Evaluation of Autologous Adipose Derived Mesenchymal Stromal Cells (AD-MSC) Transplantation in Ultra Filtration Failure (UFF)
Condition: Ultra Filtration Failure
Study type: Interventional
Phase: Phase 1/Phase 2

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)
    

Intervention name(s): Intravenous injection
Intervention type(s): Biological
Intervention description(s): Intravenous injection of stem cell or placebo to the patients with The patients with ultra filtration failure (UFF) .
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment