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

Phase 1

Completed

• Conditions: Ultra Filtration Failure
• Interventions: Biological: Intravenous injection

• Registration Number: NCT02801890
• Lead Sponsor: Royan Institute

Brief 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.

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 Timeline

• Study Start: 2015-08
• Study First Submitted: 2016-06-12
• Study First Submitted QC: 2016-06-12
• Study First Posted: 2016-06-16
• Status Verified: 2016-12
• Primary Completion: 2017-02
• Study Completion: 2017-03
• Last Update Submitted: 2017-04-26
• Last Update Posted: 2017-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AD-MSC	Intravenous injection	The patients with ultra filtration failure (UFF) underwent AD-MSC injection.
Placebo	Intravenous injection	The patients with ultra filtration failure (UFF) underwent Placebo injection.

Primary Outcome Measures

Name	Time	Method
Systemic infection	6months	Evaluation the rate of systemic infection in patients with UFF after cell therapy.
Hepatic failure	6 months	Evaluation the rate of hepatic failure in patients with UFF after cell therapy.
Renal failure	6 months	Evaluation the rate of renal failure in patients with UFF after cell therapy.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Royan Institute; 🇮🇷 Tehran, Iran, Islamic Republic of