mbilical cord blood transplantation in high-risk hematological patients using stemregenin-1 expanded hematopoietic stem cells.A feasibility study focussing on engraftment and hematopoietic recovery. - Cord Blood Expansion (SR-1)

Erasmus MC0 个研究点开始时间: 2016年9月12日最近更新: 2016年10月31日

适应症

试验速览

暂无简介。

•- Age 18-70 years inclusive
•- Diagnosis of poor-risk hematological malignancy or (V)SAA relapsing after or failing immunosuppressive therapy and meeting the criteria for a MUD allo SCT
•- Lacking a sufficiently matched volunteer unrelated donor or lacking such a donor within the required time period of = 2 months in case of urgently needed alloSCT
•- Availability of 1 (=5/6) matched UCB graft with a nuclear cell count > 2,7 x 107/kg (see paragraph 8.2).
•- Availability of an back-up autograft, harvested and frozen earlier in the course of treatment, (harvest according to local aphersis policies)
•- WHO performance status 0-2
•- Written 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 9
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1

•Bilirubin and/or transaminases > 2.5 x normal value
•Creatinine clearance < 40 ml/min
•Cardiac dysfunction as defined by:
•-Reduced left ventricular function with an ejection fraction < 45% as measured by MUGA scan or echocardiogram (another method for measuring cardiac function is acceptable)
•- Unstable angina
•- Unstable cardiac arrhythmias
•Pulmonary function test with VC, FEV1 and/ or DCO < 50%
•Active, uncontrolled infection
•History of high dose (= 8 Gy) total body irradiation
•Pregnant or lactating females
•HIV positivity

发起方