2014年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
11
主要终点
Survival Rate at End of 1 Year

研究概览

简要总结

The primary purpose is to provide access for patients who have immunodeficiency or severe autoimmune disease related to poor thymic function to cultured thymus tissue for implantation. With no thymus function, bone marrow stem cells do not develop into educated T cells, which fight infection.

Eligible participants receive cultured thymus tissue for implantation and may undergo biopsy. Immune suppression may be given depending on the immune status and clinical condition of the participant. Immune function testing is continued for one year post-implantation.

详细描述

The patients enrolled have a high likelihood of death if they do not receive culture thymus tissue because of lack of thymus function. As there are many types of patients who may be enrolled, study results will not have statistical significance.

The study objective is to make cultured thymus tissue available for implantation on an expanded access basis. Data will be collected on survival, naïve T cell development, T cell chimerism, and implant related toxicities, as well as any unexpected study-related serious adverse events.

Eligible subjects receive cultured thymus tissue and may undergo allograft biopsy. Immune suppression may be given depending on the subject's immune status and clinical condition.

Protocol specified studies continue until approximately one year post-implantation. Study participation lasts approximately two years.

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

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Cultured thymus tissue implantation (CTTI)

Experimental

Cultured thymus tissue for the treatment of immunodeficiency and autoimmune disorders

干预措施: Cultured Thymus Tissue (Biological)

Cultured thymus tissue implantation (CTTI)

Experimental

Cultured thymus tissue for the treatment of immunodeficiency and autoimmune disorders

干预措施: Blood Draw (Procedure)

Cultured thymus tissue implantation (CTTI)

Experimental

Cultured thymus tissue for the treatment of immunodeficiency and autoimmune disorders

干预措施: Rabbit Anti-Thymocyte Globulin and Cyclosporine or Tacrolimus (Drug)

结局指标

主要结局

Survival Rate at End of 1 Year

时间窗: 1 Year

Survival Rate at End of 2 Year

时间窗: 2 Year

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

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Expanded Access Protocol Thymus Transplantation | 临床试验