Allogenic AD-MSC Transplantation in Idiopathic Nephrotic Syndrome (Focal Segmental Glomerulosclerosis)
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
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2015
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2015
CompletedFirst Posted
Study publicly available on registry
March 9, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedDecember 4, 2015
November 1, 2015
2.1 years
March 3, 2015
December 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Liver function
increase of liver enzymes 2 weeks after cell injection.
2 weeks
Serum creatinine
Decrease of serum creatinine 2 weeks after cell injection.
2 weeks
Proteinuria
Reduction in proteinuria to \<200 to 300 mg/day will be assessed by Changes in 24 hour urine protein analysis.
12 hour
Secondary Outcomes (3)
Renal function
12 hours
Increase in anti inflammatory factors
12 hours
Increase in Treg
12hours
Study Arms (1)
AD-MSC
EXPERIMENTALThe patients with FSGS who underwent intravenous injection of AD-MSC.
Interventions
Eligibility Criteria
You may qualify if:
- \- 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).
- 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
You may not qualify if:
- \- 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.
- Positive genetic mutation testing for WT1, Podocin, Nephrin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royan Institutelead
Study Sites (1)
Royan Institute
Tehran, Iran
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2015
First Posted
March 9, 2015
Study Start
May 1, 2015
Primary Completion
June 1, 2017
Study Completion
October 1, 2017
Last Updated
December 4, 2015
Record last verified: 2015-11