AgingPhase 1NCT03229785
Quality of Life Improvements With Cord Blood Plasma
A Phase 1 study testing Human Umbilical Cord Blood Plasma in people with Aging, run by Hexagon Therapies, LLC.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Human Umbilical Cord Blood Plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2018to 1 Aug 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 50 or older
- Be willing and able to participate during the 12 month research period
- Women - must be diagnosed with infertility or menopause
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Being tested
- Human Umbilical Cord Blood Plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Umbilical Cord Blood PlasmaBiological
Plasma collected from human umbilical cord blood
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Human Umbilical Cord Blood Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Short Form (36) Health Survey (SF 36)
SF 36 as a measure quality of life improvements compared to baseline
Measured: 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 tested for changes in biomarkers - compared to baseline measurements.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: White blood cells isolated from blood samples collected the day before the first infusion and 1 month after HUCBP infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start1 Apr 2018 (estimated)
- Primary completion31 Jan 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hexagon Therapies, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229785
- Sponsor's protocol ID
- HEXA0001
- Status last verified
- Jan 2018
- First submitted
- 13 Jul 2017
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Overall Improvement in the Quality of Life of Individuals Receiving Human Umbilical Cord Blood Plasma
- ClinicalTrials.gov ID
- NCT03229785
- Acronym / sponsor ID
- HEXA0001
- Conditions
- Aging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hexagon Therapies, LLCUniversity, hospital or other
- Study start
- 1 Apr 2018 (estimated)
- Primary completion
- 31 Jan 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 26 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Human Umbilical Cord Blood Plasma | Experimental | Biological: Human Umbilical Cord Blood PlasmaSix 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 50 or older
- Be willing and able to participate during the 12 month research period
- Women - must be diagnosed with infertility or menopause
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Umbilical Cord Blood PlasmaPlasma collected from human umbilical cord blood | Biological | Human Umbilical Cord Blood Plasma |
Primary outcome
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
6 secondary outcomes
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
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
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
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
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Human Umbilical Cord Blood Plasma in people with Aging, run by Hexagon Therapies, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Petersen, D.O. (813-203-5675, kevin@hexagontherapies.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2018; AzTrials last refreshed its copy on 7 Nov 2026.