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临床试验/ISRCTN22322271
ISRCTN22322271已完成未知

A phase I/II study to investigate the safety of adenovirus-specific T-cells given to high-risk paediatric patients post allogeneic haematopoietic stem cell transplant (HSCT) to prevent or treat reactivation of adenovirus

Cell Medica Ltd (UK)0 个研究点目标入组 8 人开始时间: 2012年4月12日最近更新:

试验速览

阶段
未知
状态
已完成
发起方
入组人数
8

研究概览

简要总结

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29753677 (added 16/04/2019)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Age 16 years or younger
  • 2. Scheduled to undergo an allogeneic HSCT with an unrelated donor, mismatched unrelated donor, mismatched family donor or haplo identical donor
  • 3. The subject (or legally acceptable representative) must give informed consent (and assent for subjects = 12 years). All subjects will have a parent or guardian provide informed consent and the subject will provide witnessed verbal assent
  • 4. Negative serology for HIV 1 + 2, HepB, HepC, Syphilis, hCG.
  • Donors (for manufacturing only):
  • 1. Meets requirements of Directive 2004/23/EC as amended and the UK statutory instruments pursuant therein
  • 2. Negative serology for HIV 1 + 2, HepB, HepC, Syphilis, hCG
  • 3. Passed medical assessment for stem cell donation
  • 4. HdADV seropositive
  • 5. Signed informed consent
  • 6. Age 16 years or older

排除标准

  • 1. Pregnant or lactating females
  • 2. Co-existing medical problems that would place the patient at significant risk of death due to GVHD or its sequelae
  • 3. Human Immunodeficiency Virus (HIV) infection
  • 1. Pregnant or lactating females
  • 2. (assessed prior to apheresis) Platelets < 50x109/L

研究者

发起方
Cell Medica Ltd (UK)

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