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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

Tracking Information
First Submitted Date  ICMJE June 14, 2014
First Posted Date  ICMJE June 18, 2014
Last Update Posted Date January 5, 2016
Study Start Date  ICMJE March 2014
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2014)
Mass formation [ Time Frame: 1 month ]
Evaluation the probability of mass formation in patients with PKD after mesenchyma l stem cell transplantation.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02166489 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2014)
Glomerular Filtration Rate (GFR) [ Time Frame: 6 months ]
Evaluation the acceleration of Glomerular Filtration Rate (GFR) in patients after mesenchymal stem cell transplantation.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Polycystic Kidney Disease
Official Title  ICMJE Evaluation the Effect of Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Autosomal Dominant Polycystic Kidney Disease
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Renal Failure
  • Polycystic Kidney Disease
Intervention  ICMJE Biological: Intravenous injection autologous mesenchymal stem cells
Intravenous injection of mesenchymal stem cell in patients with PKD
Study Arms  ICMJE Experimental: mesenchymal stem cell transplantation
Intravenous injection of mesenchymal stem cell in patients with PKD
Intervention: Biological: Intravenous injection autologous mesenchymal stem cells
Publications * Makhlough A, Shekarchian S, Moghadasali R, Einollahi B, Hosseini SE, Jaroughi N, Bolurieh T, Baharvand H, Aghdami N. Safety and tolerability of autologous bone marrow mesenchymal stromal cells in ADPKD patients. Stem Cell Res Ther. 2017 May 23;8(1):116. doi: 10.1186/s13287-017-0557-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2014)
6
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02166489
Other Study ID Numbers  ICMJE Royan-Kidney-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Royan Institute
Study Sponsor  ICMJE Royan Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Royan Institute
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP