Quality of Life Improvements With Cord Blood Plasma

Determining Overall Improvement in the Quality of Life of Individuals Receiving Human Umbilical Cord Blood Plasma

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.

Study Overview

• Status: Unknown
• Conditions: Aging
• Intervention / Treatment: Biological: Human Umbilical Cord Blood Plasma

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: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Andrew Petersen, D.O.; Phone Number: 813-203-5675; Email: kevin@hexagontherapies.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Biological: Human Umbilical Cord Blood Plasma; Plasma collected from human umbilical cord blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Short Form (36) Health Survey (SF 36)	SF 36 as a measure quality of life improvements compared to baseline	The investigators will determine changes in SF 36 scores collected at baseline and at 1 month after HUCBP infusion.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarkers of inflammation and oxidative stress.	Blood samples will be tested for changes in biomarkers - compared to baseline measurements.	Blood samples will be collected the day before the first infusion and 1 month after HUCBP infusion
Adrenal cortical hormone levels as a measure of efficacy for anti-aging effects.	Blood samples will be tested for changes in adrenal cortical hormone as compared to the baseline measurements.	Testing will occur using blood samples that will be collected the day before the first infusion and 1 month after HUCBP infusion
Telomere length as a measure of efficacy for anti-aging effects.	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).	Testing will occur using blood samples that will be collected the day before the first infusion and 1 month after HUCBP infusion
Hand grip strength as metric of anti-aging effects	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.	Each participant will perform the grip strength test on the day of the first infusion (baseline) and 1 month after HUCBP infusion
Body fat measurements	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.	Body fat measurements of each participant will occur one day before the first infusion and 1 month after HUCBP infusion
Extent of DNA damage as a measure of efficacy for anti-aging effects	Blood samples will be tested to assess changes of 8-hydroxyguanine (a common marker of DNA damage) in whole blood - compared to baseline measurements.	White blood cells isolated from blood samples collected the day before the first infusion and 1 month after HUCBP infusion.

Collaborators and Investigators

• Sponsor: Hexagon Therapies, LLC

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2018
• Primary Completion (Anticipated): January 31, 2019
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: July 13, 2017
• First Submitted That Met QC Criteria: July 24, 2017
• First Posted (Actual): July 26, 2017

Study Record Updates

• Last Update Posted (Actual): January 24, 2018
• Last Update Submitted That Met QC Criteria: January 22, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: HEXA0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No