drugset / Trial / NCT02801890

Evaluation of Autologous Adipose Derived Mesenchymal Stromal Cells (AD-MSC) Transplantation in Ultra Filtration Failure (UFF)

NCT02801890 ↗

Phase 1/2 Completed 10 enrolled Royan Institute
RandomizedParallel-groupOpen-labelTreatment

Summary

Peritoneal fibrosis may be occurred as a serious complication of peritoneal dialysis. It's the main factor of UFF that could lead to the Encapsulating Peritoneal Sclerosis (EPS). Using the potential features of MSCs in the treatment of fibrosis may offer new insights into reconstruction the damaged tissues. The project intends to transplant autologous MSCs to ten peritoneal dialysis patients with ultra-filtration failure. It's going to study infusion effects in clinical, cellular and molecular levels. So in this trial, we will evaluate the effects of this intervention after intravenous injection of autologous adipose derived mesenchymal stem cells in 10 peritoneal dialysis patients with ultra filtration failure (UFF). Fifteen UFF patients are also considered as the control group. Then they will be followed 20, 45 and 90 days, and also 4 and 6 months after first injection.

Timeline

Start
2015-08
Primary completion
2017-02
Completion
2017-03

Drugs

EvaluationDrugModalityDoseRoute
Subject AdMSC Cell therapy 1e+06 cells/kg Intravenous

Indications

No indication recorded.