Injection of mesenchymal stem cells to prevent organ rejection after liver or kidney transplantation.

Conditions: iver failure: end-stage liver diseases, including cirrhosis, primary liver cancer, fulminant hepatic failure and numerous other metabolic or congenital hepatic diseases. Kidney failure: end-stage renal diseases.
MedDRA version: 14.0Level: LLTClassification code 10050434Term: Prophylaxis against liver transplant rejectionSystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.0Level: LLTClassification code 10050436Term: Prophylaxis against renal transplant rejectionSystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2011-001822-81-BE

Lead Sponsor: CHU-Ulg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 40

Inclusion Criteria

Patients
•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

Exclusion Criteria

•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%.