xml: <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/NCT06000670</url>
    </required_header>
    <id_info>
      <org_study_id>DHA</org_study_id>
      <nct_id>NCT06000670</nct_id>
    </id_info>
    <brief_title>Efficacy of Autologous Adipose Derived Stromal Vascular Fraction for Musculoskeletal Conditions</brief_title>
    <acronym>SVF</acronym>
    <official_title>Efficacy of Autologous Adipose Derived Stromal Vascular Fraction for Musculoskeletal Conditions</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dubai Health Authority</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Dubai Health Authority</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        clinical efficacy of autologous stromal vascular fraction SVF,for inflammatory and&#xD;
        degenerative conditions of the knees&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        to evaluate the clinical effectiveness of point of care autologous adipose derived stromal&#xD;
        vascular fraction (SVF) alone or in combination with exosomes,for inflammatory and&#xD;
        degenerative conditions of the knees.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">June 1, 2026</primary_completion_date>
    <phase>N/A</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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>investigator is blinded to clinical and radiological assessments .</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>change in pain level</measure>
      <time_frame>2 years</time_frame>
      <description>visual analog scale 0-10 ( 10 being worst)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>percentage cartilage thickness change</measure>
      <time_frame>2 years</time_frame>
      <description>as measured by MRI</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Knee Osteoarthritis</condition>
    <arm_group>
      <arm_group_label>knee osteoarhritis</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>patients with grade 2 and above chondromlacia as well as all grades of osteoarhtritis</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>stromal vascular fraction injection in the osteoarthritic knee</intervention_name>
      <description>stromal vascular fraction harvested from mid abdominal wall under sedation and seperated from fat using mechanical centrifugation .injection of 5 cc of the SVF in the affected knee.</description>
      <arm_group_label>knee osteoarhritis</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  knee osteoarthritis any grade&#xD;
  &#xD;
                 -  knee chondromalacia grade 2 and above&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  active HIV&#xD;
  &#xD;
            -  pregnant women&#xD;
  &#xD;
            -  Mental disease&#xD;
  &#xD;
            -  severe cardio vascular disease&#xD;
  &#xD;
            -  severe coagulation disorders&#xD;
  &#xD;
            -  infected tissues&#xD;
  &#xD;
            -  patients on other experimental studies within 3 months&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>DHA DHA</last_name>
      <role>Study Director</role>
      <affiliation>dubai health autority</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Amer Mansour, MD</last_name>
      <phone>+971502983375</phone>
      <email>dramermansour@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>mazen sawaf, MD</last_name>
      <phone>+971504545266</phone>
      <email>drmax@novomed.com</email>
    </overall_contact_backup>
    <link>
      <url>https://stemcellrevolution.com/</url>
      <description>cell surgical network</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Dubai Health Authority</investigator_affiliation>
      <investigator_full_name>Amer Mansour</investigator_full_name>
      <investigator_title>consultant orthopedic surgeon</investigator_title>
    </responsible_party>
    <keyword>knee osteoarthritis</keyword>
    <keyword>knee chondromalacia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis</mesh_term>
      <mesh_term>Osteoarthritis, Knee</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06000670
  org study id: DHA
  nct id: NCT06000670
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  clinical efficacy of autologous stromal vascular fraction SVF,for inflammatory and
        degenerative conditions of the knees
  to evaluate the clinical effectiveness of point of care autologous adipose derived stromal
        vascular fraction (SVF) alone or in combination with exosomes,for inflammatory and
        degenerative conditions of the knees.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  masking description: investigator is blinded to clinical and radiological assessments .
  measure: change in pain level
  time frame: 2 years
  description: visual analog scale 0-10 ( 10 being worst)
  measure: percentage cartilage thickness change
  time frame: 2 years
  description: as measured by MRI
  arm group label: knee osteoarhritis
  arm group type: Experimental
  description: patients with grade 2 and above chondromlacia as well as all grades of osteoarhtritis
  intervention type: Procedure
  intervention name: stromal vascular fraction injection in the osteoarthritic knee
  description: stromal vascular fraction harvested from mid abdominal wall under sedation and seperated from fat using mechanical centrifugation .injection of 5 cc of the SVF in the affected knee.
  arm group label: knee osteoarhritis
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: DHA DHA
  role: Study Director
  affiliation: dubai health autority
  last name: Amer Mansour, MD
  phone: +971502983375
  email: dramermansour@gmail.com
  last name: mazen sawaf, MD
  phone: +971504545266
  email: drmax@novomed.com
  url: https://stemcellrevolution.com/
  description: cell surgical network
  responsible party type: Principal Investigator
  investigator affiliation: Dubai Health Authority
  investigator full name: Amer Mansour
  investigator title: consultant orthopedic surgeon
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee
  sharing ipd: No