ISRCTN44627941已完成1 期
Human herpes virus (HHV) specific immune effector (IE) cells for prevention and treatment of HHV-related diseases
America Yuva Biomed Inc. (China)0 个研究点目标入组 300 人开始时间: 2009年2月27日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. The participants should meet at least one of the following conditions:
- •1.1. Bone marrow transplant (BMT) or solid organ transplant (SOT) patient:
- •1.1.1. High-risk subject of lymphoproliferative disease: e.g. donor is HHV sero-positive (human herpes virus viral capsid antigen immunoglobulin G positive [HHV VCA IgG+]) and recipient is HHV sero-negative (HHV VCA IgG-) at time of transplantation
- •1.1.2. The subject has history of human herpes virus-associated lymphoproliferative disorder (HHV-LPD) or HHV-related malignancy
- •1.1.3. The subject develops HHV diseases and not considered suitable for conventional treatment
- •1.1.4. The subject shows human herpes virus deoxyribonucleic acid (HHV DNA) greater than or equal to 1000 genome copies/µg in the peripheral blood (with or without LPD) in two consecutive samplings (24 hours apart)
- •1.1.5. HHV reactivation
- •1.2. HHV-infected subjects:
- •1.2.1. Subject develops HHV LPD and not suitable for conventional treatment
- •1.2.2. The subject shows HHV DNA greater than or equal to 1000 genome copies/µg in the peripheral blood (with or without LPD) in two consecutive samplings (24 hours apart)
- •1.2.3. HHV reactivation
- •2. Aged less than or equal to 65 years, either sex
- •3. Subject blood:
- •3.1. White blood cell count (WBC) greater than or equal to 3500/µl
- •3.2. Blood lymphocytes greater than or equal to 750/µl
- •4. Liver and kidney function:
- •4.1. Creatinine less than or equal to 1.25 time of upper limit
- •4.2. Bilirubin less than or equal to 1.5 time of upper limit
- •4.3. Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 3 time of upper limit
- •4.4. Serum glutamic pyruvic transaminase (SGPT) less than or equal to 3 time of upper limit
- •5. Donor condition:
- •5.1. No chemo- or radiation-therapy within 4 weeks of blood collection; no steroid use within 1 week of blood collection
- •5.2. WBC greater than or equal to 3500/µl
- •5.3. Lymphocytes greater than or equal to 750/µl
- •6. Signed informed consent
排除标准
- •1. Donor or recipient shows hepatitis C virus (HCV), human immunodeficiency virus (HIV) or tuberculosis (TB) positive
- •2. Recipient develops grade IV graft-versus-host disease (GvHD)
- •3. Recipient is albumin-intolerant
- •4. Recipient life expectancy less than 8 weeks
- •5. Recipient received alternative cell therapy within 30 days
- •6. Recipient is pregnant
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