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

Autologous AD-MSC Transplantation in Peritoneal Dialysis Patients With Ultra Filtration Failure and Evaluation of Cellular and Molecular Effects of Mesenchymal Stem Cell Infusion on Peritoneal Fibrosis

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.

Study Overview

• Status: Completed
• Conditions: Ultra Filtration Failure
• Intervention / Treatment: Biological: Intravenous injection

Detailed Description

Chronic kidney disease is defined as a reduced glomerular filtration rate, increased urinary albumin excretion, or both, and is an increasing public health issue. Prevalence is estimated to be 8-16% worldwide. Stage 5 CKD is often called end-stage kidney disease and usually means that the patient requires renal replacement therapy (RRT), which may involve a kidney transplant or a form of dialysis. One of the options in RRT is continuous ambulatory peritoneal dialysis (CAPD). CAPD is characterized by a continuous removal of extracellular fluid by peritoneal membrane. It should be noted that like any other peritoneal dialysis therapy, CAPD has Short or long-term complications and UFF is the most common functional disorder in which the peritoneal ultrafiltration membrane damaged.

This project intends to evaluate, the role of autologous mesenchymal stem cells in improvement of peritoneal membrane function in peritoneal dialysis patients who have ultrafiltration failure up to 6 months.

In this study, 10 male and female subjects who are on peritoneal dialysis for at least two years and have ultrafiltration failure with age range of 18 to 70 years will be enrolled. Patients will be selected from peritoneal dialysis patients attending the peritoneal dialysis ward of Dr. Shariati hospital. The main inclusion criteria is to be on peritoneal dialysis for at least last two years and having Ultrafiltration failure. After obtaining the consent form, a sample of fat tissue will be obtained by a general surgeon under sterilized condition from patients and then in the specialized lab, the mesenchymal stem cells will be separated and cultured to reach appropriate numbers (106/kg). The cells will be injected through peripheral vein in hospital setting. Patients will be followed-up (clinically and laboratory) at baseline and at week 3, week 6, month 3, month 4 and month 6. The clinical assessment and peritoneal function tests will be performed in each visit. Outcome measures: The main outcome measures that periodically will be assessed include: D/P cr, D/P urea, D0/D glucose, PET, KT/V urea, Glomerular filtration rate (GFR)

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Royan Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. peritoneal dialysis for at least last two years and
2. Ultrafiltration failure
3. Both genders
4. Age 18-70 years
5. inform consent signing

Exclusion Criteria:

1. Inability of patients to attend visits and regular testing
2. Estimated lifetime less than one year
3. Use of immunosuppressive drugs
4. Pregnancy
5. Malignancy
6. Coagulative disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AD-MSC; The patients with ultra filtration failure (UFF) underwent AD-MSC injection.	Biological: Intravenous injection; Intravenous injection of stem cell or placebo to the patients with The patients with ultra filtration failure (UFF) .
Placebo Comparator: Placebo; The patients with ultra filtration failure (UFF) underwent Placebo injection.	Biological: Intravenous injection; Intravenous injection of stem cell or placebo to the patients with The patients with ultra filtration failure (UFF) .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systemic infection	Evaluation the rate of systemic infection in patients with UFF after cell therapy.	6months
Hepatic failure	Evaluation the rate of hepatic failure in patients with UFF after cell therapy.	6 months
Renal failure	Evaluation the rate of renal failure in patients with UFF after cell therapy.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratio of 4-hour dialysate/plasma creatinine (D/P Cr).	Evaluation the change of (D/P Cr) in patients with UFF after cell therapy.	6 months
Ratio of 4-hour dialysate/plasma urea (D/P urea )	Evaluation the change of D/P in patients with UFF after cell therapy.	6 months
Ratio of dialysate glucose concentrations (D/D glucose )	Evaluation the change of D/D glucose in patients with UFF after cell therapy.	6 months
peritoneal membrane transport function	Assessment of peritoneal membrane transport function by peritoneal equilibration test (PET)	6 months
Glomerular filtration rate (GFR):	Evaluation the change of Glomerular filtration rate (GFR) in patients with UFF after cell therapy.	6 months

Collaborators and Investigators

• Sponsor: Royan Institute
• Investigators: Principal Investigator: Soroosh Shekarchian, MD, Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.; Study Director: 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.; Study Director: Gholamreza Pourmand, MD, Urology Research Center, Sina Hospital, Tehran University of Medical Sciences, Iran.; Study Director: Iraj Najafi, MD, Urology Research Center, Sina Hospital, Tehran University of Medical Sciences, Iran.; Principal Investigator: Sudabeh Alatab, MD, Sudabeh; Principal Investigator: 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 record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: June 12, 2016
• First Submitted That Met QC Criteria: June 12, 2016
• First Posted (Estimate): June 16, 2016

Study Record Updates

• Last Update Posted (Actual): April 27, 2017
• Last Update Submitted That Met QC Criteria: April 26, 2017
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: Royan-kidney-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO