A Phase I/II Trial in Treating Patients With Graft-Versus-Host Disease by the Infusion of Expanded in-Vitro Allogenic Mesenchymal Stem Cell
试验速览
- 阶段
- 1 期
- 入组人数
- 15
- 试验地点
- 8
- 主要终点
- Determine the safety/efficacy of expanded in-vitro allogenic mesenchymal stem cell infusion in patients developing a GVHD refractory to the usual therapeutic measures after undergoing an allogeneic hematopoietic stem cell transplant.
研究概览
简要总结
Clinical trial based on the use of a new therapeutic strategy (MSC infusion) for the treatment of patients who have developed a GVHD refractory to the usual therapeutic measures after undergoing an allogenic hematopoietic stem cell transplant.
详细描述
This is a multicenter, single dose study of allogenic mesenchymal stem cell (1-2 x 10^6 MSC/Kg recipient´s bodyweight).
MSC will be infused, by a central venous catheter, to patients diagnosed with GVHD refractory to first-line or subsequent treatment.
All patients will receive the same treatment. MSC suspension will be obtained from the bone marrow aspiration of a family donor and expanded in-vitro in a specific culture medium with autologous donor´s serum and with no animal-derived products.
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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hematological malignancies who had been undergone an allogenic hematopoietic stem cell transplant and diagnosed with GVHD refractory to a usual treatment.
- •Adequate cardiac function with no evidence of uncontrolled high blood pressure,congestive heart failure, angina pectoris, acute myocardial infarction within 6 months prior to the process.
- •Adequate pulmonary function with no evidence of chronic obstructive or severe restrictive pulmonary disease.
- •Patients with ages between 18 and 65 years.
- •Signature of informed consent form is required to be done by patient and donor.
排除标准
- •Patients whose hematopathology has not been controlled by the transplant or is in progress.
- •Patients with bacterial, viral or fungal infection not being controlled with the adequate treatment.
- •Patients with an inadequate cardiac or pulmonary function.
- •Patients who, in the investigator´s point of view, are not in situation to tolerate the treatment.
- •Patients who do not have the required donor (HLA-identical sibling donor and not HLA-identical sibling donor).
- •Pregnant females or childbearing potential who are not on adequate contraceptive measures.
- •Patients <18 or >65 years.
- •Patients who do not sign the informed consent.
结局指标
主要结局
Determine the safety/efficacy of expanded in-vitro allogenic mesenchymal stem cell infusion in patients developing a GVHD refractory to the usual therapeutic measures after undergoing an allogeneic hematopoietic stem cell transplant.
Efficacy will be evaluated in terms of GVHD response.
Safety will be evaluated in terms of incidence of adverse events and toxicities related to the administration of MSC.
次要结局
- Evaluation of infectious complications after MSC infusion.
- Analyse the influence of MSC infusion on the posttransplant relapse risk of the base disease.
- Study the influence of MSC infusion on DFS and OS.
- Determine MSC grafted into the bone marrow (or in other organs).