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/NCT06042140</url>
    </required_header>
    <id_info>
      <org_study_id>HSC-MS-23-0584</org_study_id>
      <nct_id>NCT06042140</nct_id>
    </id_info>
    <brief_title>Cryopreserved Human Umbilical Cord as a Meningeal Patch in Fetoscopic Spina Bifida Repair</brief_title>
    <acronym>HUC-FICS</acronym>
    <official_title>Cryopreserved Human Umbilical Cord as a Meningeal Patch in Fetoscopic Spina Bifida Repair: Single Arm Phase III Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The University of Texas Health Science Center, Houston</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The University of Texas Health Science Center, Houston</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The objective is to test the efficacy of a laparotomy-assisted fetoscopic surgical approach&#xD;
        to cover spina bifida spinal cord developmental defects using cryopreserved human umbilical&#xD;
        cords (NEOX Cord 1K®) as a meningeal and skin patch.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 8, 2023</start_date>
    <completion_date type="Anticipated">September 8, 2036</completion_date>
    <primary_completion_date type="Anticipated">March 8, 2031</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>Number of participants that can ambulate independently by walking at least 10 steps</measure>
      <time_frame>30-36 months after delivery</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of participants with lower extremity motor and sensory levels exceeding the anatomical level of the lesion by ≥ 2 segments</measure>
      <time_frame>30-36 months after delivery</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Spina Bifida; Fetus</condition>
    <condition>Myelomeningocele</condition>
    <condition>Myeloschisis</condition>
    <arm_group>
      <arm_group_label>NEOX Cord 1K applied fetoscopically</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients intending to undergo open in-utero spina bifida repair will be offered to be screened for an alternative minimally invasive approach. All eligible pregnant mothers' fetuses within the trial will receive NEOX Cord 1K® as a spinal cord cover to close the developmental defect. In some cases, at the discretion of the Pediatric Neurosurgeon, NEOX Cord 1K® may be required to cover the skin. All eligible subjects meeting all inclusion criteria but none of the exclusion criteria may be enrolled.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>NEOX Cord 1K applied fetoscopically</intervention_name>
      <description>Under general anesthesia and tocolysis, in-utero repair begins with a laparotomy that is followed by exteriorization of the uterus. The fetus is then positioned by external cephalic version. Uterine entry will be accessed using 3 cannulas, followed by heated-humidified carbon dioxide insufflation for visualization. Then, fetoscopically the placode will be examined and dissected. The lesion will be repaired using NEOX Cord 1K® (HUC) for closure of the first layer over the neural placode. Primary closure of the skin will then occur, or NEOX Cord 1K® (human umbilical cord) will be used for skin closure at the discretion of the Pediatric Neurosurgeon. Finally, the laparotomy site will be sutured in multiple layers.</description>
      <arm_group_label>NEOX Cord 1K applied fetoscopically</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Maternal Inclusion Criteria:&#xD;
  &#xD;
            1. Singleton pregnancy&#xD;
  &#xD;
            2. Gestational age at screening is 19 to 25 5/7 weeks and gestational age at surgery is&#xD;
               22 to 25 6/7 weeks&#xD;
  &#xD;
            3. Maternal age: 18 years and older&#xD;
  &#xD;
            4. Body mass index ≤45 kg/m2 (pre-pregnancy)&#xD;
  &#xD;
            5. No preterm birth risk factors (short cervix &lt;20 mm or a history of previous preterm&#xD;
               delivery)&#xD;
  &#xD;
            6. No previous uterine incision in the active uterine segment&#xD;
  &#xD;
            7. Willing to undergo an open fetal repair if the fetoscopic approach is unsuccessful&#xD;
  &#xD;
          Fetal Inclusion Criteria:&#xD;
  &#xD;
            1. Spina bifida defect between T1 to S1 vertebral levels&#xD;
  &#xD;
            2. Chiari II malformation&#xD;
  &#xD;
            3. No evidence of kyphosis (curved spine)&#xD;
  &#xD;
            4. No major life-threatening fetal anomaly unrelated to spina bifida&#xD;
  &#xD;
            5. Normal karyotype, or a normal chromosomal microarray analysis (CMA), or a CMA with&#xD;
               variants of unknown significance [fluorescence in situ hybridization (FISH) acceptable&#xD;
               if ≥ 24 weeks].&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Maternal Exclusion Criteria:&#xD;
  &#xD;
            1. Non-resident of the United States&#xD;
  &#xD;
            2. Multifetal pregnancy&#xD;
  &#xD;
            3. Poorly controlled insulin-dependent pregestational diabetes&#xD;
  &#xD;
            4. Poorly controlled A2 diabetes mellitus (A2DM) insulin-dependent diabetes&#xD;
  &#xD;
            5. Current or planned cerclage or documented history of an incompetent cervix&#xD;
  &#xD;
            6. Placenta previa or placental abruption&#xD;
  &#xD;
            7. Short cervix of &lt; 20 mm&#xD;
  &#xD;
            8. Obesity as defined by a body mass index of &gt; 45 kg/m2&#xD;
  &#xD;
            9. Previous spontaneous singleton delivery prior to 37 weeks&#xD;
  &#xD;
           10. Maternal-fetal Rh isoimmunization, Kell sensitization, or a history of neonatal&#xD;
               alloimmune thrombocytopenia&#xD;
  &#xD;
           11. HIV or Hepatitis-B positive status&#xD;
  &#xD;
           12. Known Hepatitis-C positivity&#xD;
  &#xD;
           13. Uterine anomaly such as large or multiple fibroids or a mullerian duct abnormality&#xD;
               that is diagnosed via imaging prior to surgery, which that are unavoidable during&#xD;
               surgery&#xD;
  &#xD;
           14. Other medical conditions which are contraindication to surgery or general anesthesia&#xD;
  &#xD;
           15. Patient does not have a support person&#xD;
  &#xD;
           16. Inability to comply with the travel and follow-up requirements of the trial&#xD;
  &#xD;
           17. Patient does not meet psychosocial standardized assessment criteria&#xD;
  &#xD;
           18. Participation in this or another intervention study that influences maternal and fetal&#xD;
               morbidity and mortality&#xD;
  &#xD;
           19. Maternal hypertension&#xD;
  &#xD;
           20. Zika virus positivity&#xD;
  &#xD;
           21. Allergy/history of drug reaction to Amphotericin B&#xD;
  &#xD;
          Fetal exclusion criteria:&#xD;
  &#xD;
            1. Major fetal anomaly not related to spina bifida&#xD;
  &#xD;
            2. Kyphosis in the fetus of 30 degrees or more&#xD;
  &#xD;
            3. Ventriculomegaly greater than 15 mm and no movements noted at hip and knee joints&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ramesha Papanna, MD, MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>The University of Texas Health Science Center, Houston</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ramesha Papanna, MD, MPH</last_name>
      <phone>(713) 500-6423</phone>
      <email>Ramesha.Papanna@uth.tmc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jeannine Garnett, PhD</last_name>
      <phone>(713) 486-6557</phone>
      <email>Jeannine.Garnett@uth.tmc.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The University of Texas Health Science Center at Houston</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77030</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ramesha Papanna, MD, MPH</last_name>
        <phone>713-500-6423</phone>
        <email>Ramesha.Papanna@uth.tmc.edu</email>
      </contact>
      <contact_backup>
        <last_name>Jeannine Garnett, PhD</last_name>
        <phone>(713) 486-6557</phone>
        <email>Jeannine.Garnett@uth.tmc.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Ramesha Papanna, MD, MPH</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
      <investigator_full_name>Ramesha Papanna</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Fetoscopic fetal intervention</keyword>
    <keyword>Human umbilical cord</keyword>
    <keyword>NEOX Cord 1K</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spinal Dysraphism</mesh_term>
      <mesh_term>Meningomyelocele</mesh_term>
      <mesh_term>Spina Bifida Cystica</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/NCT06042140
  org study id: HSC-MS-23-0584
  nct id: NCT06042140
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  The objective is to test the efficacy of a laparotomy-assisted fetoscopic surgical approach
        to cover spina bifida spinal cord developmental defects using cryopreserved human umbilical
        cords (NEOX Cord 1K®) as a meningeal and skin patch.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of participants that can ambulate independently by walking at least 10 steps
  time frame: 30-36 months after delivery
  measure: Number of participants with lower extremity motor and sensory levels exceeding the anatomical level of the lesion by ≥ 2 segments
  time frame: 30-36 months after delivery
  arm group label: NEOX Cord 1K applied fetoscopically
  arm group type: Experimental
  description: Patients intending to undergo open in-utero spina bifida repair will be offered to be screened for an alternative minimally invasive approach. All eligible pregnant mothers' fetuses within the trial will receive NEOX Cord 1K® as a spinal cord cover to close the developmental defect. In some cases, at the discretion of the Pediatric Neurosurgeon, NEOX Cord 1K® may be required to cover the skin. All eligible subjects meeting all inclusion criteria but none of the exclusion criteria may be enrolled.
  intervention type: Device
  intervention name: NEOX Cord 1K applied fetoscopically
  description: Under general anesthesia and tocolysis, in-utero repair begins with a laparotomy that is followed by exteriorization of the uterus. The fetus is then positioned by external cephalic version. Uterine entry will be accessed using 3 cannulas, followed by heated-humidified carbon dioxide insufflation for visualization. Then, fetoscopically the placode will be examined and dissected. The lesion will be repaired using NEOX Cord 1K® (HUC) for closure of the first layer over the neural placode. Primary closure of the skin will then occur, or NEOX Cord 1K® (human umbilical cord) will be used for skin closure at the discretion of the Pediatric Neurosurgeon. Finally, the laparotomy site will be sutured in multiple layers.
  arm group label: NEOX Cord 1K applied fetoscopically
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ramesha Papanna, MD, MPH
  role: Principal Investigator
  affiliation: The University of Texas Health Science Center, Houston
  last name: Ramesha Papanna, MD, MPH
  phone: (713) 500-6423
  email: Ramesha.Papanna@uth.tmc.edu
  last name: Jeannine Garnett, PhD
  phone: (713) 486-6557
  email: Jeannine.Garnett@uth.tmc.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: The University of Texas Health Science Center, Houston
  investigator full name: Ramesha Papanna
  investigator title: Professor
  mesh term: Spinal Dysraphism
  mesh term: Meningomyelocele
  mesh term: Spina Bifida Cystica
  sharing ipd: No