NCT00504803已完成2 期
Mesenchymal Stem Cell Infusion as Prevention for Graft Rejection and Graft-versus-host Disease After Allogeneic Hematopoietic Cell Transplantation With Nonmyeloablative Conditioning: a Pilot Study
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Day-100 incidence of non-relapse mortality
研究概览
简要总结
Mesenchymal Stem Cell Infusion as Prevention for Graft Rejection and Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation With Nonmyeloablative Conditioning from HLA-mismatched PBSC or cord blood: a Pilot Study
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hematological malignancies confirmed histologically and not rapidly progressing:
- •AML in CR;
- •ALL in CR;
- •CML unresponsive/intolerant to Imatinib but not in blast crisis;
- •Other myeloproliferative disorders not in blast crisis and not with extensive myelofibrosis;
- •MDS with < 5% blasts;
- •Multiple myeloma;
- •Non-Hodgkin's lymphoma (aggressive NHL should have chemosensitive disease);
- •Hodgkin's disease.
- •Clinical situations
- •Theoretical indication for a standard allo-transplant, but not feasible because:
- •Age > 55 yrs;
- •Unacceptable end organ performance;
- •Patient's refusal.
- •Indication for a standard auto-transplant: perform mini-allotransplantation 2-6 months after standard autotransplant.
- •Other inclusion criteria
- •Male or female; fertile female patients must use a reliable contraception method;
- •Age < 75 yrs.
- •Informed consent given by patient or his/her guardian if of minor age.
排除标准
- •Any condition not fulfilling inclusion criteria;
- •HIV positive;
- •Terminal organ failure, except for renal failure (dialysis acceptable);
- •Uncontrolled infection, arrhythmia or hypertension;
- •Previous radiation therapy precluding the use of 2 Gy TBI;
- •HLA-identical donor.
- •PBSC donors
- •Inclusion criteria
- •Related to the recipient (sibling, parent or child) or unrelated;
- •Male or female;
- •Weight > 15 Kg (because of leukapheresis);
- •Fulfills generally accepted criteria for allogeneic PBSC donation;
- •Informed consent given by donor or his/her guardian if of minor age, as per donor center standard procedures.
- •Exclusion criteria
- •Any condition not fulfilling inclusion criteria;
- •HIV positive;
- •Unable to undergo leukapheresis because of poor vein access or other reasons.
- •HLA matching
- •Related or unrelated donors who have 1-2 HLA mismatches, as either :
- •One antigenic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1
- •One allelic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1
- •Two allelic mismatches at HLA-A or -B or -C or -DRB1 or -DQB1
- •One antigenic mismatch + 1 allelic mismatch at HLA-A or -B or -C or -DRB1 or -DQB
- •One antigenic mismatch at -DQB1 and one other antigenic mismatch at HLA-A or -B or -C or -DRB1
- •Cord blood unit
- •Banked cord blood units will be used if they fulfill the following criteria:
- •No more than 2/6 HLA mismatches (antigenic mismatch at HLA-A or HLA-B or allelic mismatch at HLA-DRB1)
- •> 2.5 x 107 TNC/kg
- •Standard validation by FACT/Netcord criteria.
研究组 & 干预措施
1
Experimental
MSC co-infusion with either HLA-mismatched PBSC or cord blood
干预措施: Mesenchymal stem cell infusion (Procedure)
结局指标
主要结局
Day-100 incidence of non-relapse mortality
时间窗: 100 days
次要结局
- 1. Hematopoietic engraftment and graft rejection. 2. Incidence of grade II-IV and III-IV acute GVHD. 3. Immunologic reconstitution(365 days)
研究者
研究点 (1)
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