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
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence, timing and severity of any clinical complication related to MSC infusion, including pulmonary events or immune reactions.
Within 24 hours of infusion
Yves Beguin, MD, PhD
Belgium: Federal Agency for Medicinal Products and Health Products