<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/NCT01669746</url>
  </required_header>
  <id_info>
    <org_study_id>CA-0006931</org_study_id>
    <nct_id>NCT01669746</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate and Compare Injections of Autologous Mixed Population of Dermal Cells Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0006931)</brief_title>
  <official_title>A Multi-center, Phase 2 Study of Ji Gami(TM) CN That Evaluates the Efficacy and Safety of ex Vivo-cultured, Expanded, Occipital Autologous Dermal and Epidermal Cells, Injected Into the Hair Loss Area of the Scalp of Male and Female Subjects With Alopecia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aderans Research Institute</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aderans Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate the ability of injections of Ji Gami(TM) CN to induce hair growth in male and female&#xD;
      subjects with hair loss.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <phase>Phase 2</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in hair number</measure>
    <time_frame>24 weeks post-injection</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in hair width</measure>
    <time_frame>24 weeks post-injection</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time course of any treatment benefit</measure>
    <time_frame>24 week post-injection</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Androgenetic Alopecia</condition>
  <condition>Male Pattern Baldness</condition>
  <condition>Female Pattern Baldness</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Autologous cultured mixed population of dermal cells</intervention_name>
    <description>A piece of occipital scalp is taken from the subject. A mixed population of dermal cells from this tissue are expanded in culture. The cells are then harvested. These cells are then injected into the balding area of the scalp of the original subject.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female volunteers 18-50 years old, inclusive.&#xD;
&#xD;
          -  Women of childbearing potential must use an adequate form of contraception during&#xD;
             study participation.&#xD;
&#xD;
          -  Hair loss consistent with Grade III-Vertex, IV, or V based on the based on the&#xD;
             Norwood-Hamilton Scale providing there is bridging of hair in the anterior edge of the&#xD;
             vertex circle, or class 1 or class 2 based on the Ludwig scale.&#xD;
&#xD;
          -  Able to provide informed consent after risks and benefits of the study have been&#xD;
             explained.&#xD;
&#xD;
          -  Be willing to undergo all study procedures.&#xD;
&#xD;
          -  Ability to communicate effectively with study personnel.&#xD;
&#xD;
          -  Have no clinically significant disease or abnormal laboratory evaluations taken at the&#xD;
             screening visit.&#xD;
&#xD;
          -  Agree to abstain from use of any hair growth affecting oral or topical medication&#xD;
             including over the counter and herbal medications, minoxidil, finasteride or&#xD;
             dutasteride during the course of this study; also agrees to abstain from shaving the&#xD;
             head during the course of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are pregnant or lactating.&#xD;
&#xD;
          -  Known sensitivity to DMEM/F-12 or any component of the study material.&#xD;
&#xD;
          -  Known hypersensitivity to clindamycin hydrochloride, amphotericin B or streptomycin&#xD;
             sulfate.&#xD;
&#xD;
          -  Subjects who have used minoxidil or any oral or topical medication including over the&#xD;
             counter and herbal medications for the treatment of hair loss within 6 months of study&#xD;
             screening, or finasteride or dutasteride within 12 months of study screening.&#xD;
&#xD;
          -  A history of drug or alcohol abuse within 1 year of study enrollment.&#xD;
&#xD;
          -  Participation in any other investigational study within 30 days or six half lives of&#xD;
             its biologic activity, whichever is longer, before the scalp excision visit(s), and&#xD;
             during the time enrolled in this study.&#xD;
&#xD;
          -  Clinically significant medical or psychiatric illness currently or within 30 days of&#xD;
             study screening as determined by the investigator.&#xD;
&#xD;
          -  Clinically significant symptoms of any acute illness within 30 days prior to excision&#xD;
             day.&#xD;
&#xD;
          -  Any condition that compromises the ability to understand or comply with study&#xD;
             requirements.&#xD;
&#xD;
          -  Clinically significant abnormal laboratory parameters.&#xD;
&#xD;
          -  A positive result at screening for human immunodeficiency virus (HIV 1 or 2),&#xD;
             Hepatitis B or C, HTLV I/II.&#xD;
&#xD;
          -  Clinically significant dermatologic condition in donation or study zones.&#xD;
&#xD;
          -  Prior surgery in the donor or study zones.&#xD;
&#xD;
          -  Insufficient hair or scarring in the donor area that might impact cell growth.&#xD;
&#xD;
          -  Any disease or condition (medical or surgical) that, in the opinion of the&#xD;
             investigator, might compromise hematologic, cardiovascular, pulmonary, renal,&#xD;
             gastrointestinal, hepatic, or central nervous system function; or any condition that&#xD;
             would place the subject at increased risk.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Radiant Research, Inc.</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research, Inc.</name>
      <address>
        <city>Santa Rosa</city>
        <state>California</state>
        <zip>95405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research, Inc.</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research, Inc.</name>
      <address>
        <city>Pinellas Park</city>
        <state>Florida</state>
        <zip>33781</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research, Inc.</name>
      <address>
        <city>Akron</city>
        <state>Ohio</state>
        <zip>44311</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research, Inc.</name>
      <address>
        <city>Greer</city>
        <state>South Carolina</state>
        <zip>29650</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research, Inc.</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>August 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>July 9, 2013</last_update_submitted>
  <last_update_submitted_qc>July 9, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 11, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Androgenetic Alopecia</keyword>
  <keyword>Male Pattern Baldness</keyword>
  <keyword>Female Pattern Baldness</keyword>
  <keyword>Hair Loss</keyword>
  <keyword>Baldness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alopecia</mesh_term>
    <mesh_term>Alopecia Areata</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/NCT01669746
org study id: CA-0006931
nct id: NCT01669746
lead sponsor: 
has dmc: No
Evaluate the ability of injections of Ji Gami(TM) CN to induce hair growth in male and female
      subjects with hair loss.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from baseline in hair number
time frame: 24 weeks post-injection
measure: Change from baseline in hair width
time frame: 24 weeks post-injection
measure: Time course of any treatment benefit
time frame: 24 week post-injection
arm group label: Treatment
arm group type: Experimental
intervention type: Biological
intervention name: Autologous cultured mixed population of dermal cells
description: A piece of occipital scalp is taken from the subject. A mixed population of dermal cells from this tissue are expanded in culture. The cells are then harvested. These cells are then injected into the balding area of the scalp of the original subject.
arm group label: Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alopecia
mesh term: Alopecia Areata