NCT00361049已完成1 期
Donor Mesenchymal Stem Cell Infusion for Treatment of Graft Versus Host Disease: A Phase I Trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 16
- 主要终点
- Safety
研究概览
简要总结
RATIONALE: Donor mesenchymal stem cell infusion may be an effective treatment for acute or chronic graft-versus-host disease caused by a donor stem cell transplant.
PURPOSE: This phase I trial is studying the side effects and best dose of donor mesenchymal stem cells in treating patients with acute or chronic graft-versus-host disease after undergoing a donor stem cell transplant.
详细描述
OBJECTIVES:
Primary
- Determine the safety of donor mesenchymal stem cell (MSC) infusion in patients with acute or extensive chronic graft-vs-host disease (GVHD) after undergoing HLA-identical sibling donor stem cell transplant.
Secondary
- Describe the rates of complete and partial resolution of GVHD when MSCs are used in addition to the standard GVHD therapy.
- Determine inflammatory cytokine levels, lymphocyte subsets, and donor-reactive lymphocyte numbers in blood of patients with acute GVHD prior to therapy and at 7 and 14 days post-MSC therapy.
- Determine if donor MSCs engraft in tissues inflamed by GVHD in patients who have undergone gender-mismatched transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Safety
时间窗: Monitored for 6 hours for infusion related toxicity. Temperature, blood pressure, pulse and O2 saturation will be measured at baseline and every 10 minutes x 2, every 30 minutes x 2, and every hour x 3.
次要结局
- Complete and partial resolution of graft-vs-host disease (GVHD)(Patients will be evaluated for clinical signs and symptoms of GVHD weekly for up to 28 days.)
- Cytokine levels, lymphocyte subsets, and donor-reactive lymphocyte numbers in patients with acute GVHD(Pre-transplant, at diagnosis, 7 and 14 days after MSC infusion)
研究者
研究点 (16)
Loading locations...
相似试验
进行中（未招募）
不适用
Mesenchymal stem cell based therapy for the treatment of osteogenesis imperfectaOsteogenesis imperfecta (OI) is a rare genetic disorder with increased bone fragility of varying severity. In the majority of patients the disease is caused by mutations in collagen type I. Severe OI is characterized by osteopenia, frequent fractures, progressive deformity, short stature, loss of mobility, chronic pain and can lead to premature death. At present a cure does not exist.EUCTR2012-002553-38-ESItziar Astigarraga Aguirre
已完成
不适用
Efficacy of mesenchymal stem cells for treatment of refractory acute GVHD after stem cell transplantatiorefractoty acute GVHD after stem cell transplantationJPRN-C000000423Jichi Medical University, Department of Medicine, Division of Hematology5
已完成
1 期
Mesenchymal Stem Cells Therapy in Patients With Recent Intracerebral HemorrhageHemorrhagic StrokeIntracerebral HemorrhageNCT03371329Mayo Clinic9
Unknown
早期 1 期
Mesenchymal Stem Cell for Osteonecrosis of the Femoral HeadOsteochondritis of the Femoral HeadNCT00813267Jianming Tan15
Unknown
2 期
MSC for Treatment of cGVHD After Allo-HSCTChronic Graft-versus-host DiseaseNCT04692376Nanfang Hospital, Southern Medical University152