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/NCT05991986</url>
    </required_header>
    <id_info>
      <org_study_id>2023KYPJ224</org_study_id>
      <nct_id>NCT05991986</nct_id>
    </id_info>
    <brief_title>Preparation of Patient Autologous Induced Pluripotent Stem Cell-derived Retinal Cells for AMD</brief_title>
    <official_title>Production of Patient Autologous Induced Pluripotent Stem Cell-derived Retinal Cells for Age-related Macular Degeneration</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zhongshan Ophthalmic Center, Sun Yat-sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zhongshan Ophthalmic Center, Sun Yat-sen University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This project intends to collect participant somatic cells to prepare autologous induced&#xD;
        pluripotent stem cell-derived retinal cells for future cell therapy of age-related macular&#xD;
        degeneration patient.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        One or more types of somatic cells will be collected from every participant by collecting&#xD;
        approximately 100~500 ml of midstream urine, 20~30 ml of peripheral blood, skin biopsies&#xD;
        (3mm), conjunctiva biopsies (5mm×5mm), etc. Then, these somatic cells will be used to prepare&#xD;
        patient autologous induced pluripotent stem cell-derived retinal cells for the cell therapy&#xD;
        of age-related macular degeneration patient.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">July 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2026</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>somatic cell collection</measure>
      <time_frame>2023.8.1~2026.7.31</time_frame>
      <description>somatic cell collection</description>
    </primary_outcome>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Age-Related Macular Degeneration</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>somatic cell collection</intervention_name>
      <description>One or more types of somatic cells will be collected from every participant by collecting approximately 100~500 ml of midstream urine, 20~30 ml of peripheral blood, skin biopsies (3mm), conjunctiva biopsies (5mm×5mm), etc.</description>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        somatic cells isolated from urine, peripheral blood, skin biopsies, conjunctiva biopsies,&#xD;
        etc.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          AMD patients&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Aged 55-80 years;&#xD;
  &#xD;
            2. Clinical diagnosis is consistent with the definition of advanced age-related macular&#xD;
               degeneration;&#xD;
  &#xD;
            3. The BCVA of the target eye will be lower than 20/200;&#xD;
  &#xD;
            4. -8.00 D &lt; refraction &lt; +8.00 D, 21 mm &lt; anteroposterior axis≤ 28 mm;&#xD;
  &#xD;
            5. Voluntary as test subjects, informed consent, regular follow-up on time;&#xD;
  &#xD;
            6. Voluntary as test subjects to join the associated clinical research on autologous&#xD;
               iPSC-derived retinal cell therapy for AMD (ethical approval and informed consent&#xD;
               documents will be applied and signed separately);&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Macular atrophy caused by other diseases in addition to AMD;&#xD;
  &#xD;
            2. Malignant tumor and history of malignancy;&#xD;
  &#xD;
            3. Any immune deficiency;&#xD;
  &#xD;
            4. Lens opacities (affecting the central vision), glaucoma, uveitis, retinal detachment,&#xD;
               inherited retinal dystrophy, optic neuropathy, and other ocular histories;&#xD;
  &#xD;
            5. Other intraocular surgery histories besides cataract surgery;&#xD;
  &#xD;
            6. Severe heart failure or the left ventricular ejection fraction &lt;35% in the previous 6&#xD;
               months;&#xD;
  &#xD;
            7. Dialysis or eGFR &lt;20ml/min/1.73m2;&#xD;
  &#xD;
            8. Urine protein/urine creatinine ratio ≥1g/g;&#xD;
  &#xD;
            9. Creatinine or albumin/urine creatinine ratio ≥600mg/g;&#xD;
  &#xD;
           10. Chronic liver disease with ALT three times over the upper limit of normal value;&#xD;
  &#xD;
           11. Combined with severe systemic diseases, such as heart failure, liver disease, COPD,&#xD;
               etc.&#xD;
  &#xD;
           12. Combined with severe infectious diseases, such as HIV, HBV, HCV, syphilis, etc.&#xD;
  &#xD;
           13. HCV-RNA positive, HBV-DNA &gt;103 IU/ml, or TB, etc., during the infectious period;&#xD;
  &#xD;
           14. Use anticoagulant, or the platelet function is still not restored to normal after&#xD;
               stopping antiplatelet drugs for 10 days;&#xD;
  &#xD;
           15. Abnormal blood coagulation function or other laboratory tests;&#xD;
  &#xD;
           16. Use glucocorticoids, immunosuppressive drugs, or antipsychotic drugs in the previous 3&#xD;
               months;&#xD;
  &#xD;
           17. Use antipsychotic drugs in the previous 3 months, such as antidepressants drugs,&#xD;
               antimanic drugs, etc.&#xD;
  &#xD;
           18. Allergy to tacrolimus or other macrolides;&#xD;
  &#xD;
           19. A history of addiction to alcoholism or prohibited drugs;&#xD;
  &#xD;
           20. Be participating in other intervention clinical trials or receiving other study&#xD;
               medications;&#xD;
  &#xD;
           21. Informed refusal；&#xD;
  &#xD;
           22. Some other situations which might increase the risks of the subjects or interfere with&#xD;
               clinical trials, such as mental disorders, cognitive dysfunction, etc.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>55 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Xiufeng Zhong, Doctor</last_name>
      <role>Study Director</role>
      <affiliation>Zhongshan Ophthalmic Center, Sun Yat-sen University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Wenjing Yin</last_name>
      <phone>020-87330290</phone>
      <email>wenjingyina@163.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 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>Zhongshan Ophthalmic Center, Sun Yat-sen University</investigator_affiliation>
      <investigator_full_name>Xiufeng Zhong</investigator_full_name>
      <investigator_title>Prof</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Macular Degeneration</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/NCT05991986
  org study id: 2023KYPJ224
  nct id: NCT05991986
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This project intends to collect participant somatic cells to prepare autologous induced
        pluripotent stem cell-derived retinal cells for future cell therapy of age-related macular
        degeneration patient.
  One or more types of somatic cells will be collected from every participant by collecting
        approximately 100~500 ml of midstream urine, 20~30 ml of peripheral blood, skin biopsies
        (3mm), conjunctiva biopsies (5mm×5mm), etc. Then, these somatic cells will be used to prepare
        patient autologous induced pluripotent stem cell-derived retinal cells for the cell therapy
        of age-related macular degeneration patient.
  observational model: Other
  time perspective: Other
  measure: somatic cell collection
  time frame: 2023.8.1~2026.7.31
  description: somatic cell collection
  intervention type: Other
  intervention name: somatic cell collection
  description: One or more types of somatic cells will be collected from every participant by collecting approximately 100~500 ml of midstream urine, 20~30 ml of peripheral blood, skin biopsies (3mm), conjunctiva biopsies (5mm×5mm), etc.
  somatic cells isolated from urine, peripheral blood, skin biopsies, conjunctiva biopsies,
        etc.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 55 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Xiufeng Zhong, Doctor
  role: Study Director
  affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
  last name: Wenjing Yin
  phone: 020-87330290
  email: wenjingyina@163.com
  responsible party type: Principal Investigator
  investigator affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
  investigator full name: Xiufeng Zhong
  investigator title: Prof
  mesh term: Macular Degeneration