<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/NCT04467671</url>
  </required_header>
  <id_info>
    <org_study_id>IDE18703</org_study_id>
    <secondary_id>1UG3HL148693</secondary_id>
    <secondary_id>1UH3HL148693</secondary_id>
    <nct_id>NCT04467671</nct_id>
  </id_info>
  <brief_title>Two-Year Study of the Safety and Efficacy of the Second-Generation Tissue Engineered Vascular Grafts</brief_title>
  <acronym>TEVG-2</acronym>
  <official_title>Prospective, Open-labeled, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of the Second-generation Tissue Engineered Vascular Graft as Vascular Conduits for Extracardiac Total Cavopulmonary Connection.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nationwide Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Gunze Limited</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Nationwide Children's Hospital</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>
      A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG&#xD;
      as vascular conduits for extracardiac total cavopulmonary connection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This investigation is a prospective, open-labeled clinical trial determining the safety of&#xD;
      the use of tissue engineered vascular grafts as conduits for EC TCPC. Patients will be&#xD;
      monitored for adverse events (AE) and serious adverse events (SAE). Special attention will be&#xD;
      paid to the incidence of stenosis. We will determine graft-related morbidity and mortality&#xD;
      for the second generation TEVGs which will include any post-operative complication such as&#xD;
      any aneurismal dilation, stenosis, thromboembolic or infectious event that requires treatment&#xD;
      and is thought to be caused by the graft as determined by the investigators and confirmed by&#xD;
      the data safety monitoring board. The graft related complication rates will be compared&#xD;
      between the first and second generation TEVGs. An interim analysis will be performed to&#xD;
      assess the incidence of early (&lt;6 month) graft-related complications in the first 6 enrolled&#xD;
      patients. Safety and tolerability will be assessed through serial imaging, to determine the&#xD;
      effect of growth and remodeling on graft performance through echocardiography and&#xD;
      4-dimensional MRI. All appropriate patients requiring EC TCPC who meet study&#xD;
      inclusion/exclusion criteria will be evaluated for enrollment in the clinical trial. All&#xD;
      enrolled subjects will be required to have follow-up visits at Nationwide Children's Hospital&#xD;
      for a minimum of 2 years following implant. After obtaining informed consent for the&#xD;
      patient's parents, patients with single ventricle cardiac anomalies will undergo EC TCPC&#xD;
      using a tissue engineered conduit. Post-operative care and monitoring will follow an&#xD;
      established, standardized, clinical algorithm in which the patient's clinical status&#xD;
      including complications and measurements of graft function will be serially evaluated and&#xD;
      recorded over a two year period using physical examination, echocardiography, and MRI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Anticipated">August 2027</completion_date>
  <primary_completion_date type="Anticipated">August 2025</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and Tolerability of TEVG</measure>
    <time_frame>2 years</time_frame>
    <description>Assessed through graft related complications as determined by serial echocardiogram</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety and Tolerability of TEVG</measure>
    <time_frame>2 years</time_frame>
    <description>Assessed through graft related complications as determined by serial MRI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety and Tolerability of TEVG</measure>
    <time_frame>2 years</time_frame>
    <description>Assessed through adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy of TEVG</measure>
    <time_frame>2 years</time_frame>
    <description>Evaluate graft performance based on MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of TEVG</measure>
    <time_frame>2 years</time_frame>
    <description>Measured graft volume(mL) as determined by MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of TEVG</measure>
    <time_frame>2 years</time_frame>
    <description>Measured graft length (mm) as determined by MRI</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>HLH - Hypoplastic Left Heart Syndrome</condition>
  <condition>DORV</condition>
  <condition>DILV - Double Inlet Left Ventricle</condition>
  <condition>Mitral Atresia</condition>
  <condition>Tricuspid Atresia</condition>
  <condition>Unbalanced AV Canal</condition>
  <condition>Single-ventricle</condition>
  <condition>Heart Defects, Congenital</condition>
  <condition>Cardiovascular Abnormalities</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Heart Diseases</condition>
  <arm_group>
    <arm_group_label>Tissue Engineered Vascular Grafts</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Tissue Engineered Vascular Grafts</intervention_name>
    <description>Patients will undergo EC TCPC interposition grafting with a tissue engineered vascular graft and serial magnetic resonance imaging (MRI)</description>
    <arm_group_label>Tissue Engineered Vascular Grafts</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients will be eligible for inclusion in the study if they meet all of the following&#xD;
             criteria.&#xD;
&#xD;
               1. Patient must be a candidate to undergo an extracardiac total cavopulmonary&#xD;
                  connection.&#xD;
&#xD;
               2. Patient and/or legal guardian must voluntarily provide informed consent/assent&#xD;
                  for participation in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients will be excluded from participation in the study if they meet any of the&#xD;
             following criteria.&#xD;
&#xD;
               1. Patient has an urgent/emergent operative status.&#xD;
&#xD;
               2. Patient has acute renal failure or renal insufficiency in the opinion of the&#xD;
                  investigator&#xD;
&#xD;
               3. Patient requires a graft less than 12 mm or greater than 24 mm in diameter.&#xD;
&#xD;
               4. Patient has a pacemaker.&#xD;
&#xD;
               5. Patient has pulmonary vascular resistance greater than 4 um2 (u=Wood's units)&#xD;
&#xD;
               6. Patient has abnormal venous drainage (interrupted inferior vena cava [IVC]).&#xD;
&#xD;
               7. Patient presents with significant atrio-ventricular valve regurgitation that in&#xD;
                  the opinion of the investigator, makes them ineligible.&#xD;
&#xD;
               8. Patient has a history of another condition or significant medical problem that,&#xD;
                  in the opinion of the investigator, precludes compliance with protocol-specified&#xD;
                  procedures.&#xD;
&#xD;
               9. Patients taking any medications that in the opinion of the Investigator could&#xD;
                  interfere with the TEVG, including bisphosphonates (i.e. Clodronate or&#xD;
                  Zoledronate).&#xD;
&#xD;
              10. Patient or parent/legal guardian is, in the opinion of the investigator, unable&#xD;
                  to comply with protocol evaluations.&#xD;
&#xD;
              11. Preoperative hemoglobin &lt;11.0 mg/dL at time of patient's pre-admission testing.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christopher Breuer, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Nationwide Children's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Toshiharu Shinoka, MD/PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Nationwide Children's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mark Galantowicz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nationwide Children's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Samantha Fichtner, BSN, RN</last_name>
    <phone>614-355-5764</phone>
    <email>samantha.fichtner@nationwidechildrens.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Joanne Chisolm, MSN, RN</last_name>
    <email>joanne.chisolm@nationwidechildrens.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Samantha Fichtner, BSN, RN</last_name>
      <phone>614-355-5764</phone>
      <email>samantha.fichtner@nationwidechildrens.org</email>
    </contact>
    <contact_backup>
      <last_name>Joanne Chisolm, MSN, RN</last_name>
      <email>joanne.chisolm@nationwidechildrens.org</email>
    </contact_backup>
    <investigator>
      <last_name>Mark Galantowicz, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Drews JD, Pepper VK, Best CA, Szafron JM, Cheatham JP, Yates AR, Hor KN, Zbinden JC, Chang YC, Mirhaidari GJM, Ramachandra AB, Miyamoto S, Blum KM, Onwuka EA, Zakko J, Kelly J, Cheatham SL, King N, Reinhardt JW, Sugiura T, Miyachi H, Matsuzaki Y, Breuer J, Heuer ED, West TA, Shoji T, Berman D, Boe BA, Asnes J, Galantowicz M, Matsumura G, Hibino N, Marsden AL, Pober JS, Humphrey JD, Shinoka T, Breuer CK. Spontaneous reversal of stenosis in tissue-engineered vascular grafts. Sci Transl Med. 2020 Apr 1;12(537):eaax6919. doi: 10.1126/scitranslmed.aax6919.</citation>
    <PMID>32238576</PMID>
  </reference>
  <reference>
    <citation>Ruiz-Rosado JD, Lee YU, Mahler N, Yi T, Robledo-Avila F, Martinez-Saucedo D, Lee AY, Shoji T, Heuer E, Yates AR, Pober JS, Shinoka T, Partida-Sanchez S, Breuer CK. Angiotensin II receptor I blockade prevents stenosis of tissue engineered vascular grafts. FASEB J. 2018 Jun 15;32(12):fj201800458. doi: 10.1096/fj.201800458. Online ahead of print.</citation>
    <PMID>29906242</PMID>
  </reference>
  <reference>
    <citation>Lee YU, Mahler N, Best CA, Tara S, Sugiura T, Lee AY, Yi T, Hibino N, Shinoka T, Breuer C. Rational design of an improved tissue-engineered vascular graft: determining the optimal cell dose and incubation time. Regen Med. 2016 Mar;11(2):159-67. doi: 10.2217/rme.15.85. Epub 2016 Feb 29.</citation>
    <PMID>26925512</PMID>
  </reference>
  <reference>
    <citation>Kurobe H, Tara S, Maxfield MW, Rocco KA, Bagi PS, Yi T, Udelsman BV, Dean EW, Khosravi R, Powell HM, Shinoka T, Breuer CK. Comparison of the biological equivalence of two methods for isolating bone marrow mononuclear cells for fabricating tissue-engineered vascular grafts. Tissue Eng Part C Methods. 2015 Jun;21(6):597-604. doi: 10.1089/ten.TEC.2014.0442. Epub 2014 Dec 29.</citation>
    <PMID>25397868</PMID>
  </reference>
  <reference>
    <citation>Kurobe H, Maxfield MW, Naito Y, Cleary M, Stacy MR, Solomon D, Rocco KA, Tara S, Lee AY, Sinusas AJ, Snyder EL, Shinoka T, Breuer CK. Comparison of a closed system to a standard open technique for preparing tissue-engineered vascular grafts. Tissue Eng Part C Methods. 2015 Jan;21(1):88-93. doi: 10.1089/ten.TEC.2014.0160.</citation>
    <PMID>24866863</PMID>
  </reference>
  <reference>
    <citation>Hibino N, McGillicuddy E, Matsumura G, Ichihara Y, Naito Y, Breuer C, Shinoka T. Late-term results of tissue-engineered vascular grafts in humans. J Thorac Cardiovasc Surg. 2010 Feb;139(2):431-6, 436.e1-2. doi: 10.1016/j.jtcvs.2009.09.057.</citation>
    <PMID>20106404</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>August 1, 2023</last_update_submitted>
  <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fontan</keyword>
  <keyword>TEVG</keyword>
  <keyword>Tissue Engineered Vascular Graft</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Univentricular Heart</mesh_term>
    <mesh_term>Heart Defects, Congenital</mesh_term>
    <mesh_term>Hypoplastic Left Heart Syndrome</mesh_term>
    <mesh_term>Cardiovascular Abnormalities</mesh_term>
    <mesh_term>Tricuspid Atresia</mesh_term>
    <mesh_term>Congenital Abnormalities</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Biological Samples: We plan to make available representative samples of the bone marrow-derived mononuclear cells and seeded scaffold to a NIH-designated entity (RM Innovation Catalyst) for in depth and independent characterization. Specifically, for each TEVG manufactured, 1 ml of bone marrow-derived mononuclear cells and a 5mm x 5mm section of the seeded scaffold will be sampled, packed, and transported to the RM Innovation Catalyst per their instructions. In addition, copies of the batch record and completed certificate of analysis will be forwarded to the NIH-designated laboratory.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Prior to study initiation, the US FDA will have a comprehensive description of the processes followed to assure the accuracy, reliability, integrity, availability, and authenticity of required records and signatures supporting the data reported in the CSR will be provided to the Agency for confirmation that it will support a regulatory filing for TEVG. Every 6 months throughout the study, data will be shared with RM Innovation Catalyst, with a final locked data set no later than six months prior to the end of the award. Data from our long-term follow up policy will be made available on an annual basis if requested by the RM Innovation Catalyst or the NIH.</ipd_time_frame>
    <ipd_access_criteria>De-identified data will be provided to RM Innovation Catalyst. A Clinical Study Report will be submitted to the US FDA following the International Conference on Harmonization E3 Guideline for Industry: Structure and Content of Clinical Study Reports. Summary results of the trial will be submitted to ClinicalTrial.gov within one year of the primary completion date (per regulation and NIH policy). Results of screening tests and subjects participation in the study and ongoing test results will be shared with their primary care physician and/or primary cardiologist if cardiac care is being provided outside of Nationwide Children's Hospital.</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT04467671
org study id: IDE18703
secondary id: 1UG3HL148693
secondary id: 1UH3HL148693
nct id: NCT04467671
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG
      as vascular conduits for extracardiac total cavopulmonary connection.
This investigation is a prospective, open-labeled clinical trial determining the safety of
      the use of tissue engineered vascular grafts as conduits for EC TCPC. Patients will be
      monitored for adverse events (AE) and serious adverse events (SAE). Special attention will be
      paid to the incidence of stenosis. We will determine graft-related morbidity and mortality
      for the second generation TEVGs which will include any post-operative complication such as
      any aneurismal dilation, stenosis, thromboembolic or infectious event that requires treatment
      and is thought to be caused by the graft as determined by the investigators and confirmed by
      the data safety monitoring board. The graft related complication rates will be compared
      between the first and second generation TEVGs. An interim analysis will be performed to
      assess the incidence of early (<6 month) graft-related complications in the first 6 enrolled
      patients. Safety and tolerability will be assessed through serial imaging, to determine the
      effect of growth and remodeling on graft performance through echocardiography and
      4-dimensional MRI. All appropriate patients requiring EC TCPC who meet study
      inclusion/exclusion criteria will be evaluated for enrollment in the clinical trial. All
      enrolled subjects will be required to have follow-up visits at Nationwide Children's Hospital
      for a minimum of 2 years following implant. After obtaining informed consent for the
      patient's parents, patients with single ventricle cardiac anomalies will undergo EC TCPC
      using a tissue engineered conduit. Post-operative care and monitoring will follow an
      established, standardized, clinical algorithm in which the patient's clinical status
      including complications and measurements of graft function will be serially evaluated and
      recorded over a two year period using physical examination, echocardiography, and MRI.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety and Tolerability of TEVG
time frame: 2 years
description: Assessed through graft related complications as determined by serial echocardiogram
measure: Safety and Tolerability of TEVG
time frame: 2 years
description: Assessed through graft related complications as determined by serial MRI
measure: Safety and Tolerability of TEVG
time frame: 2 years
description: Assessed through adverse events
measure: Efficacy of TEVG
time frame: 2 years
description: Evaluate graft performance based on MRI
measure: Efficacy of TEVG
time frame: 2 years
description: Measured graft volume(mL) as determined by MRI
measure: Efficacy of TEVG
time frame: 2 years
description: Measured graft length (mm) as determined by MRI
arm group label: Tissue Engineered Vascular Grafts
arm group type: Experimental
intervention type: Combination Product
intervention name: Tissue Engineered Vascular Grafts
description: Patients will undergo EC TCPC interposition grafting with a tissue engineered vascular graft and serial magnetic resonance imaging (MRI)
arm group label: Tissue Engineered Vascular Grafts
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Christopher Breuer, MD
role: Study Chair
affiliation: Nationwide Children's Hospital
last name: Toshiharu Shinoka, MD/PhD
role: Study Chair
affiliation: Nationwide Children's Hospital
last name: Mark Galantowicz, MD
role: Principal Investigator
affiliation: Nationwide Children's Hospital
last name: Samantha Fichtner, BSN, RN
phone: 614-355-5764
email: samantha.fichtner@nationwidechildrens.org
last name: Joanne Chisolm, MSN, RN
email: joanne.chisolm@nationwidechildrens.org
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
citation: Drews JD, Pepper VK, Best CA, Szafron JM, Cheatham JP, Yates AR, Hor KN, Zbinden JC, Chang YC, Mirhaidari GJM, Ramachandra AB, Miyamoto S, Blum KM, Onwuka EA, Zakko J, Kelly J, Cheatham SL, King N, Reinhardt JW, Sugiura T, Miyachi H, Matsuzaki Y, Breuer J, Heuer ED, West TA, Shoji T, Berman D, Boe BA, Asnes J, Galantowicz M, Matsumura G, Hibino N, Marsden AL, Pober JS, Humphrey JD, Shinoka T, Breuer CK. Spontaneous reversal of stenosis in tissue-engineered vascular grafts. Sci Transl Med. 2020 Apr 1;12(537):eaax6919. doi: 10.1126/scitranslmed.aax6919.
PMID: 32238576
citation: Ruiz-Rosado JD, Lee YU, Mahler N, Yi T, Robledo-Avila F, Martinez-Saucedo D, Lee AY, Shoji T, Heuer E, Yates AR, Pober JS, Shinoka T, Partida-Sanchez S, Breuer CK. Angiotensin II receptor I blockade prevents stenosis of tissue engineered vascular grafts. FASEB J. 2018 Jun 15;32(12):fj201800458. doi: 10.1096/fj.201800458. Online ahead of print.
PMID: 29906242
citation: Lee YU, Mahler N, Best CA, Tara S, Sugiura T, Lee AY, Yi T, Hibino N, Shinoka T, Breuer C. Rational design of an improved tissue-engineered vascular graft: determining the optimal cell dose and incubation time. Regen Med. 2016 Mar;11(2):159-67. doi: 10.2217/rme.15.85. Epub 2016 Feb 29.
PMID: 26925512
citation: Kurobe H, Tara S, Maxfield MW, Rocco KA, Bagi PS, Yi T, Udelsman BV, Dean EW, Khosravi R, Powell HM, Shinoka T, Breuer CK. Comparison of the biological equivalence of two methods for isolating bone marrow mononuclear cells for fabricating tissue-engineered vascular grafts. Tissue Eng Part C Methods. 2015 Jun;21(6):597-604. doi: 10.1089/ten.TEC.2014.0442. Epub 2014 Dec 29.
PMID: 25397868
citation: Kurobe H, Maxfield MW, Naito Y, Cleary M, Stacy MR, Solomon D, Rocco KA, Tara S, Lee AY, Sinusas AJ, Snyder EL, Shinoka T, Breuer CK. Comparison of a closed system to a standard open technique for preparing tissue-engineered vascular grafts. Tissue Eng Part C Methods. 2015 Jan;21(1):88-93. doi: 10.1089/ten.TEC.2014.0160.
PMID: 24866863
citation: Hibino N, McGillicuddy E, Matsumura G, Ichihara Y, Naito Y, Breuer C, Shinoka T. Late-term results of tissue-engineered vascular grafts in humans. J Thorac Cardiovasc Surg. 2010 Feb;139(2):431-6, 436.e1-2. doi: 10.1016/j.jtcvs.2009.09.057.
PMID: 20106404
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Univentricular Heart
mesh term: Heart Defects, Congenital
mesh term: Hypoplastic Left Heart Syndrome
mesh term: Cardiovascular Abnormalities
mesh term: Tricuspid Atresia
mesh term: Congenital Abnormalities
sharing ipd: Yes
ipd description: Biological Samples: We plan to make available representative samples of the bone marrow-derived mononuclear cells and seeded scaffold to a NIH-designated entity (RM Innovation Catalyst) for in depth and independent characterization. Specifically, for each TEVG manufactured, 1 ml of bone marrow-derived mononuclear cells and a 5mm x 5mm section of the seeded scaffold will be sampled, packed, and transported to the RM Innovation Catalyst per their instructions. In addition, copies of the batch record and completed certificate of analysis will be forwarded to the NIH-designated laboratory.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Prior to study initiation, the US FDA will have a comprehensive description of the processes followed to assure the accuracy, reliability, integrity, availability, and authenticity of required records and signatures supporting the data reported in the CSR will be provided to the Agency for confirmation that it will support a regulatory filing for TEVG. Every 6 months throughout the study, data will be shared with RM Innovation Catalyst, with a final locked data set no later than six months prior to the end of the award. Data from our long-term follow up policy will be made available on an annual basis if requested by the RM Innovation Catalyst or the NIH.
ipd access criteria: De-identified data will be provided to RM Innovation Catalyst. A Clinical Study Report will be submitted to the US FDA following the International Conference on Harmonization E3 Guideline for Industry: Structure and Content of Clinical Study Reports. Summary results of the trial will be submitted to ClinicalTrial.gov within one year of the primary completion date (per regulation and NIH policy). Results of screening tests and subjects participation in the study and ongoing test results will be shared with their primary care physician and/or primary cardiologist if cardiac care is being provided outside of Nationwide Children's Hospital.