NL-OMON31471撤回2 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 - Mesenchymale stem cells versus acute GVHD
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patient eligibility criteria
- •-male or female of any age
- •-previous allogenic transplantation (related or unrelated donor, any degree of HLA matching) or autologous transplantation (for oart two only) or HSC at any time before.
- •- any source of HSC (marrow, PBSC, cord blood) and any conditioning regimen
- •- informed consent given by donor or his/her guardian if of minor age;MSC donor inclusion criteria
- •1. related to the recipent (sibling, parent or child) or unrelated
- •2. male or female
- •3. age> 16 yrs (no age limit if same as HSC donor)
- •4. no HLA matching required
- •5. fulfills generally accepted criteria for allogeneic HSC donation
- •6. informed consent given by donor or his/her guardian if of minor age;Additional criteria for each part of the protocol:
- •part 1: MSC for steroid-refractory grade II-IV acute GvHD
- •1. allogeneic transplantation
- •- grade II-IV acute GvHD refractory to mPDN 2 mg/kg/day or equivalent
- •2. ongoing therapy with ciclosporine or tacrolimus at therapeutic doses
- •3. patient may have received previously any other form of treatment for acute GvHD, but no new treatment started within 1 month of study entry;part 2: MSC for poor graft function (PGF)
- •1. allogeneic or autologous transplantation
- •- cytopenia in 2 or 3 lineages OR severe cytopenia in 1 lineage
- •2. cytopenia duration 2 weeks beyond day 28 after autologous HCT, or day 42 (day 60 for cord blood transplantation) after allogeneic HCT
- •3. cytopenia is not related to CMV or other infection, myelosuppressive/toxic drugs, renal failure, peripheral cell destruction or other identifiable cause
- •4. in case of HLA-identical related donor and full donor chimerism, patient can only be included if a boost of donor CD34+ cells has been unsuccessful or is not feasible;part 3: MSC + DLI for poor donor T-cell chimerism
- •1. allogeneic transplantation
- •2. 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%
排除标准
- •- HIV postive
- •- active uncontrolled infection at time of scheduled MSC infusion
- •- relapsing or progressing malignancy;MSC donor exclusion criteria
- •1. HIV positive
- •2. known allergy to lidocaine
- •3. if donor other than HSC donor: any risk factor for transmissible infectious diseases
研究者
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