EUCTR2005-001925-27-GB进行中（未招募）1 期
Phase I/II clinical trial of T cell suicide gene therapy following haploidentical stem cell transplantation
Great Ormond Street Hospital For Children NHS Trust0 个研究点目标入组 10 人开始时间: 2009年6月10日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patients with primary immunodeficiencies or haematological malignancies at GOSH (children aged upto 16 years) undergoing haplo identical transplant
- •2.Both patient and donor must give informed consent in writing.
- •3.The donor must be willing, able and available for donation of T cells by collection of whole blood or leucapheresis.
- •4.The patient should be free of serious intercurrent illness.
- •5.Female patients of child-bearing age must have a negative pregnancy test, and agree to use reliable contraceptive methods for the duration of the therapy.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Donor unfit or unavailable
- •2.Donor positive for hepatitis b or c, or htlv-1, or hiv
- •3.Patient receiving Ganciclovir, Aciclovir, Cidofovir a result of active CMV, varicella zoster, adenovirus or herpes simplex infection infection
- •4.gvhd > grade ii before infusion of gm-t cells
- •5.serious intercurrent illness
- •6.Positive pregnancy test or reluctance to use contraception
研究者
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