Aging Clinical Trial - Quality of Life Improvements With Cord Blood Plasma

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Aging

Clinical Trial Details

NCT number	NCT03229785
Study type	Interventional
Source	Hexagon Therapies, LLC
Contact	Andrew Petersen, D.O.
Phone	813-203-5675
Email	kevin@hexagontherapies.com
Status	Not yet recruiting
Phase	Phase 1
Start date	April 1, 2018
Completion date	August 1, 2019

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.