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

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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
Sponsor:
Information provided by (Responsible Party):
Royan Institute

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.


Condition or disease Intervention/treatment Phase
Focal Segmental Glomerulosclerosis Biological: Intravenous injection Phase 1

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: AD-MSC
The patients with FSGS who underwent intravenous injection of AD-MSC.
Biological: Intravenous injection
Intravenous injection of AD-MSC to the patients with FSGS




Primary Outcome Measures :
  1. Liver function [ Time Frame: 2 weeks ]
    increase of liver enzymes 2 weeks after cell injection.

  2. Serum creatinine [ Time Frame: 2 weeks ]
    Decrease of serum creatinine 2 weeks after cell injection.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   2 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Age 2-14 years at onset of signs or symptoms of FSGS 2- Primary FSGS involving either native kidneys or primary FSGS recurring after renal transplantation. Biopsy confirmed as primary FSGS (including all subtypes).

3-Estimated GFR ≥ 25 ml/min/1.73 m2 4- Up/c > 1.0 (g protein/g creatinine) on first am void 5- Steroid and IS resistance as defined by primary physician (patients with little or no reduction in protein excretion at 12 to 16 weeks are considered to be steroid resistant --A relapse is return of proteinuria to ≥3.5 g/day in someone who had undergone a complete or partial remission- IS resistance: no response to IS in 8-12 weeks) 6-At least one month from last immunization received has passed 7- Ability to understand and willingness to sign consent by patient legal guardian

Exclusion Criteria:

- 1- Are immunodeficient or have clinically significant chronic lymphopenia 2-Have an active infection or positive PPD test result 3-Have serologic evidence of current or past HIV, Hepatitis B, or Hepatitis C infection 4-Have any complicating medical issues that interfere with study conduct or cause increased risk such as malignancies, systemic autoimmune disease, diabetes, blood disease, liver disease, etc.

5- Positive genetic mutation testing for WT1, Podocin, Nephrin


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02382874


Contacts
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Contact: Nasser Aghdami, MD,PhD (+98)21235000 ext 516 nasser.aghdami@royaninstitute.org
Contact: Leila Arab, MD (+98)21235000 ext 414 Leara91@gmail.com

Locations
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Iran, Islamic Republic of
Royan Institute Recruiting
Tehran, Iran, Islamic Republic of
Contact: Nasser Aghdami, MD,PhD    (+98)2123562000 ext 516    nasser.aghdami@royaninstitute.org   
Contact: Leila Arab, MD    (+98)2123562000 ext 414    Leara91@gmail.com   
Principal Investigator: Reza Moghadasali, PhD         
Sponsors and Collaborators
Royan Institute
Investigators
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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.

Additional Information:
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Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT02382874     History of Changes
Other Study ID Numbers: Royan-Kidney-005
First Posted: March 9, 2015    Key Record Dates
Last Update Posted: December 4, 2015
Last Verified: November 2015

Keywords provided by Royan Institute:
Idiopathic nephrotic syndrome
adipose derived mesenchymal stromal cell
Focal segmental glomerulosclerosis

Additional relevant MeSH terms:
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Nephrotic Syndrome
Nephrosis
Glomerulosclerosis, Focal Segmental
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Nephritis