MedTrace Logo

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

NCT02801890 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-04-27

No results posted yet for this study

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.

Conditions

  • Ultra Filtration Failure

Interventions

BIOLOGICAL

Intravenous injection

Intravenous injection of stem cell or placebo to the patients with The patients with ultra filtration failure (UFF) .

Sponsors & Collaborators

  • Royan Institute

    lead OTHER_GOV

Principal Investigators

  • Hamid Gourabi, PhD · Head of Royan Institute

  • Nasser Aghdami, MD,PhD · Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.

  • Gholamreza Pourmand, MD · Urology Research Center, Sina Hospital, Tehran University of Medical Sciences, Iran.

  • Iraj Najafi, MD · Urology Research Center, Sina Hospital, Tehran University of Medical Sciences, Iran.

  • Sudabeh Alatab, MD · Sudabeh

  • Soroosh Shekarchian, MD · Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.

  • Reza Moghadasali, PhD · Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-02-28
Completion
2017-03-31

Countries

  • Iran

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02801890 on ClinicalTrials.gov