Induction Therapy with Autologous Mesenchymal Stem Cells in Living-related Kidney Transplants: A Randomized Controlled Trial.
Tan J, Wu W, et al.JAMA, 307(11): 1169-1177, 2012.
Aims
To compare the risk and benefit profile of autologous mesenchymal stem cells infusion with anti–interleukin-2 receptor antibody induction therapy in living-related donor kidney transplants.
Interventions
Autologous mesenchymal stem cells plus standard-dose calcineurin inhibitors (CNIs) versus autologous mesenchymal stem cells plus low-dose CNIs versus anti–interleukin-2 receptor antibodies plus standard-dose CNIs. All patients received mycophenolate mofetil and corticosteroids.
Participants
159 living donor kidney transplant recipients.
Outcomes
The primary outcome was the incidence of biopsy-confirmed acute rejection and estimated glomerular filtration rate (GFR) within the first year. The secondary outcomes were 1-year patient and graft survival and the incidence of opportunistic infections. Safety assessment included incidence of adverse events, vital signs, laboratory parameters (hematology, clinical chemistry, and urine analyses), infections, surgical wound healing and formation of lymphoceles.
Follow-up
1 year
CET Conclusions
The infusion of autologous mesenchymal stem cells at the time of transplantation and two weeks after transplantation resulted in a lower incidence of acute rejection, an apparent decrease in the risk of opportunistic infection and a better estimated GFR at one year in both groups receiving the stem cell infusion, in one arm with standard CNIs therapy and in the other with low dose CNIs therapy in contrast to the controls treated with standard CNIs therapy and induced with an anti–interleukin-2 receptor antibody. These are quite intriguing results in this well conducted trial and deserve further investigation.
Data analysis
Available case analysis
Trial registration
NCT00658073 (ClinicalTrials.gov)