The researchers conducted a randomized trial where patients were treated with stem cells in conjunction with surgery. They discovered that these patients had a decreased incidence of acute rejection than others given anti-interleukin 2 receptor antibody induction therapy. According to lead author, Camillo Ricordi, MD, these patients also had a reduced risk of infection and saw better renal function a year following the kidney transplant.
Anti-body based induction therapy plus calineurin inhibitors is a commonly used treatment method for reducing acute rejection rates in kidney recipients. However, the researchers wrote that opportunistic infections and the toxic effects of the antibody induction therapy were challenging obstacles and novel approaches were needed.
For the study, researchers followed 159 patients at the Fuzhou General Hospital in China who had end-stage renal disease who were about to undergo a transplant from a living related donor and assigned to three random groups.
The first group consisting of 53 patients received autologous stem cells and standard doses of calcineurin inhibitors, but not interleukin 2 antibody therapy. The dosage of cells given was between 1 and 2 million per kilogram of body weight, given at kidney reperfusion and then again following 2 more weeks.
The second group of 53 patients received the same therapy, except that the calcineurin doses were reduced to 80% of standard. One patient did not survive during the follow-up procedure and was excluded from the overall analysis. Lastly, the control group of 53 patients received standard therapy with calcineurin inhibitors and interleukin 2 antibody induction, but received no stem cells. Two other patients did not survive follow-up.
Following 6 months, 11 of the 51 remaining members of the third (control) group had biopsy-confirmed acute rejection. In contrast, only 4 of the 53 patients who received stem cells and standard calcineurin inhibitors and 4 of 52 patients in the low-dose group had acute rejection.
The researchers concluded that “Although the stem cells appeared safe, extended monitoring of study participants will allow assessment of the long-term effects of autologous MSCs on renal allograft function, survival, and safety.