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Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Polycystic Kidney Disease

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ClinicalTrials.gov Identifier: NCT02166489
Recruitment Status : Completed
First Posted : June 18, 2014
Last Update Posted : January 5, 2016
Sponsor:
Information provided by (Responsible Party):
Royan Institute

Study Description
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Brief Summary:
This study was designed to provide confirmation of safety of mesenchymal stem cells (MSCs) therapy in chronic renal failure due to autosomal dominant polycystic kidney disease (ADPKD).

Condition or disease Intervention/treatment Phase
Chronic Renal Failure Polycystic Kidney Disease Biological: Intravenous injection autologous mesenchymal stem cells Phase 1

Detailed Description:
The investigators will assess the 18-month safety and potential efficacy of autologous MSCs as therapy for ADPKD. A total of 6 patients with ADPKD IV injection of high doses 2×106 of autologous mesenchymal stem cells / kg their weight, which will be derived from biopsies of their bone marrow. Assessments will be made at 1, 3, 6, 12 and 18 months after cell injection. Changes in GFR rate were evaluated by scan isotope.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation the Effect of Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Autosomal Dominant Polycystic Kidney Disease
Study Start Date : March 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: mesenchymal stem cell transplantation
Intravenous injection of mesenchymal stem cell in patients with PKD
 Biological: Intravenous injection autologous mesenchymal stem cells
Intravenous injection of mesenchymal stem cell in patients with PKD


Outcome Measures
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Primary Outcome Measures :
  1. Mass formation [ Time Frame: 1 month ]
    Evaluation the probability of mass formation in patients with PKD after mesenchyma l stem cell transplantation.


Secondary Outcome Measures :
  1. Glomerular Filtration Rate (GFR) [ Time Frame: 6 months ]
    Evaluation the acceleration of Glomerular Filtration Rate (GFR) in patients after mesenchymal stem cell transplantation.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and Female
  • ADPKD symptoms
  • ADPKD confirmed with sonography and genetic testing
  • Patient's age between 18 - 60 years
  • GFR GFR 25-60 mL/min/1.73 m2
  • Ability to understand and willingness to sign consent from

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Associated Cardiovascular disease
  • Diabetes requiring medical intervention
  • Other systemic diseases involving the kidneys, such as cancer, autoimmune diseases, blood diseases, liver disease, etc.
  • Hospitalization due to illness in the last two months
  • Life expectancy of less than two years
  • Any allergies to the ingredients used in the cell culture
Contacts and Locations
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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): NCT02166489


Locations
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Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
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 of Royan Institute
Study Director: Atieh Makhlough, MD Mazandaran University of Medical Sciences, Mazandaran, Iran.
Principal Investigator: Reza Moghadasali, PhD Department of Regenerative Medicine And Royan Cell Therapy Center Royan Institute For stem Cell Biology and Technology
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT02166489    
Other Study ID Numbers: Royan-Kidney-003
First Posted: June 18, 2014    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: November 2015
Keywords provided by Royan Institute:
autologous mesenchymal stem cells
polycystic kidney disease
intravenous injection
CRF
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Polycystic Kidney Diseases
Urologic Diseases
 Kidney Diseases, Cystic
Abnormalities, Multiple
Congenital Abnormalities
Ciliopathies
Genetic Diseases, Inborn