NCT02104440已完成2 期
Clinical Trial In The Treatment Of Allogeneic Post-Transplant Cytopenias With Sequential Infusion Of Allogeneic Mesenchymal Cells Expanded In Vitro
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Adverse effects at the time of infusion and infections after infusion of MSC
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of the sequential infusion of allogeneic mesenchymal stem cells (MSC), expanded "in vitro" with platelet lysate without addition of animal products in the treatment of patients undergoing allo-HSCT who developed one or more cytopenias.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hematologic malignancies who have been subjected to allo-HSCT and that are diagnosed with one or more peripheral cytopenias with complete chimerism in bone marrow (determined by molecular-STR-studies). They may include:
- •Patients who have received as a source of cells MO or SP
- •Patients who have received cells from a related donor or unrelated HLA-matched
- •Patients transplanted with myeloablative or non-myeloablative conditioning
- •Adequate cardiac function assessed from a clinical point of view by the researcher, with no history of ischemic heart disease (angina or myocardial infarction) in the previous 6 months.
- •Adequate pulmonary function assessed clinically without evidence of severe obstructive or restrictive lung disease.
- •Patients between 18 and 70 years
- •Signed informed consent
排除标准
- •Patients whose haemopathy has not been controlled by the transplantation or is in progress at the time of treatment.
- •Patients who do not have complete chimerism in bone marrow (performed within 28 days prior to baseline by molecular study -STR-).
- •Patients with thrombotic microangiopathy.
- •Patients with post-transplant cytopenias with toxic origin in relation to antiviral treatment (eg ganciclovir, valganciclovir) without concomitant graft against host disease.
- •Patients with bacterial, viral or fungal infection that is not being controlled with proper treatment.
- •Patients with a history of ischemic heart disease (angina or myocardial infarction) in the previous 6 months, and those considered by the investigator does not have adequate cardiac function, evaluated from a clinical point of view.
- •Patients with poor lung function, evaluated clinically, according to the researcher.
- •Patients who, in the opinion of the investigator, are not on a good position to tolerate treatment.
- •Patients who do not have the required donor.
- •Women pregnant or at risk of pregnancy by contraceptive measures inadequate.
- •Patients <18 or > 70 years.
- •Patients who did not sign the informed consent.
结局指标
主要结局
Adverse effects at the time of infusion and infections after infusion of MSC
时间窗: During the period of infusion of the cells into the patient (an average of one hour)
All the adverse effects that may arise and possible toxicities (WHO grade) after infusion of the cells were collected.
次要结局
- Mesenchymal cell efficiency in recovering cytopenia(Monitoring will be from the last infusion of MSCs to the patient until 90 days after the last administration)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
早期 1 期
Allogeneic CD19-targeted CAR-γδT Cell Infusion Therapy in Relapsed/Refractory B Cell Acute Lymphoblastic LeukemiaB-Cell Acute Lymphoblastic Leukemia, AdultNCT06696833The First Affiliated Hospital of Soochow University18
已完成
1 期
Treatment of Refractory Acute Graft-Versus-Host Disease by Sequential Infusion of Allogenic Mesenchymal Stem Cell.Chronic Graft-Versus-Host DiseaseNCT01956903Grupo Espanol de trasplantes hematopoyeticos y terapia celular15
已完成
2 期
Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal FracturesTibial FractureNCT02140528Royan Institute40
招募中
1 期
Safety and Efficacy of Systemic Allogenic NK Cells in R/R NeuroblastomaNeuroblastoma, Recurrent, RefractoryNeuroblastoma (NB)Neuroblastoma in ChildrenNCT06674265Marzieh Ebrahimi10
Unknown
早期 1 期
Safety and Efficacy of Allogenic Umbilical Cord Blood-derived Mesenchymal Stem Cell ProductOsteochondral Lesion of TalusNCT02338375Samsung Medical Center28