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

NCT ID: NCT02801890

Last Updated: 2017-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2017-03-31

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)

Conditions

Ultra Filtration Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AD-MSC

The patients with ultra filtration failure (UFF) underwent AD-MSC injection.

Group Type: EXPERIMENTAL

Intravenous injection

Intervention Type: BIOLOGICAL

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

Placebo

The patients with ultra filtration failure (UFF) underwent Placebo injection.

Group Type: PLACEBO_COMPARATOR

Intravenous injection

Intervention Type: BIOLOGICAL

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

Interventions

Intravenous injection

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

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royan Institute

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hamid Gourabi, PhD

Role: STUDY_CHAIR

Head of Royan Institute

Nasser Aghdami, MD,PhD

Role: STUDY_DIRECTOR

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

Gholamreza Pourmand, MD

Role: STUDY_DIRECTOR

Urology Research Center, Sina Hospital, Tehran University of Medical Sciences, Iran.

Iraj Najafi, MD

Role: STUDY_DIRECTOR

Urology Research Center, Sina Hospital, Tehran University of Medical Sciences, Iran.

Sudabeh Alatab, MD

Role: PRINCIPAL_INVESTIGATOR

Sudabeh

Soroosh Shekarchian, MD

Role: PRINCIPAL_INVESTIGATOR

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

Reza Moghadasali, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Royan Institute

Tehran, , Iran

Countries

Iran

Other Identifiers

Royan-kidney-006

Identifier Type: -

Identifier Source: org_study_id