Quality of Life Improvements With Cord Blood Plasma

NCT ID: NCT03229785

Last Updated: 2018-01-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2019-08-01

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.

Conditions

Aging

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Human Umbilical Cord Blood Plasma

Intervention Type: BIOLOGICAL

Plasma collected from human umbilical cord blood

Interventions

Human Umbilical Cord Blood Plasma

Plasma collected from human umbilical cord blood

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hexagon Therapies, LLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Andrew Petersen, D.O.

Role: CONTACT

kevin@hexagontherapies.com

813-203-5675

Other Identifiers

HEXA0001

Identifier Type: -

Identifier Source: org_study_id