EUCTR2011-000176-33-IT进行中（未招募）不适用
Cell Therapy Of Duchenne Muscular Dystrophy by intra-arterial delivery of HLA-identical allogeneic mesoangioblasts - ND
FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR0 个研究点开始时间: 2011年2月23日最近更新:
适应症
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
- Male
入选标准
- •1. Age between 6 and 14 years at time of study entry. 2. Completion of clinical trial DMD01 (Outcome measures validation study for children affected by Duchenne Muscular Dystrophy”). 3. Availability of HLA identical donor MABS previously collected in good number and quality as specified in a separate clinical protocol (DMD02). 4. Written informed consent of caregivers of DMD patients and patient’s assent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Positive hepatitis B surface antigen, hepatitis C antibody test, or human immunodeficiency virus (HIV) test. 2. Presence of immune deficiency, neoplastic or autoimmune disease (based on clinical history). 3. Bleeding disorder. 4. Any known allergies to products likely to be used in the study. 5. Prior or ongoing medical condition (e.g. concomitant illness, psychiatric condition, behavioural disorder, drug abuse), medical history, physical findings, or laboratory abnormality that, in the investigator’s opinion, could adversely affect the safety of the subject, makes it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of study results. 6. Ongoing participation in any other therapeutic clinical trial (use of steroids will be considered standard care and therefore permitted). 7. If abnormal heart US: LVEF (ventricular left ventricular ejection fraction) < 45% or ECG finding significant for underlying cardiac impairment. 8. Pulmonary function tests assessed by spirometry (if cooperative) of FEV1 and FVC <50% of the predicted values. If non cooperative, pulse oximetry < 95 % in room air. 9. Change of medication related to DMD within last 3 months with the exception of adjustment based on weight gain of current medications. 10. Presence of severe scoliosis (curve >100?). 11. Presence of significant impairment of renal or hepatic function defined as serum creatinine =1.5 ? upper limit of normal (ULN), serum bilirubin =1.5 ? ULN.
研究者
相似试验
已完成
2 期
Treatment of Duchenne Muscular Dystrophy with Cyclosporine AG71.0Muscular dystrophyDRKS00000445niversitätsklinikum FreiburgZentrum für Kinder- und Jugendmedizin150
招募中
不适用
Problemas de nutrição em meninos que tem a fraqueza muscular conhecida como distrofia muscular de duchenne.Muscular dystrophyduchenne muscular dystrophy.G71.0C05.651.534.500.300RBR-7cfdxmDepartamento de Nutrição
进行中（未招募）
1 期
Immunsuppressive Therapy in Duchenne Muscular Dystrophy - DMD-CsADuchenne Muscular DystrophyEUCTR2005-000663-26-ATniversitätsklinik Freiburg150
进行中（未招募）
1 期
Restoring Dystrophin Expression in Duchenne Muscular Dystrophy: A Phase I/II Clinical Trial Using AVI-4658Duchenne Muscular DystrophyEUCTR2006-003833-33-GBImperial College, London9
已完成
2 期
utriceuticals in Duchenne muscular dystrophyNeurological - Other neurological disordersHuman Genetics and Inherited Disorders - Other human genetics and inherited disordersMusculoskeletal - Other muscular and skeletal disordersDuchenne muscular dystrophyACTRN12610000462088The Royal Children's Hospital48