Soroosh Shekarchian - Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology,Tehran, Iran
Sudabeh Alatab - Urology Department, Urology Research Center, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran
Iraj Najafi - Department of Nephrology, Nephrology Research Center, Shariati Hospital, Tehran University of Medical Sciences,Tehran, Iran
Reza Moghadasali - Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology,Tehran, Iran

Background and Aim: Following promising results of mesenchymalstem cell (MSC) transplantation in PD models in the recent decade,this method is taken into consideration in clinical trials. Experimentsreported that MSC in PD models attenuated submesothelial thickness,inflammation, angiogenesis, and fibrosis as well as improved ultrafiltrationvolume, glucose uptake, glucose mass transfer, and solutetransport. Taken together we hypothesized that MSC could induce antifibrosis,immunomodulation and anti-apoptosis effects in these settings.Therefore, we designed the first in the human clinical trial of MSC in PD.Methods: In this open-label, non-randomized, phase I clinical trial,we infused autologous adipose-derived MSC in 9 eligible patients andfollowed them for 6 months. Ten patients were regarded as the controlgroup. The primary endpoint was the safety and the secondary endpointwas the change in membrane function.Results: Fourteen minor adverse events (AE) were recorded in the MSCgroup which were subsided by itself or by supportive therapy. No seriousadverse events or adverse events related to cell infusion were recorded.There was a significant reduction in Dialysate-to-plasma ratio (D/P) ofcreatinine in the MSC group (0.77 to 0.73, P=0.02).Conclusion: In summary, this trial showed safety, feasibility, andtolerability of autologous MSC in ultrafiltration failure patients whichcould be a foundation for efficacy assessment by an RCT.

Peritoneal dialysis; Peritoneal Fibrosis; Ultrafiltration failure; Adipose tissue mesenchymal stem/stromal cell