Past Issue

Volume 20, Number 4, Jan-Mar(Winter) 2019, Serial Number: 80 Pages: 483-495

Systemic Infusion of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells in Peritoneal Dialysis Patients: Feasibility and Safety


Sudabeh Alatab, M.D., Ph.D., 1, #, Soroosh Shekarchian, M.D, 2, #, Iraj Najafi, M.D, 3, Reza Moghadasali, Ph.D, 2, 4, Naser Ahmadbeigi, Ph.D., 5, Mohammad Reza Pourmand, M.D., Ph.D., 6, Tina Bolurieh, M.Sc., 2, Neda Jaroughi, M.Sc., 2, Gholamreza Pourmand, M.D., 1, *, Nasser Aghdami, M.D., Ph.D., 2, *,
Urology Research Center, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran
Department of Regenerative Biomedicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran
Urology Research Center, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran
Department of Stem Cells and Developmental Biology, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran
Cell-based Therapies Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran
Department of Pathobiology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
*Corresponding Addresses: P.O.Box: 1136746911 Urology Research Center Sina Hospital Tehran University of Medical Sciences Tehran Iran P.O.Box: 16635-148 Department of Regenerative Biomedicine Cell Science Research Center Royan Institute for Stem Cell Biology and Technology ACECR Tehran Iran Emails:pourmand@tums.ac.ir,nasser.aghdami@royaninstitute.org

The first two authors equally contributed to this article.

Abstract

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 ± 0.1×106 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 (Registration Number: IRCT2015052415841N2).