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Autologous Bone Marrow Derived Mesenchymal Stromal Cells (BM-MSCs) in Patients With Chronic Kidney Disease (CKD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02195323
Recruitment Status : Completed
First Posted : July 21, 2014
Last Update Posted : January 5, 2016
Information provided by (Responsible Party):
Royan Institute

Brief Summary:
This study was designed to provide confirmation of safety of mesenchymal stem cells (MSCs) therapy in chronic kidney disease (CKD).

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Biological: Intravenous injection Phase 1

Detailed Description:
We will assess the 18-month safety and potential efficacy of autologous MSCs as a therapy for CKD. A total of 10 patients with CKD IV injection of high doses 2×106/kg of autologous MSCs t, which will be derived from biopsies of their bone marrow. Assessments will be performed at 1, 3, 6, 12 and 18 months after cell injection. Changes in Glomerular Filtration Rate (GFR) were evaluated by scan isotope.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Administration of Autologous Bone Marrow Mesenchymal Stem Cells (BM-MSCs) in Patients With Chronic Kidney Disease (CKD)
Study Start Date : April 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: MSC recipient
The patients with CKD who underwent intravenous injection of MSC.
Biological: Intravenous injection
Intravenous injection of bone marrow derived MSC in patients with CKD.
Other Name: Intravenous transplantation

Primary Outcome Measures :
  1. mass formation [ Time Frame: 6months ]
    Evaluation the probability of mass formation due to MSC transplantation 6 months after cell injection.

  2. Creatinin [ Time Frame: 1 month ]
    Evaluation the rise of creatinin 1 month after cell transplantation.

Secondary Outcome Measures :
  1. GFR [ Time Frame: 6months ]
    Evaluation the increase of GFR 6 months after cell transplantation with scan isotope .

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and Female
  • CKD symptoms
  • CKD confirmed with serum and urine analysis and GFR 25-60 mL/min/1.73 m2
  • Patient's age between 25 - 60 years
  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02195323

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Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
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Study Chair: Hamid Gourabi, PhD Head of Royan Institute
Study Director: Nasser Aghdami, MD,PhD Head of regenerative medicine department &cell therapy center of Royan Institute
Study Director: Atieh Makhloogh, 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

Additional Information:
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Responsible Party: Royan Institute Identifier: NCT02195323    
Other Study ID Numbers: Royan-Kidney-004
First Posted: July 21, 2014    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: November 2015
Keywords provided by Royan Institute:
autologous bone marrow mesenchymal stem cells chronic kidney disease
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency