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

• Register: ClinicalTrials.gov
• Last refreshed on: 14 December 2015
• Main ID: NCT02382874
• Date of registration: 03/03/2015
• Prospective Registration: Yes
• Primary sponsor: Royan Institute
• Public title: Allogenic AD-MSC Transplantation in Idiopathic Nephrotic Syndrome (Focal Segmental Glomerulosclerosis)
• Scientific 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
• Date of first enrolment: May 2015
• Target sample size: 5
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02382874
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Iran, Islamic Republic of

Contacts

• Name: Nasser Aghdami, MD,PhD

• Name: Soroosh Shekarchian, MD
• Affiliation: Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.

• Name: Hassan Otukesh, MD
• Affiliation: Department Of Pediatric Nephrology and Dialysis, Ali aghar Children Hospital, Iran University of Medical Sciences, Tehran, Iran

• Name: Nasser Aghdami, MD,PhD

• Name: Rozita Hosseini, MD
• Affiliation: Department Of Pediatric Nephrology and Dialysis, Ali aghar Children Hospital, Iran University of Medical Sciences, Tehran, Iran

• Name: Nasser Aghdami, MD,PhD
• Affiliation: Head of department of regenerative medicine&cell therapy center,Royan Institute

• Name: Hamid Gourabi, PhD
• Affiliation: Head of Royan Institute

Key inclusion & exclusion 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



Age minimum: 2 Years
Age maximum: 14 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Focal Segmental Glomerulosclerosis

Intervention(s)

Biological: Intravenous injection

Primary Outcome(s)

Liver function [Time Frame: 2 weeks]

Proteinuria [Time Frame: 12 hour]

Serum creatinine [Time Frame: 2 weeks]

Secondary Outcome(s)

Increase in anti inflammatory factors [Time Frame: 12 hours]

Renal function [Time Frame: 12 hours]

Increase in Treg [Time Frame: 12hours]

Secondary ID(s)

Royan-Kidney-005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors