Clinical trial NCT02801890: Evaluation of Autologous Adipose Derived Mesenchymal Stromal Cells (AD-MSC) Transplantation in Ultra Filtration Failure (UFF)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ultra Filtration Failure
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2016-06-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: Systemic infection
timeFrame: 6months
measure: Hepatic failure
timeFrame: 6 months
measure: Renal failure
timeFrame: 6 months
Secondary outcomes:
measure: Ratio of 4-hour dialysate/plasma creatinine (D/P Cr).
timeFrame: 6 months
measure: Ratio of 4-hour dialysate/plasma urea (D/P urea )
timeFrame: 6 months
measure: Ratio of dialysate glucose concentrations (D/D glucose )
timeFrame: 6 months
measure: peritoneal membrane transport function
timeFrame: 6 months
measure: Glomerular filtration rate (GFR):
timeFrame: 6 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Head of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
name: Nasser Aghdami, MD,PhD
role: STUDY_DIRECTOR
affiliation: Urology Research Center, Sina Hospital, Tehran University of Medical Sciences, Iran.
name: Gholamreza Pourmand, MD
role: STUDY_DIRECTOR
affiliation: Urology Research Center, Sina Hospital, Tehran University of Medical Sciences, Iran.
name: Iraj Najafi, MD
role: STUDY_DIRECTOR
affiliation: Sudabeh
name: Sudabeh Alatab, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
name: Soroosh Shekarchian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
name: Reza Moghadasali, PhD
role: PRINCIPAL_INVESTIGATOR
References: