systemic infusion of autologous adipose tissue-derived mesenchymal stem cells in peritoneal dialysis patients: feasibility and safety

Objective: using mesenchymal stem cells (mscs) is regarded as a new therapeutic approach for improving fibrotic diseases. the aim of this study to evaluate the feasibility and safety of systemic infusion of autologous adipose tissue-derived mscs (ad-mscs) in peritoneal dialysis (pd) patients with expected peritoneal fibrosis. materials and methods: this study was a prospective, open-label, non-randomized, placebo-free, phase i clinical trial. case group consisted of nine eligible renal failure patients with more than two years of history of being on pd. autologous ad-mscs were obtained through lipoaspiration and expanded under good manufacturing practice conditions. patients received 1.2 ± 0.1×10^6 cell/kg of ad-mscs via cubital vein and then were followed for six months at time points of baseline, and then 3 weeks, 6 weeks, 12 weeks, 16 weeks and 24 weeks after infusion. clinical, biochemical and peritoneal equilibration test (pet) were performed to assess the safety and probable change in peritoneal solute transport parameters. results: no serious adverse events and no catheter-related complications were found in the participants. 14 minor reported adverse events were self-limited or subsided after supportive treatment. one patient developed an episode of peritonitis and another patient experienced exit site infection, which did not appear to be related to the procedure. a significant decrease in the rate of solute transport across peritoneal membrane was detected by pet (d/p cr=0.77 vs. 0.73, p=0.02). conclusion: this study, for the first time, showed the feasibility and safety of ad-mscs in pd patients and the potentials for positive changes in solute transport. further studies with larger samples, longer follow-up, and randomized blind control groups to elucidate the most effective route, frequency and dose of mscs administration, are necessary.