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Infusion of Third-party Mesenchymal Stem Cells After Renal or Liver Transplantation. A Phase I-II, Open-label, Clinical Study

Phase 1/Phase 2
18 Years
75 Years
Open (Enrolling)
Liver Failure, Kidney Failure

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Trial Information

Infusion of Third-party Mesenchymal Stem Cells After Renal or Liver Transplantation. A Phase I-II, Open-label, Clinical Study

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 patients undergoing kidney transplantation will be included in the
experimental arm to receive a single infusion of MSC. The outcome of each of these 2
subgroups will be compared with that of similar control patients undergoing liver or kidney
transplantation but who will not receive MSC.

Liver and kidney transplanted patients will receive standard immunosuppressive therapy,
TAC-MMF-steroïds and TAC-MMF-steroïds plus an IL-2-R antibody respectively. Patients
enrolled in the experimental arms will be infused with a single dose of 1,5-3,0 10E6 MSC/kg,
3(+/-2) days after the transplantation.

Weaning of immunosuppression will be attempted from month 6 in liver transplant patients who
did not present a rejection episode and show normal graft function and graft biopsy.

Kidney transplant patients will continue standard immunosuppressive therapy indefinitely.

Male or female (>18 years) individuals unrelated to the recipient or the graft donor will be
MSC donors. MSC donors need to fulfill generally accepted criteria for allogeneic HSC

Inclusion Criteria:

- 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)

- 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 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

- For Kidney Transplantation: panel reactive antibodies (PRA) >50%.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Infusional toxicity

Outcome Description:

Incidence, timing and severity of any clinical complication related to MSC infusion, including pulmonary events or immune reactions.

Outcome Time Frame:

Within 24 hours of infusion

Safety Issue:


Principal Investigator

Yves Beguin, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:



Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:




Start Date:

February 2012

Completion Date:

February 2017

Related Keywords:

  • Liver Failure
  • Kidney Failure
  • end-stage
  • liver diseases
  • cirrhosis
  • cancer
  • fulminant hepatic failure
  • metabolic hepatic diseases
  • congenital hepatic diseases
  • renal diseases
  • Renal Insufficiency
  • Liver Failure