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Quality of Life Improvements With Cord Blood Plasma

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ClinicalTrials.gov Identifier: NCT03229785
Recruitment Status : Not yet recruiting
First Posted : July 26, 2017
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Hexagon Therapies, LLC

Tracking Information
First Submitted Date  ICMJE July 13, 2017
First Posted Date  ICMJE July 26, 2017
Last Update Posted Date January 24, 2018
Estimated Study Start Date  ICMJE April 1, 2018
Estimated Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2017)
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. ]
SF 36 as a measure quality of life improvements compared to baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03229785 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2017)
  • 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 ]
    Blood samples will be tested for changes in biomarkers - compared to baseline measurements.
  • 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 ]
    Blood samples will be tested for changes in adrenal cortical hormone as compared to the baseline measurements.
  • 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 ]
    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).
  • 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 ]
    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.
  • 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 ]
    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.
  • 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. ]
    Blood samples will be tested to assess changes of 8-hydroxyguanine (a common marker of DNA damage) in whole blood - compared to baseline measurements.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Quality of Life Improvements With Cord Blood Plasma
Official Title  ICMJE Determining Overall Improvement in the Quality of Life of Individuals Receiving Human Umbilical Cord Blood Plasma
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Aging
Intervention  ICMJE Biological: Human Umbilical Cord Blood Plasma
Plasma collected from human umbilical cord blood
Study Arms  ICMJE Experimental: Human Umbilical Cord Blood Plasma
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: Biological: Human Umbilical Cord Blood Plasma
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 24, 2017)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2019
Estimated Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged 50 or older
  • Be willing and able to participate during the 12 month research period
  • Women - must be diagnosed with infertility or menopause

Exclusion Criteria:

  • Unable to perform tasks required for analysis of end points
  • History of being hospitalized dues to infectious disease, such as pneumonia, within the last year
  • Recent and current use of immunosuppressive drugs or HIV patients
  • Scheduled to receive organ transplant
  • Dementia or clinically relevant cognitive impairment
  • Participants of previous (within 1 month) or current clinical trials
  • Severe heart and kidney failure
  • History of alcohol or drug abuse
  • Known or suspected pregnancy
  • Chronic Hepatitis B or C
  • Diagnosis of cancer within 5 year of the study, or the possibility to contract cancer
  • Anticancer chemotherapy and radiation therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Andrew Petersen, D.O. 813-203-5675 kevin@hexagontherapies.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03229785
Other Study ID Numbers  ICMJE HEXA0001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hexagon Therapies, LLC
Study Sponsor  ICMJE Hexagon Therapies, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hexagon Therapies, LLC
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP