EUCTR2006-004420-37-ES进行中（未招募）不适用
Estudio de Fase III, Aleatorio, Doble Ciego, Controlado con Placebo para Evaluar la Eficacia y Seguridad de la Infusión de Prochymal® (Células Madre Mesenquimales Adultas Humanas, Cultivadas Ex-vivo) para el Tratamiento de la EICH (GVHD) Aguda Refractaria a los Esteroides
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
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
- •Subjects must be 6 months to 60 years of age, inclusive
- •Subjects who were diagnosed with acute GVHD before day 100 post transplant
- •Subjects must have Grade II-IV acute GVHD subsequent to allogeneic HSCT or donor leukocyte infusion that has failed to respond to corticosteroid therapy
- •Subjects must be able to begin Prochymal™ infusion within 3 days of determination of steroid refractory disease.
- •Subjects must have adequate renal function as defined by:
- •Calculated Creatinine Clearance of >30mL/min using the Cockroft Gault equation
- •Subjects who are women of childbearing potential, must be non-pregnant, not breast-feeding, and use adequate contraception. Male subjects must use adequate contraception.
- •Subject must have a minimum Karnofsky Performance Level of at least 30 at the time of study entry.
- •Subject (or legal representative where appropriate) must be capable of providing written informed consent.
- •Are the trial subjects under 18? yes
- •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
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subject has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would interfere with the evaluation of the subject (e.g., infection, heart failure, pulmonary hypertension, etc.).
- •Subjects may not receive any other investigational agents to treat acute GVHD concurrently during study participation.
- •Subject has a known allergy to bovine or porcine products.
- •Subjects who are not expected to survive at least four weeks (eg, due to ongoing, active infections or other comorbidities).
研究者
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