Clinical Trial: Allogenic AD-MSC Transplantation in Idiopathic Nephrotic Syndrome (Focal Segmental Glomerulosclerosis)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Allogenic Adipose Derived Mesenchymal Stromal Cells Transplantation to Improve Kidney Function in Refractory Primary Nephrotic Syndrome (Focal Segmental Glomerulosclerosis

Brief Summary:

Idiopathic Focal Segmental Glumero Sclerosis (FSGS) is not very common but important manifestation of kidney disease.

FSGS has poor prognosis among the patterns of Idiopathic Nephrotic Syndrome (INS).

Even with treatment (Steroid therapy and cytotoxic immunosuppressant therapy), many patients eventually still require dialysis.

Cell therapy is useful in treatment of INS and mesenchymal stromal/stem cell is one of the cells that useful in the treatment of glomerulus disease.

Intravenous injection of allogeneic adipose derived mesenchymal stromal/stem cell will be done in 5 patients with refractory INS(FSGS). They will be followed 1, 2, 4 weeks and then monthly until a year following injection day.


Detailed Summary:

Primary FSGS thought to be a part of the immune-mediated disease. Main challenge is to decrease protein excretion in urine. Only 30% of children with FSGS achieve complete remission with steroids and other 30-40% patients experience remission (partial and complete) with cytotoxic immunosuppressant drugs. Even with these treatments, many patients eventually still require dialysis. Other treatment strategy doesn't exceed beyond symptomatic treatment and delaying the progression. Also risk of recurrence after kidney transplantation is 20-50%.

Cell therapy is one of the treatment strategies and mesenchymal stromal/stem cell is one modality that notice in glomerulus disease.

We will evaluate safety and efficacy of intravenous injection of allogeneic AD-MSC (adipose-derived mesenchymal stromal cell) in 5 refractory INS patients.They will be followed 1, 2, 4 weeks and then monthly until a year following injection day.


Sponsor: Royan Institute

Current Primary Outcome:

  • Liver function [ Time Frame: 2 weeks ]
    increase of liver enzymes 2 weeks after cell injection.
  • Serum creatinine [ Time Frame: 2 weeks ]
    Decrease of serum creatinine 2 weeks after cell injection.
  • Proteinuria [ Time Frame: 12 hour ]
    Reduction in proteinuria to <200 to 300 mg/day will be assessed by Changes in 24 hour urine protein analysis.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Renal function [ Time Frame: 12 hours ]
    will be assessed by change in serum levels of Cr, Urea and GFR. Time Frame: 12 hr after injection,1,2 weeks then monthly until a year after 1st injection.
  • Increase in anti inflammatory factors [ Time Frame: 12 hours ]
    It will be assessed by change in serum levels of IL-2, 10. Time frame: 12 hour after injection then monthly until a year 1st injection.
  • Increase in Treg [ Time Frame: 12hours ]
    It will be assessed by change in serum levels of Treg. Time frame: 12 hr after injection,1 week, 3, 6,12 months after 1st injection.


Original Secondary Outcome: Same as current

Information By: Royan Institute

Dates:
Date Received: March 3, 2015
Date Started: May 2015
Date Completion: October 2017
Last Updated: December 3, 2015
Last Verified: November 2015