Status:
COMPLETED
Mesenchymal Stem Cells After Renal or Liver Transplantation
Lead Sponsor:
University of Liege
Conditions:
Liver Failure
Kidney Failure
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
The immune system of a patient can attack the liver or the kidney received from a donor (organ rejection). This can be prevented by treating these patients long-life with immunosuppressive drugs. Unfo...
Detailed Description
The present project aims at evaluating the safety and tolerability of third party MSC administration after liver or kidney organ transplantation. Ten patients undergoing liver transplantation and 10 p...
Eligibility Criteria
Inclusion
- Male or female patients between 18 and 75 years of age, who will undergo first Kidney Transplantation or whole Liver Transplantation from a cadaveric or donation after cardiac death (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.
Exclusion
- 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%.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01429038
Start Date
February 1 2012
End Date
March 11 2019
Last Update
June 14 2022
Active Locations (1)
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1
University Hospital Liege
Liège, Belgium, 4000