<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02195323</url>
  </required_header>
  <id_info>
    <org_study_id>Royan-Kidney-004</org_study_id>
    <nct_id>NCT02195323</nct_id>
  </id_info>
  <brief_title>Autologous Bone Marrow Derived Mesenchymal Stromal Cells (BM-MSCs) in Patients With Chronic Kidney Disease (CKD)</brief_title>
  <official_title>Administration of Autologous Bone Marrow Mesenchymal Stem Cells (BM-MSCs) in Patients With Chronic Kidney Disease (CKD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royan Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Royan Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was designed to provide confirmation of safety of mesenchymal stem cells (MSCs)&#xD;
      therapy in chronic kidney disease (CKD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We will assess the 18-month safety and potential efficacy of autologous MSCs as a therapy for&#xD;
      CKD. A total of 10 patients with CKD IV injection of high doses 2×106/kg of autologous MSCs&#xD;
      t, which will be derived from biopsies of their bone marrow. Assessments will be performed at&#xD;
      1, 3, 6, 12 and 18 months after cell injection. Changes in Glomerular Filtration Rate (GFR)&#xD;
      were evaluated by scan isotope.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>mass formation</measure>
    <time_frame>6months</time_frame>
    <description>Evaluation the probability of mass formation due to MSC transplantation 6 months after cell injection.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Creatinin</measure>
    <time_frame>1 month</time_frame>
    <description>Evaluation the rise of creatinin 1 month after cell transplantation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>GFR</measure>
    <time_frame>6months</time_frame>
    <description>Evaluation the increase of GFR 6 months after cell transplantation with scan isotope .</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>MSC recipient</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients with CKD who underwent intravenous injection of MSC.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Intravenous injection</intervention_name>
    <description>Intravenous injection of bone marrow derived MSC in patients with CKD.</description>
    <arm_group_label>MSC recipient</arm_group_label>
    <other_name>Intravenous transplantation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and Female&#xD;
&#xD;
          -  CKD symptoms&#xD;
&#xD;
          -  CKD confirmed with serum and urine analysis and GFR 25-60 mL/min/1.73 m2&#xD;
&#xD;
          -  Patient's age between 25 - 60 years&#xD;
&#xD;
          -  Ability to understand and willingness to sign consent from&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
&#xD;
          -  Basis disease such as diabetes, malignancy and autoimmune&#xD;
&#xD;
          -  Unable to follow post-operative exercise regimen or return for evaluations&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hamid Gourabi, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Head of Royan Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nasser Aghdami, MD,PhD</last_name>
    <role>Study Director</role>
    <affiliation>Head of regenerative medicine department &amp;cell therapy center of Royan Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Atieh Makhloogh, MD</last_name>
    <role>Study Director</role>
    <affiliation>Mazandaran University of Medical Sciences, Mazandaran, Iran</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Reza Moghadasali, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Regenerative Medicine And Royan Cell Therapy Center Royan Institute For stem Cell Biology and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royan Institute</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <link>
    <url>http://Royaninstitute.org</url>
    <description>Related Info</description>
  </link>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>January 3, 2016</last_update_submitted>
  <last_update_submitted_qc>January 3, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>autologous bone marrow mesenchymal stem cells chronic kidney disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02195323
org study id: Royan-Kidney-004
nct id: NCT02195323
lead sponsor: 
has dmc: Yes
This study was designed to provide confirmation of safety of mesenchymal stem cells (MSCs)
      therapy in chronic kidney disease (CKD).
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: mass formation
time frame: 6months
description: Evaluation the probability of mass formation due to MSC transplantation 6 months after cell injection.
measure: Creatinin
time frame: 1 month
description: Evaluation the rise of creatinin 1 month after cell transplantation.
measure: GFR
time frame: 6months
description: Evaluation the increase of GFR 6 months after cell transplantation with scan isotope .
arm group label: MSC recipient
arm group type: Experimental
description: The patients with CKD who underwent intravenous injection of MSC.
intervention type: Biological
intervention name: Intravenous injection
description: Intravenous injection of bone marrow derived MSC in patients with CKD.
arm group label: MSC recipient
other name: Intravenous transplantation
criteria: 
gender: All
minimum age: 25 Years
maximum age: 60 Years
healthy volunteers: No
last name: Hamid Gourabi, PhD
role: Study Chair
affiliation: Head of Royan Institute
last name: Nasser Aghdami, MD,PhD
role: Study Director
affiliation: Head of regenerative medicine department &cell therapy center of Royan Institute
last name: Atieh Makhloogh, MD
role: Study Director
affiliation: Mazandaran University of Medical Sciences, Mazandaran, Iran
last name: Reza Moghadasali, PhD
role: Principal Investigator
affiliation: Department of Regenerative Medicine And Royan Cell Therapy Center Royan Institute For stem Cell Biology and Technology
facility: 
country: Iran, Islamic Republic of
url: http://Royaninstitute.org
description: Related Info
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic