The Results of Pilot Study of the Mesenchymal Stem Cells Efficiency for Induction of Immunosuppressive Therapy in the Early Postoperative Period after Kidney Transplantation.
Sergey Korotkov1, Alexandr Nosik1, Alla Koritko1, Evgenia Primakova1, Margarita Dmitrieva1, Aleksei Siantovich1, Olga Yudina1, Denis Efimov1, Ivan Shturich1, Aleksei Fedoruk1, Aleksei Shcherba1, Oleg Kalachik1, Svetlana Krivenko1, Oleg Rummo1.
1Belorussian Republican Center of Organ and Tissue Transplantation, Minsk, Belarus
The aim of the study was to evaluate the efficiency of the mesenchymal stem cells (MSC) application for induction of immunosuppressive therapy (IIT) in patients after kidney transplantation (KT) in the early postoperative period.
Methods: This is a report of pilot, prospective, single center, open label, randomized study of the efficiency and safety of MSC induction of immunosupression over standard IIT in regard of immunological dysfunction development and kidney transplant function improvement. Inclusion criteria: adult kidney transplant recipients who received first kidney transplant. Exclusion criteria were high immunological risks at the time of surgery (HLA mismatching, PRA>0%). In the first group MSCs introduction was performed on 0 and 4 days after surgery in total dose of 4 million cells / kg in 2 infusions (2 million cells / kg at a time). In the second group patients received basiximab 20 mg on 0 and 4 days after transplantation. Third group hadn’t any induction therapy. Maintenance therapy includes calcineurine inhibitor, mycophenolic acid, steroids and didn’t differ among groups. The protocol kidney transplant biopsies were performed on the 7th day after surgery.
Results of our research showed that the frequency of graft dysfunction which was associated with rejection, was approximately identical among groups – 40%. At the same time the severity of acute rejection was rather low according to the results of biopsies in the MSC group. The level of serum creatinin decreased more intensively in 2nd group (baziliximab) and was assessed as 265±125 μmol/l at the 7 day after operation. In the 1st (MSC) and 3rd groups it was respectively 313±201 μmol/l and 548±317 μmol/l (р>0,05). Dynamics of GRF level restoration didn’t differ in groups and reached 31,72±10,34 ml/min, 34,7±12,4 ml/min, 35,7±11,97 ml/min respectively on 7 day after transplantation. We didn’t observe any significant difference in frequency and strength of side effects in study groups.
Conclusion: Application of allogeneic MSC as induction immunosupressive therapy in kidney transplantation is effective and safely.
