Liver 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: 14.0 Level: LLT Classification code 10050434 Term: Prophylaxis against liver transplant rejection System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.0 Level: LLT Classification code 10050436 Term: Prophylaxis against renal transplant r
Conditions
Sponsors
CHU-Ulg
Eligibility
Sex/Gender
All
Inclusion criteria
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
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%.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of MSC infusion after liver and kidney transplantation. ;Secondary Objective: 1.To evaluate patient and graft survivals. 2.To evaluate the effects of MSC on graft function (for LT: bilirubin, INR, transaminases, GGT; for KT: number of post transplant hemodialysis, creatinine). 3.To evaluate biopsy-proven (Banff classification) rejection rates. 4.To evaluate the feasibility and safety of weaning or decreasing immunosuppression. 5.To evaluate recipient’s immune function (T cell blood populations (including T regs) by FACS, TREC quantification, Vß repertoire diversity, pathogen-specific T cells, anti-organ donor HLA antibodies). 6.To evaluate the potential development of anti-MSC donor HLA antibodies.;Primary end point(s): To evaluate the safety of MSC infusion after liver and kidney transplantation: 1. infusional toxicity. 2. incidence of infections (bacterial, viral, fungal, parasitic) and cancers (PTLD).;Timepoint(s) of evaluation of this end point: Continuously for 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.To evaluate patient and graft survivals. 2.To evaluate the effects of MSC on graft function. 3.To evaluate biopsy-proven (Banff classification) rejection rates. 4.To evaluate the feasibility and safety of weaning or decreasing immunosuppression; 5.To evaluate recipient’s immune function (T cell blood populations (including T regs) by FACS, TREC quantification, Vß repertoire diversity, pathogen-specific T cells, anti-organ donor HLA antibodies). 6.To evaluate the potential development of anti-MSC donor HLA antibodies.;Timepoint(s) of evaluation of this end point: 1.Patient and graft survivals; continuously for 2 years 2.Effects of MSC on graft function: LT: bilirubin, INR, transaminases, GGT, at day 7, months 1, 3, 6, 9, 12. KT: number of post transplant hemodialysis, creatinine at day 7, months 1, 3, 6, 9, 12. 3.Biopsy-proven (Banff classification) rejection rates at months 3, 6, 9, 12. 4.Feasibility and safety of weaning or decreasing immunosuppression; continuously for 2 years 5.To evaluate recipient’s immune function (T cell blood populations (including T regs) by FACS, TREC quantification, Vß repertoire diversity, pathogen-specific T cells, anti-organ donor HLA antibodies) at months 1, 2, 3, 4, 6, 9, 12; 6.Potential development of anti-MSC donor HLA antibodies at months 1, 3, 6, 12. | — |
Countries
Belgium
Outcome results
None listed