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/NCT05967325</url>
    </required_header>
    <id_info>
      <org_study_id>KunmingTH_HZ_003</org_study_id>
      <nct_id>NCT05967325</nct_id>
    </id_info>
    <brief_title>SVF Combined With Functional Self-assembling Peptide Nanofiber Hydrogels in the Treatment of Spinal Cord Injury</brief_title>
    <official_title>Safety and Feasibility of Stromal Vascular Fraction (SVF) Combined With Functional Self-assembling Peptide Nanofiber Hydrogels in the Treatment of Spinal Cord Injury</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kunming Tongren Hospital</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kunming Tongren Hospital</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>
        Traumatic spinal cord injury (SCI) is a severe medical problem experienced by people&#xD;
        worldwide with high mortality and long term morbidity. Although progress has been made in&#xD;
        understanding cellular and molecular mechanisms of SCI, treatment and management protocols&#xD;
        aimed at ameliorating neurologic damage in patients remain ineffective. Cells and&#xD;
        biomaterials offer new hope for the treatment of SCI.&#xD;
  &#xD;
        Up to now, there have been many studies on the treatment of SCI using cells and biomaterials.&#xD;
        Stromal Vascular Fraction (SVF) is a heterogeneous mixture of cells obtained from adipose&#xD;
        tissue. These cells include adipose-derived stem cells, endothelial cells, endothelial&#xD;
        progenitor cells, pericytes, T cells, and other immune cells. SVF has strong self-renewal,&#xD;
        proliferation and differentiation potential, it can replace necrotic cells and synthesize a&#xD;
        variety of bioactive factors through paracrine and autocrine, activate cell and vascular&#xD;
        regeneration pathways. Therefore, SVF shows significant advantages. The sequence of&#xD;
        functional self-assembling peptide nanofiber hydrogels (hereinafter referred to as hydrogels)&#xD;
        is HGF(RADA)4RIKVAV (H: histidine; G: Glycine; F: phenylalanine; R: arginine; A: Alanine; D:&#xD;
        aspartic acid; I: isoleucine; K: Lysine; V: valerine). The hydrogel is based on the short&#xD;
        peptide RADA16 ((RADA)4, which is already available in the product PuramatrixTM for clinical&#xD;
        hemostasis and cell culture, but the aqueous solution of PuramatrixTM is acidic which harms&#xD;
        cells and tissues upon direct contact. While the hydrogels in this study is pH neutral and&#xD;
        does not harm cells and tissues. Articles published by the provider demonstrate that&#xD;
        hydrogels can support 3D stem cell growth, have good biocompatibility in vivo (animal spinal&#xD;
        cord), and promote neural regeneration after SCI. The chemical structure of the hydrogels is&#xD;
        simple and clear, and the degradation product is amino acid. Therefore, SVF and the hydrogel&#xD;
        from functional self-assembling peptide are combined for SCI repair in the study.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 15, 2023</start_date>
    <completion_date type="Anticipated">July 15, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 15, 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>Change from Baseline Kunming Locomotor Scale (KLS) at 12 months</measure>
      <time_frame>Day 0, Month 12</time_frame>
      <description>Scale from minimum (1) to maximum (10), higher scales mean a better outcome.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline Walking Index for Spinal Cord Injury at 12 months</measure>
      <time_frame>Day 0, Month 12</time_frame>
      <description>Score from minimum (0) to maximum (20), higher scores mean a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline American Spinal Injury Association International Standards for Neurologic Classification of Spinal Cord Injury at 12 months</measure>
      <time_frame>Day 0, Month 12</time_frame>
      <description>Motor scores: bilateral upper and lower extremities total: minimum (0) to maximum (100), higher scores mean a better outcome.&#xD;
  Sensory scores: bilateral light touch total from minimum (0) and maximum (112), bilateral pin prick from minimum (0) and maximum (112), higher scores mean a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline Spinal Cord Independence Measure at 12 months</measure>
      <time_frame>Day 0, Month 12</time_frame>
      <description>Score from minimum (0) to maximum (100), higher scores mean a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline Modified Ashworth Scale (MAS) at 12 months</measure>
      <time_frame>Day 0, Month 12</time_frame>
      <description>Scale from minimum (0) to maximum (4), higher scales mean a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline International Index of Erectile Function at 12 months</measure>
      <time_frame>Day 0, Month 12</time_frame>
      <description>Male subjects only. Score from minimum (0) to maximum (25), higher scores mean a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline Numerical rating scale at 12 months</measure>
      <time_frame>Day 0, Month 12</time_frame>
      <description>Scale from minimum (0) to maximum (10), higher scales mean a worse outcome.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Safety Issues</condition>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Stromal Vascular Fraction (SVF) combined with Functional self-assembling peptide nanofiber hydrogels</intervention_name>
      <description>Transplantation of SVF and biomimetic nanohydrogel</description>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male or female adults, 18-60 years of age, with a clinical diagnosis of chronic&#xD;
               traumatic SCI (≥ 3 months after SCI)&#xD;
  &#xD;
            2. Neurological examination: ASIA-A&#xD;
  &#xD;
            3. Both the spinal and neurological levels of injury were between T1-T12&#xD;
  &#xD;
            4. Subjects must be able to read, write and complete visual analogue scale&#xD;
  &#xD;
            5. Voluntarily signs and dates an informed Consent form, approved by an Institutional&#xD;
               Review Board (IRB)/Independent Ethics Committee (IEC), prior to any study-specific&#xD;
               procedures.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subjects with osteoporosis or had joint disease&#xD;
  &#xD;
            2. Severe head injury&#xD;
  &#xD;
            3. Severe pressure sore&#xD;
  &#xD;
            4. Sign of kidney, cardiovascular, liver disorders&#xD;
  &#xD;
            5. Subjects with internal medical and/or infectious diseases (including but not limited&#xD;
               to Hepatitis B and HIV carriers)&#xD;
  &#xD;
            6. Pregnant women or women at lactation stages&#xD;
  &#xD;
            7. Medically or mentally unstable according to the judgment of the investigator&#xD;
  &#xD;
            8. History of multiple sclerosis or peripheral demyelination&#xD;
  &#xD;
            9. Any criteria which, in the opinion of the investigator, suggests that the subject&#xD;
               would not be compliant with the study protocol&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>HUI ZHU</last_name>
      <phone>(86)13888092115</phone>
      <email>kmzhuhui@sina.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Kunming Tongren Hospital</name>
        <address>
          <city>Kunming</city>
          <state>Yunnan</state>
          <zip>650000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hui Zhu, MD</last_name>
        <phone>(86)13888092115</phone>
        <email>kmzhuhui@sina.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Kunming Tongren Hospital</investigator_affiliation>
      <investigator_full_name>Hui Zhu</investigator_full_name>
      <investigator_title>Director</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spinal Cord Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05967325
  org study id: KunmingTH_HZ_003
  nct id: NCT05967325
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Traumatic spinal cord injury (SCI) is a severe medical problem experienced by people
        worldwide with high mortality and long term morbidity. Although progress has been made in
        understanding cellular and molecular mechanisms of SCI, treatment and management protocols
        aimed at ameliorating neurologic damage in patients remain ineffective. Cells and
        biomaterials offer new hope for the treatment of SCI.
  
        Up to now, there have been many studies on the treatment of SCI using cells and biomaterials.
        Stromal Vascular Fraction (SVF) is a heterogeneous mixture of cells obtained from adipose
        tissue. These cells include adipose-derived stem cells, endothelial cells, endothelial
        progenitor cells, pericytes, T cells, and other immune cells. SVF has strong self-renewal,
        proliferation and differentiation potential, it can replace necrotic cells and synthesize a
        variety of bioactive factors through paracrine and autocrine, activate cell and vascular
        regeneration pathways. Therefore, SVF shows significant advantages. The sequence of
        functional self-assembling peptide nanofiber hydrogels (hereinafter referred to as hydrogels)
        is HGF(RADA)4RIKVAV (H: histidine; G: Glycine; F: phenylalanine; R: arginine; A: Alanine; D:
        aspartic acid; I: isoleucine; K: Lysine; V: valerine). The hydrogel is based on the short
        peptide RADA16 ((RADA)4, which is already available in the product PuramatrixTM for clinical
        hemostasis and cell culture, but the aqueous solution of PuramatrixTM is acidic which harms
        cells and tissues upon direct contact. While the hydrogels in this study is pH neutral and
        does not harm cells and tissues. Articles published by the provider demonstrate that
        hydrogels can support 3D stem cell growth, have good biocompatibility in vivo (animal spinal
        cord), and promote neural regeneration after SCI. The chemical structure of the hydrogels is
        simple and clear, and the degradation product is amino acid. Therefore, SVF and the hydrogel
        from functional self-assembling peptide are combined for SCI repair in the study.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change from Baseline Kunming Locomotor Scale (KLS) at 12 months
  time frame: Day 0, Month 12
  description: Scale from minimum (1) to maximum (10), higher scales mean a better outcome.
  measure: Change from Baseline Walking Index for Spinal Cord Injury at 12 months
  time frame: Day 0, Month 12
  description: Score from minimum (0) to maximum (20), higher scores mean a better outcome.
  measure: Change from Baseline American Spinal Injury Association International Standards for Neurologic Classification of Spinal Cord Injury at 12 months
  time frame: Day 0, Month 12
  description: Motor scores: bilateral upper and lower extremities total: minimum (0) to maximum (100), higher scores mean a better outcome.
  Sensory scores: bilateral light touch total from minimum (0) and maximum (112), bilateral pin prick from minimum (0) and maximum (112), higher scores mean a better outcome.
  measure: Change from Baseline Spinal Cord Independence Measure at 12 months
  time frame: Day 0, Month 12
  description: Score from minimum (0) to maximum (100), higher scores mean a better outcome.
  measure: Change from Baseline Modified Ashworth Scale (MAS) at 12 months
  time frame: Day 0, Month 12
  description: Scale from minimum (0) to maximum (4), higher scales mean a worse outcome.
  measure: Change from Baseline International Index of Erectile Function at 12 months
  time frame: Day 0, Month 12
  description: Male subjects only. Score from minimum (0) to maximum (25), higher scores mean a better outcome.
  measure: Change from Baseline Numerical rating scale at 12 months
  time frame: Day 0, Month 12
  description: Scale from minimum (0) to maximum (10), higher scales mean a worse outcome.
  intervention type: Procedure
  intervention name: Stromal Vascular Fraction (SVF) combined with Functional self-assembling peptide nanofiber hydrogels
  description: Transplantation of SVF and biomimetic nanohydrogel
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: HUI ZHU
  phone: (86)13888092115
  email: kmzhuhui@sina.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Kunming Tongren Hospital
  investigator full name: Hui Zhu
  investigator title: Director
  mesh term: Spinal Cord Injuries
  sharing ipd: Undecided