EUCTR2007-004310-14-BE进行中（未招募）1 期
Infusion of mesenchymal stem cells as treatment for steroid resistant grade II to IV acute GVHD or poor graft function: a multicenter phase II study
CHU-ULG0 个研究点目标入组 120 人开始时间: 2007年12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
- 120
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
- •Patient eligibility criteria
- •1. Male or female of any age.
- •2. Previous allogeneic transplantation or autologous transplantation (for part 2 only) of HSC at any time before.
- •3. Informed consent given by donor or his/her guardian if of minor age.
- •4. Additional criteria for each part of the protocol:
- •Part 1: MSC for steroid-refractory grade II-IV acute GVHD
- •- Acute GVHD refractory to mPDN 2 mg/kg/day or equivalent
- •Part 2: MSC for poor graft function (PGF)
- •- Cytopenia in 2 or 3 lineages:
- •- Cytopenia duration = 2 weeks beyond day 28 after autologous HCT, or day 42 Part 3: MSC + DLI for poor donor T-cell chimerism
- •- Nonmyeloablative allogeneic transplantation.
- •- Donor T-cell chimerism < 50% for at least 2 consecutive weeks beyond day 21 after HCT OR = 20% decrease in donor T-cell chimerism with the second value < 50%.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. HIV positive.
- •2. Active uncontrolled infection at time of scheduled MSC infusion.
- •3. Relapsing or progressing malignancy.
研究者
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