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Trial record 92 of 497 for:    stem cell kidney

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

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ClinicalTrials.gov Identifier: NCT02801890
Recruitment Status : Completed
First Posted : June 16, 2016
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Ultra Filtration Failure Biological: Intravenous injection Phase 1 Phase 2

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  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : March 2017

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) .




Primary Outcome Measures :
  1. Systemic infection [ Time Frame: 6months ]
    Evaluation the rate of systemic infection in patients with UFF after cell therapy.

  2. Hepatic failure [ Time Frame: 6 months ]
    Evaluation the rate of hepatic failure in patients with UFF after cell therapy.

  3. Renal failure [ Time Frame: 6 months ]
    Evaluation the rate of renal failure in patients with UFF after cell therapy.


Secondary Outcome Measures :
  1. Ratio of 4-hour dialysate/plasma creatinine (D/P Cr). [ Time Frame: 6 months ]
    Evaluation the change of (D/P Cr) in patients with UFF after cell therapy.

  2. Ratio of 4-hour dialysate/plasma urea (D/P urea ) [ Time Frame: 6 months ]
    Evaluation the change of D/P in patients with UFF after cell therapy.

  3. Ratio of dialysate glucose concentrations (D/D glucose ) [ Time Frame: 6 months ]
    Evaluation the change of D/D glucose in patients with UFF after cell therapy.

  4. peritoneal membrane transport function [ Time Frame: 6 months ]
    Assessment of peritoneal membrane transport function by peritoneal equilibration test (PET)

  5. Glomerular filtration rate (GFR): [ Time Frame: 6 months ]
    Evaluation the change of Glomerular filtration rate (GFR) in patients with UFF after cell therapy.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801890


Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
Study Chair: Hamid Gourabi, PhD Head of Royan Institute
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: Soroosh Shekarchian, MD Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
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.

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT02801890     History of Changes
Other Study ID Numbers: Royan-kidney-006
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No