Infusion of third-party mesenchymal stem cells after renal or liver transplantation: a phase I-II, open-label, clinical study.

CHU-Ulg0 个研究点目标入组 40 人开始时间: 2011年7月5日最近更新: 2014年10月7日

试验速览

暂无简介。

•Male or female patients between 18 and 75 years of age, who will undergo first KT or whole LT from a cadaveric or DCD organ donor; fertile female patients must use a reliable contraception method;
•Informed consent given by patient or his/next of kin if the patient is unable to give informed consent, for the complete (MSC + follow-up) or partial (no MSC + follow-up) study;
•Successful liver/kidney transplantation, demonstration of organ function (improvement of INR in liver recipients and of creatinine in kidney recipients at 24-36h) and normal graft vasculature at Doppler examination.
•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 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•Past history of malignant disease, with the exception of hepatocarcinoma within the Milan criteria for the Liver Transplantation patients.
•Active uncontrolled infection.
•HIV or HCV positive.
•EBV-negative.
•Retransplantation.
•Combined transplantation.
•Living related transplantation or split liver transplantation.
•Autoimmune disease or expected impossibility to wean immunosuppression (Liver Transplantation) or corticosteroids (Kidney Transplantation).
•Endotracheal intubation.
•Postoperative cardiovascular instability, active hemorrhage, or any other serious clinical complication between transplantation and evaluation for suitability for MSC infusion.
•For Kidney Transplantation: panel reactive antibodies (PRA) >50%.

发起方

CHU-Ulg