EUCTR2014-003561-15-DE进行中（未招募）1 期
Safety and Tolerance of Immunomodulating Therapy with Donor-specific Mesenchymal Stem Cells in Pediatric Living-Donor Liver Transplantation - MYSTEP1
niversity Hospital of Tuebingen0 个研究点开始时间: 2015年12月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 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. Written informed consent (patients, both parents and / or legal guardian)
- •2. age = 8 weeks and = 18 years
- •3. undergoing living donor liver transplantation for chronic terminal liver failure
- •4. Body weight > 5kg
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •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. No suitability of the living-donor
- •2. Pregnant or breastfeeding
- •3. If appropriate: no use of adequate contraception
- •4. Acute liver failure; highly urgent transplantations
- •5. Receiving any form of solid organ retransplantation
- •6. Multi-Organ-Transplantations
- •7. Active autoimmune disease, e.g. autoimmune hepatitis
- •8. Pre-existing renal failure with eGFR < 50 ml/min/1.73 m2 or requiring hemodialysis
- •9. Reduced pulmonary function (children older than 6 years: FEV1 and FVC < 70% of age-appropriate norm)
- •10. History of pulmonary embolism
- •11. Pulmonary hypertension and / or right ventricular load in echocardiography
- •12. Cardiac function: left ventricular shortening fraction (FS) < 25%
- •13. Clinically significant systemic infections
- •14. Critical care treatment like mechanical ventilation, dialysis or vasopressor agents.
- •15. HIV seropositive, HTLV seropositive, Hepatitis B/C seropositive
- •16. Hepato-biliary malignancies or history of any extra-hepatic malignancy
- •17. Thrombophilia
- •18. Budd-Chiari syndrome
- •19. Pre-existent thrombosis of portal vein
- •20. Doppler-sonographic evidence for relevant porto-systemic shunts, e.g. persistent Ductus Venosus
- •21. Cold ischemia time > 90 min
- •22. Known allergy to DMSO
研究者
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