EUCTR2013-000534-35-ES进行中（未招募）不适用
Phase II clinical trial in the treatment of cytopenias allogeneic post-transplant with a sequential infusion of allogeneic mesenchymal cells expanded in vitro.
Fundación Castellano Leonesa de Hematología y Hemoterapia (FUCALHH)0 个研究点开始时间: 2013年4月9日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients with hematologic malignancies who have undergone allo-HSCT and are diagnosed with one or more cytopenias peripheral with full chimerism in bone marrow. They may be included:
- •a. Patients who have received BM or PS as cell source
- •b. Patients who have received cells from a family donor or HLA-matched unrelated
- •c. Patients transplanted with myeloablative or nonmyeloablative conditioning.
- •2. Patients must have adequate cardiac function without evidence of uncontrolled hypertension, congestive heart failure, angina pectoris or myocardial infarction within 6 months prior to the process.
- •3. Adequate pulmonary function with no evidence of obstructive or restrictive pulmonary disease severe.
- •4. Patients between 18 and 70 years
- •5. Signature of informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •1. Patients whose blood disease has not been controlled by the transplantation or is in progress at the time of treatment.
- •2. Patients who do not have full chimerism in bone marrow
- •3. Patients with bacterial, viral or fungal infection that is not being controlled with proper treatment.
- •4. Patients with poor cardiac function and / or pulmonary
- •5. Patients that on investigator judgment are not in a good position to tolerate treatment
- •6. Patients who do not have the required donor.
- •7. Pregnant women or with risk of pregnancy due to inadequate contraceptive measures.
- •8. Patients <18 or> 70 years.
- •9. Patients who do not sign the consent form.
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