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/NCT05982054</url>
    </required_header>
    <id_info>
      <org_study_id>KM protocol</org_study_id>
      <nct_id>NCT05982054</nct_id>
    </id_info>
    <brief_title>Bone Marrow Cells With Core Decompression for AVN Treatment</brief_title>
    <official_title>Percutaneous Autologous Bone Marrow Cells With Core Decompression for Treating Avascular Hip Necrosis Under Local Anesthesia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Global Stem Cell Center, Baghdad</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Global Stem Cell Center, Baghdad</source>
    <oversight_info>
      <has_dmc>No</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>
        Avascular necrosis of the femoral head (AVN) is a progressive pathological process resulting&#xD;
        from disruption of blood supply to the femoral head and elevation of intraosseous pressure.&#xD;
        total hip arthroplasty is frequently the only durable option for pain relief and restoration&#xD;
        of function. this is a single armed study to be done from July 2023 till January 2024, the&#xD;
        total number of patients anticipated is 10, total joints treated around 20, The procedure&#xD;
        includes core decompression with autologous bone marrow derived mononuclear cell injection&#xD;
        inside the femoral head using local anesthesia ultrasound and fluoroscopy guided without&#xD;
        drilling.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Avascular necrosis of the femoral head (AVN) is a progressive pathological process resulting&#xD;
        from disruption of blood supply to the femoral head and elevation of intraosseous pressure.&#xD;
        Early stage AVN can be managed by various techniques, the results have been disappointing,&#xD;
        total hip arthroplasty is frequently the only durable option for pain relief and restoration&#xD;
        of function. This procedure is usually a high risk procedure under general anesthesia ,with&#xD;
        The newer treatment modalities include using high stem cell concentration in the vicinity of&#xD;
        the necrosed tissue with core decompression to prevent disease progression. this study is a&#xD;
        single armed study to be done from July 2023 to January 2024, the total number of patients is&#xD;
        10, Etiology include corticosteroids use, systemic lupus erythematosus mostly related to&#xD;
        steroid use in covid 19 epidemic,. The age of the patients range from 25-55 years. The&#xD;
        procedure includes core decompression with autologous bone marrow derived mononuclear cell&#xD;
        injection inside the femoral head using local anesthesia ultrasound and fluoroscopy guided&#xD;
        without drilling.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 10, 2023</start_date>
    <completion_date type="Anticipated">January 24, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 24, 2024</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>clinical improvement</measure>
      <time_frame>6 months</time_frame>
      <description>change in Harris Hip Score which include 3 parameters 1-pain, 2-range of motion,3-function. maximum 100 which is excellent while 0 is bad.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>disease progression</measure>
      <time_frame>around 6 months from starting recruitment</time_frame>
      <description>percentage of patients who have clinical progress using Harris Hip Score which include 3 parameters 1-pain, 2-range of motion,3-function. maximum 100 which is excellent while 0 is bad or radiological proof of disease progression by Mitchell classification which is used to stage osteonecrosis of the femoral head and is based on MRI signal characteristics within the center of the lesion and classified into four stages with stage A representing early disease and stage D representing late disease.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Avascular Necrosis of the Femoral Head</condition>
    <arm_group>
      <arm_group_label>bone marrow injection</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>injection of autologous concentrated bone marrow cells under ultrasound and fluoroscopy guide after core decompression</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>core decompression with local bone marrow mononuclear cells injection</intervention_name>
      <description>under local anesthesia ,anterior approach, with ultrasound and fluoroscopy guide</description>
      <arm_group_label>bone marrow injection</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Avascular hip necrosis irrespective Of stage.&#xD;
  &#xD;
            2. age from 25-55 years. -&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. history of bleeding tendency.&#xD;
  &#xD;
            2. history of malignant disease.&#xD;
  &#xD;
            3. critically ill patient. -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>abdulmajeed a hammadi, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>clinical stem cell studies</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>abdulmajeed A hammadi, MD</last_name>
      <phone>+9647902268105</phone>
      <email>majeed51578@yahoo.co.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>khalil J kareem, MD</last_name>
      <phone>+9647803977072</phone>
      <email>khaliljumakareem69@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Ministry of Health</name>
        <address>
          <city>Baghdad</city>
          <zip>964</zip>
          <country>Iraq</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>thamer M alrubaie, MD</last_name>
        <phone>+9647700009294</phone>
        <email>alzaitounhospital@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Iraq</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Global Stem Cell Center, Baghdad</investigator_affiliation>
      <investigator_full_name>abdulmajeed hammadi</investigator_full_name>
      <investigator_title>GSCCBaghdad</investigator_title>
    </responsible_party>
    <keyword>avascular necrosis of the femoral head</keyword>
    <keyword>core decompression</keyword>
    <keyword>bone marrow cells</keyword>
    <keyword>local anesthesia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Femur Head Necrosis</mesh_term>
      <mesh_term>Necrosis</mesh_term>
    </condition_browse>
    <!-- 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/NCT05982054
  org study id: KM protocol
  nct id: NCT05982054
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Avascular necrosis of the femoral head (AVN) is a progressive pathological process resulting
        from disruption of blood supply to the femoral head and elevation of intraosseous pressure.
        total hip arthroplasty is frequently the only durable option for pain relief and restoration
        of function. this is a single armed study to be done from July 2023 till January 2024, the
        total number of patients anticipated is 10, total joints treated around 20, The procedure
        includes core decompression with autologous bone marrow derived mononuclear cell injection
        inside the femoral head using local anesthesia ultrasound and fluoroscopy guided without
        drilling.
  Avascular necrosis of the femoral head (AVN) is a progressive pathological process resulting
        from disruption of blood supply to the femoral head and elevation of intraosseous pressure.
        Early stage AVN can be managed by various techniques, the results have been disappointing,
        total hip arthroplasty is frequently the only durable option for pain relief and restoration
        of function. This procedure is usually a high risk procedure under general anesthesia ,with
        The newer treatment modalities include using high stem cell concentration in the vicinity of
        the necrosed tissue with core decompression to prevent disease progression. this study is a
        single armed study to be done from July 2023 to January 2024, the total number of patients is
        10, Etiology include corticosteroids use, systemic lupus erythematosus mostly related to
        steroid use in covid 19 epidemic,. The age of the patients range from 25-55 years. The
        procedure includes core decompression with autologous bone marrow derived mononuclear cell
        injection inside the femoral head using local anesthesia ultrasound and fluoroscopy guided
        without drilling.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: clinical improvement
  time frame: 6 months
  description: change in Harris Hip Score which include 3 parameters 1-pain, 2-range of motion,3-function. maximum 100 which is excellent while 0 is bad.
  measure: disease progression
  time frame: around 6 months from starting recruitment
  description: percentage of patients who have clinical progress using Harris Hip Score which include 3 parameters 1-pain, 2-range of motion,3-function. maximum 100 which is excellent while 0 is bad or radiological proof of disease progression by Mitchell classification which is used to stage osteonecrosis of the femoral head and is based on MRI signal characteristics within the center of the lesion and classified into four stages with stage A representing early disease and stage D representing late disease.
  arm group label: bone marrow injection
  arm group type: Other
  description: injection of autologous concentrated bone marrow cells under ultrasound and fluoroscopy guide after core decompression
  intervention type: Procedure
  intervention name: core decompression with local bone marrow mononuclear cells injection
  description: under local anesthesia ,anterior approach, with ultrasound and fluoroscopy guide
  arm group label: bone marrow injection
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: 55 Years
  healthy volunteers: No
  last name: abdulmajeed a hammadi, MD
  role: Principal Investigator
  affiliation: clinical stem cell studies
  last name: abdulmajeed A hammadi, MD
  phone: +9647902268105
  email: majeed51578@yahoo.co.uk
  last name: khalil J kareem, MD
  phone: +9647803977072
  email: khaliljumakareem69@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Iraq
  responsible party type: Principal Investigator
  investigator affiliation: Global Stem Cell Center, Baghdad
  investigator full name: abdulmajeed hammadi
  investigator title: GSCCBaghdad
  mesh term: Femur Head Necrosis
  mesh term: Necrosis