SuO012PHASE I CLINICAL TRIAL OF ADMINISTRATION OF ADIPOSE-DERIVED MESENCHYMAL STEM CELLS IN PERITONEAL DIALYSIS PATIENTS

Abstract

INTRODUCTION AND AIMS: Chronic kidney disease is considered to be an uprising public health issue. CKD may progress to end‐stage renal failure which requires renal replacement therapy (RRT). These modalities include kidney transplant, hemodialysis or peritoneal dialysis (PD). PD is characterized by a continuous removal of extracellular fluid through peritoneal membrane. Chronic PD might be complicated by ultra‐filtration failure (UFF), which is a functional abnormality of peritoneal membrane. UFF is known to be a risk factor for developing Encapsulating Peritoneal Sclerosis (EPS). Considering the potential of mesenchymal stem cells (MSCs) in treatment of fibrosis, we aimed to assess the feasibility and safety of MSCs infusion in PD patients with probable peritoneal fibrosis. METHODS: In this open label, non‐randomized, phase I clinical trial, we intended to infuse autologous adipose derived MSCs (AD‐MSCs) in ten peritoneal dialysis patients with ultra‐filtration failure. We evaluated safety and tolerability of MSC infusion. The trial registry code is IRCT2015052415841N2 Nine eligible PD patients who had documented UFF, enrolled to the trial and received 1.260.1∗106 cell/kg of AD‐MSCs intravenously. Fifteen PD patients were also considered as the control group. All the patients were followed for 6 months. Safety was the primary endpoint which was assessed by the number and severity of adverse events (AE), and hematological and biochemical assessment following cell infusion. Secondary endpoint was probable change in peritoneal solute transport parameters measured by Peritoneal Equilibration Test (PET). RESULTS: All patients completed follow up visits. We indicated no serious adverse events and no AEs related to cell infusion. 14 AEs were recorded which resolved following palliative care.We detected an episode of peritonitis in one patient (5th month) and one exit site infection (1st month) which were probably not related to the procedure, because of long time gap between procedure and observed complications. None of the hematological and biochemical parameters significantly changed over time. There was a significant decrease in rate of solute transport across peritoneal membrane measured by PET (D/P Cr=0.77 vs 0.73, P=0.02). CONCLUSIONS: To best of our knowledge, this is the first trial which showed safety and tolerability of a single dose infusion of autologousAD‐MSCs in PD patients. The efficacy of the AD‐MSC infusion should be tested by further randomized double blind control trials.