Allogenic AD-MSC Transplantation in Idiopathic Nephrotic Syndrome (Focal Segmental Glomerulosclerosis)
|ClinicalTrials.gov Identifier: NCT02382874|
Recruitment Status : Unknown
Verified November 2015 by Royan Institute.
Recruitment status was: Recruiting
First Posted : March 9, 2015
Last Update Posted : December 4, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Focal Segmental Glomerulosclerosis||Biological: Intravenous injection||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Allogenic Adipose Derived Mesenchymal Stromal Cells Transplantation to Improve Kidney Function in Refractory Primary Nephrotic Syndrome (Focal Segmental Glomerulosclerosis,FSGS) ,a Phase I Clinical Trial|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||October 2017|
The patients with FSGS who underwent intravenous injection of AD-MSC.
Biological: Intravenous injection
Intravenous injection of AD-MSC to the patients with FSGS
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02382874
|Contact: Nasser Aghdami, MD,PhD||(+98)21235000 ext firstname.lastname@example.org|
|Contact: Leila Arab, MD||(+98)21235000 ext 414||Leara91@gmail.com|
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of|
|Contact: Nasser Aghdami, MD,PhD (+98)2123562000 ext 516 email@example.com|
|Contact: Leila Arab, MD (+98)2123562000 ext 414 Leara91@gmail.com|
|Principal Investigator: Reza Moghadasali, PhD|
|Study Chair:||Hamid Gourabi, PhD||Head of Royan Institute|
|Study Director:||Nasser Aghdami, MD,PhD||Head of department of regenerative medicine&cell therapy center,Royan Institute|
|Study Director:||Hassan Otukesh, MD||Department Of Pediatric Nephrology and Dialysis, Ali aghar Children Hospital, Iran University of Medical Sciences, Tehran, Iran|
|Principal Investigator:||Rozita Hosseini, MD||Department Of Pediatric Nephrology and Dialysis, Ali aghar Children Hospital, Iran University of Medical Sciences, Tehran, Iran|
|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.|