Quality of Life Improvements With Cord Blood Plasma

NCT03229785 | Unknown Phase 1 DMC

• 1 other identifier: HEXA0001
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Biomarkers of inflammation and oxidative stress.

  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.

  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.

  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

  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

  Body fat measurements of each participant will occur one day before the first infusion and 1 month after HUCBP infusion

Study Arms (1)

Human Umbilical Cord Blood Plasma

EXPERIMENTAL

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

Interventions

Human Umbilical Cord Blood Plasma BIOLOGICAL

Plasma collected from human umbilical cord blood

Human Umbilical Cord Blood Plasma

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hexagon Therapies, LLC: lead

Central Study Contacts

Andrew Petersen, D.O.

CONTACT

813-203-5675; kevin@hexagontherapies.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 26, 2017
• Study Start: April 1, 2018
• Primary Completion: January 31, 2019
• Study Completion: August 1, 2019
• Last Updated: January 24, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share