<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/NCT03229785</url>
  </required_header>
  <id_info>
    <org_study_id>HEXA0001</org_study_id>
    <nct_id>NCT03229785</nct_id>
  </id_info>
  <brief_title>Quality of Life Improvements With Cord Blood Plasma</brief_title>
  <official_title>Determining Overall Improvement in the Quality of Life of Individuals Receiving Human Umbilical Cord Blood Plasma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hexagon Therapies, LLC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hexagon Therapies, LLC</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study aims to look at whether human umbilical cord blood plasma (HUCBP) is safe for&#xD;
      intravascular (iv) administration; and whether it provides any reversal of frailty or other&#xD;
      age-related biological measures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants that take part in this experimental treatment will receive six HUCBP infusions&#xD;
      over a six month period, with a final check-up occuring six months after the last infusion.&#xD;
      Blood samples will be collected before receiving each HUCBP infusion, and at the last&#xD;
      check-up. Participants will also be asked to complete a medical questionnaire (SF 36) prior&#xD;
      to the first infusion, and prior to each subsequent infusion. The medical questionnaire is&#xD;
      four (4) pages in length and includes comprehensive questions about previous medical health&#xD;
      and history.&#xD;
&#xD;
      Participation in the experimental treatment will involve monitoring by the Principal Doctor&#xD;
      for a period of twelve months after the initial infusion of HUCBP. A second infusion is&#xD;
      planned for one month after the initial infusion, a third infusion is planned for two months&#xD;
      after the initial infusion, a fourth infusion is planned for three months after the initial&#xD;
      infusion, a fifth infusion is planned for four months after the initial infusion,and a sixth&#xD;
      infusion is planned for five months after the initial infusion. Participants will be asked to&#xD;
      undergo the same blood tests and physical examinations performed at the time of the initial&#xD;
      infusion at each of the five subsequent infusions (i.e. at one, two, three, four, and five&#xD;
      months after the initial infusion). Twelve months after the initial infusion participants&#xD;
      will be asked to attend for final blood tests and physical examinations. There will be no&#xD;
      HUCBP infusion at the twelve-month visit.&#xD;
&#xD;
      Assessment criteria for the study include: (1) Short Form (36) Health Survey (SF 36); (2)&#xD;
      Biomarkers of inflammation, oxidative stress, and growth factors; (3) Adrenal cortical&#xD;
      hormone levels; (4) Telomere length; (5) Hand grip strength; (6) Body fat measurement; (7)&#xD;
      DNA damage; and (8) Overall safety of intravenous administration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">April 1, 2018</start_date>
  <completion_date type="Anticipated">August 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2019</primary_completion_date>
  <phase>Phase 1</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Short Form (36) Health Survey (SF 36)</measure>
    <time_frame>The investigators will determine changes in SF 36 scores collected at baseline and at 1 month after HUCBP infusion.</time_frame>
    <description>SF 36 as a measure quality of life improvements compared to baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biomarkers of inflammation and oxidative stress.</measure>
    <time_frame>Blood samples will be collected the day before the first infusion and 1 month after HUCBP infusion</time_frame>
    <description>Blood samples will be tested for changes in biomarkers - compared to baseline measurements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adrenal cortical hormone levels as a measure of efficacy for anti-aging effects.</measure>
    <time_frame>Testing will occur using blood samples that will be collected the day before the first infusion and 1 month after HUCBP infusion</time_frame>
    <description>Blood samples will be tested for changes in adrenal cortical hormone as compared to the baseline measurements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Telomere length as a measure of efficacy for anti-aging effects.</measure>
    <time_frame>Testing will occur using blood samples that will be collected the day before the first infusion and 1 month after HUCBP infusion</time_frame>
    <description>Blood samples will be tested for changes in the length of the telomere as compared to the baseline measurements (in particular, the investigators will be looking to see if HUCBP infusion protects telomere from shortening).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hand grip strength as metric of anti-aging effects</measure>
    <time_frame>Each participant will perform the grip strength test on the day of the first infusion (baseline) and 1 month after HUCBP infusion</time_frame>
    <description>Hand grip strength will be tested on the day of the initial infusion and 1 month after HUCBP infusion. The investigators will assess changes in handgrip strength compared to the baseline, collected on the day of the first infusion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body fat measurements</measure>
    <time_frame>Body fat measurements of each participant will occur one day before the first infusion and 1 month after HUCBP infusion</time_frame>
    <description>Baseline body-fat measurements will be taken on the day of the first HUCBP infusion using calipers. These measurements will be compared to additional measurements collected 1 month after HUCBP infusion. The investigators will assess changes in body-fat measurements compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extent of DNA damage as a measure of efficacy for anti-aging effects</measure>
    <time_frame>White blood cells isolated from blood samples collected the day before the first infusion and 1 month after HUCBP infusion.</time_frame>
    <description>Blood samples will be tested to assess changes of 8-hydroxyguanine (a common marker of DNA damage) in whole blood - compared to baseline measurements.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Aging</condition>
  <arm_group>
    <arm_group_label>Human Umbilical Cord Blood Plasma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Six intravenous infusions of human umbilical cord blood plasma (HUCBP) during a twelve month study period. The amount of HUCBP being infused on each occasion is 50 mL.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Human Umbilical Cord Blood Plasma</intervention_name>
    <description>Plasma collected from human umbilical cord blood</description>
    <arm_group_label>Human Umbilical Cord Blood Plasma</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 50 or older&#xD;
&#xD;
          -  Be willing and able to participate during the 12 month research period&#xD;
&#xD;
          -  Women - must be diagnosed with infertility or menopause&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to perform tasks required for analysis of end points&#xD;
&#xD;
          -  History of being hospitalized dues to infectious disease, such as pneumonia, within&#xD;
             the last year&#xD;
&#xD;
          -  Recent and current use of immunosuppressive drugs or HIV patients&#xD;
&#xD;
          -  Scheduled to receive organ transplant&#xD;
&#xD;
          -  Dementia or clinically relevant cognitive impairment&#xD;
&#xD;
          -  Participants of previous (within 1 month) or current clinical trials&#xD;
&#xD;
          -  Severe heart and kidney failure&#xD;
&#xD;
          -  History of alcohol or drug abuse&#xD;
&#xD;
          -  Known or suspected pregnancy&#xD;
&#xD;
          -  Chronic Hepatitis B or C&#xD;
&#xD;
          -  Diagnosis of cancer within 5 year of the study, or the possibility to contract cancer&#xD;
&#xD;
          -  Anticancer chemotherapy and radiation therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Andrew Petersen, D.O.</last_name>
    <phone>813-203-5675</phone>
    <email>kevin@hexagontherapies.com</email>
  </overall_contact>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>July 13, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>January 22, 2018</last_update_submitted>
  <last_update_submitted_qc>January 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03229785
org study id: HEXA0001
nct id: NCT03229785
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to look at whether human umbilical cord blood plasma (HUCBP) is safe for
      intravascular (iv) administration; and whether it provides any reversal of frailty or other
      age-related biological measures.
Participants that take part in this experimental treatment will receive six HUCBP infusions
      over a six month period, with a final check-up occuring six months after the last infusion.
      Blood samples will be collected before receiving each HUCBP infusion, and at the last
      check-up. Participants will also be asked to complete a medical questionnaire (SF 36) prior
      to the first infusion, and prior to each subsequent infusion. The medical questionnaire is
      four (4) pages in length and includes comprehensive questions about previous medical health
      and history.

      Participation in the experimental treatment will involve monitoring by the Principal Doctor
      for a period of twelve months after the initial infusion of HUCBP. A second infusion is
      planned for one month after the initial infusion, a third infusion is planned for two months
      after the initial infusion, a fourth infusion is planned for three months after the initial
      infusion, a fifth infusion is planned for four months after the initial infusion,and a sixth
      infusion is planned for five months after the initial infusion. Participants will be asked to
      undergo the same blood tests and physical examinations performed at the time of the initial
      infusion at each of the five subsequent infusions (i.e. at one, two, three, four, and five
      months after the initial infusion). Twelve months after the initial infusion participants
      will be asked to attend for final blood tests and physical examinations. There will be no
      HUCBP infusion at the twelve-month visit.

      Assessment criteria for the study include: (1) Short Form (36) Health Survey (SF 36); (2)
      Biomarkers of inflammation, oxidative stress, and growth factors; (3) Adrenal cortical
      hormone levels; (4) Telomere length; (5) Hand grip strength; (6) Body fat measurement; (7)
      DNA damage; and (8) Overall safety of intravenous administration.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: The Short Form (36) Health Survey (SF 36)
time frame: The investigators will determine changes in SF 36 scores collected at baseline and at 1 month after HUCBP infusion.
description: SF 36 as a measure quality of life improvements compared to baseline
measure: Biomarkers of inflammation and oxidative stress.
time frame: Blood samples will be collected the day before the first infusion and 1 month after HUCBP infusion
description: Blood samples will be tested for changes in biomarkers - compared to baseline measurements.
measure: Adrenal cortical hormone levels as a measure of efficacy for anti-aging effects.
time frame: Testing will occur using blood samples that will be collected the day before the first infusion and 1 month after HUCBP infusion
description: Blood samples will be tested for changes in adrenal cortical hormone as compared to the baseline measurements.
measure: Telomere length as a measure of efficacy for anti-aging effects.
time frame: Testing will occur using blood samples that will be collected the day before the first infusion and 1 month after HUCBP infusion
description: Blood samples will be tested for changes in the length of the telomere as compared to the baseline measurements (in particular, the investigators will be looking to see if HUCBP infusion protects telomere from shortening).
measure: Hand grip strength as metric of anti-aging effects
time frame: Each participant will perform the grip strength test on the day of the first infusion (baseline) and 1 month after HUCBP infusion
description: Hand grip strength will be tested on the day of the initial infusion and 1 month after HUCBP infusion. The investigators will assess changes in handgrip strength compared to the baseline, collected on the day of the first infusion.
measure: Body fat measurements
time frame: Body fat measurements of each participant will occur one day before the first infusion and 1 month after HUCBP infusion
description: Baseline body-fat measurements will be taken on the day of the first HUCBP infusion using calipers. These measurements will be compared to additional measurements collected 1 month after HUCBP infusion. The investigators will assess changes in body-fat measurements compared to baseline.
measure: Extent of DNA damage as a measure of efficacy for anti-aging effects
time frame: White blood cells isolated from blood samples collected the day before the first infusion and 1 month after HUCBP infusion.
description: Blood samples will be tested to assess changes of 8-hydroxyguanine (a common marker of DNA damage) in whole blood - compared to baseline measurements.
arm group label: Human Umbilical Cord Blood Plasma
arm group type: Experimental
description: Six intravenous infusions of human umbilical cord blood plasma (HUCBP) during a twelve month study period. The amount of HUCBP being infused on each occasion is 50 mL.
intervention type: Biological
intervention name: Human Umbilical Cord Blood Plasma
description: Plasma collected from human umbilical cord blood
arm group label: Human Umbilical Cord Blood Plasma
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andrew Petersen, D.O.
phone: 813-203-5675
email: kevin@hexagontherapies.com
responsible party type: Sponsor
sharing ipd: No