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Trial record 1 of 24 for:    mesenchymal stem cells transplantation kidney
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Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Polycystic Kidney Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Royan Institute
Sponsor:
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT02166489
First received: June 14, 2014
Last updated: June 17, 2014
Last verified: November 2013
  Purpose

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 Intervention Phase
Chronic Renal Failure
Polycystic Kidney Disease
Biological: Intravenous injection autologous mesenchymal stem cells
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Royan Institute:

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


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


Estimated Enrollment: 6
Study Start Date: January 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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:

  • Pregnant or lactating
  • Basis disease such as diabetes, malignancy and autoimmune
  • Unable to follow post-operative exercise regimen or return for evaluations
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02166489

Contacts
Contact: Nasser Aghdami, MD,PhD (+98)23562000 ext 516 nasser.aghdami@royaninstitute.org
Contact: Leila Arab, MD (+98)23562000 ext 414 Leara91@gmail.com

Locations
Iran, Islamic Republic of
Royan Institute Recruiting
Tehran, Iran, Islamic Republic of
Contact: Nasser Aghdami, MD,PhD    (+98)212356000 ext 516    nasser.aghdami@royaninstitute.org   
Contact: Leila Arab, MD    (+98)23562000 ext 414    Leara91@gmail.com   
Principal Investigator: Reza Moghadasali, PhD         
Sponsors and Collaborators
Royan Institute
Investigators
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

Additional Information:
No publications provided

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT02166489     History of Changes
Other Study ID Numbers: Royan-Kidney-003
Study First Received: June 14, 2014
Last Updated: June 17, 2014
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
autologous mesenchymal stem cells
polycystic kidney disease
intravenous injection
CRF

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Multicystic Dysplastic Kidney
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Renal Insufficiency
Kidney Diseases, Cystic
Renal Insufficiency, Chronic
Congenital Abnormalities
Urogenital Abnormalities
Urologic Diseases

ClinicalTrials.gov processed this record on November 23, 2014