AgingNCT02803554
Young Donor Plasma Transfusion and Age-Related Biomarkers
A study testing Plasma in people with Aging, run by Ambrosia LLC.
Trial summary
The purpose of the study is to evaluate the beneficial effects of infusions of plasma from young donors using blood biomarkers. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- 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
- Jun 2016to 15 Jan 2018
- Phase
- Interventional
- 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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 35 years of age or older
Who cannot join
None listed.
About this study
The purpose of the study is to evaluate the beneficial effects of infusions of plasma from young donors using blood biomarkers.
Read the detailed description
Each patient will receive an infusion of plasma derived from a young donor (16-25 years of age). A panel of age-associated biomarkers will be measured before and after treatment.
We have drawn biomarkers from clinical measures of aging and physiology, biomarkers of disease advancement, as well as biomarkers of aging from animal and human studies. These will represent a spectrum of physiologic pathways with evidence-based connections to aging. They include the physiologic processes of inflammation, neurogenesis, stem cell proliferation, blood clotting, immune function, and amyloid plaques. Organ function which will be specifically measured includes the liver, bone marrow, kidneys, pancreas, muscles, cardiovasculature, cerebrovasculature, and the thyroid. Specific disease states connected to these biomarkers include anemia, neutropenia, thrombocytopenia, obesity, diabetes, high cholesterol, elevated risk of cancer, atherosclerosis, dementia, and cataracts.
Visit us at www.ambrosiaplasma.com
- Conditions
- Aging
- Being tested
- Plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlasmaOther
Blood plasma from donors aged 25 years or younger
| Study group | Role | What they receive |
|---|---|---|
| Young donor plasma | Experimental | An infusion of plasma derived from donors aged 25 years or younger Receives: Other: Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood biomarkers (1/3)
WBC, RBC, Hemoglobin, Hematocrit, MCV, MCH, MCHC, RDW, Platelet Count, MPV, Differential, Albumin, Albumin/Globulin Ratio (calculated), Alkaline Phosphatase, ALT, AST, BUN/Creatinine Ratio (calculated), Calcium, Carbon Dioxide, Chloride, Creatinine with GFR Estimated, Globulin (calculated), Glucose, Potassium, Sodium, Total Bilirubin, Total Protein, Urea Nitrogen, Adiponectin, Alpha-1-Antitrypsin, Alpha-2-Macroglobulin, Alpha-Fetoprotein, Apolipoprotein A-I, Apolipoprotein A-II, Apolipoprotein C-I, Apolipoprotein C-III
Measured: Change from before treatment to 1 month after treatment
Blood biomarkers (2/3)
Apolipoprotein H, Apolipoprotein(a), Beta-2-Microglobulin, Brain-Derived Neurotrophic Factor, C-Reactive Protein, CD40 Ligand, Cancer Antigen 125, Cancer Antigen 19-9, Carcinoembryonic Antigen, Complement C3, EN-RAGE, Eotaxin-1, Epithelial-Derived Neutrophil-Activating Protein 78, Erythropoietin, Factor VII, Ferritin, Fibrinogen, Granulocyte Colony-Stimulating Factor, Granulocyte-Macrophage Colony-Stimulating Factor, Growth Hormone, Haptoglobin, Human Chorionic Gonadotropin beta, Immunoglobulin A, Immunoglobulin E, Immunoglobulin M, Insulin, Intercellular Adhesion Molecule 1, Interferon gamma, Interleukin-1 alpha, Interleukin-1 beta, Interleukin-1 receptor antagonist, Interleukin-10, Interleukin-12 Subunit p40, Interleukin-12 Subunit p70, Interleukin-13, Interleukin-15, Interleukin-16, Interleukin-17, Interleukin-2, Interleukin-23, Interleukin-3
Measured: Change from before treatment to 1 month after treatment
Blood biomarkers (3/3)
Interleukin-5, Interleukin-6, Interleukin-7, Interleukin-8, Leptin, Macrophage Inflammatory Protein-1 alpha, Macrophage Inflammatory Protein-1 beta, Macrophage-Derived Chemokine, Matrix Metalloproteinase-2, Matrix Metalloproteinase-3, Matrix Metalloproteinase-9, Monocyte Chemotactic Protein 1, Myeloperoxidase, Myoglobin, Neuron-Specific Enolase, Plasminogen Activator Inhibitor 1, Prostate-Specific Antigen, Free, Pulmonary and Activation-Regulated Chemokine, Serum Amyloid P-Component, Stem Cell Factor, T-Cell-Specific Protein RANTES, Thrombospondin-1, Thyroid-Stimulating Hormone, Thyroxine-Binding Globulin, Tissue Inhibitor of Metalloproteinases 1, Transthyretin, Tumor Necrosis Factor alpha, Tumor Necrosis Factor beta, Tumor necrosis factor receptor 2, Vascular Cell Adhesion Molecule-1, Endothelial Growth Factor, Vitamin D-Binding Protein, von Willebrand Factor
Measured: Change from before treatment to 1 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startJun 2016
- Primary completion15 Jan 2018
- Study completion15 Jan 2018
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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ambrosia LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803554
- Sponsor's protocol ID
- AM-PL-101
- Status last verified
- May 2018
- First submitted
- 11 Jun 2016
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Young Donor Plasma Transfusion and Age-Related Biomarkers
- ClinicalTrials.gov ID
- NCT02803554
- Acronym / sponsor ID
- AM-PL-101
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ambrosia LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 17 Jun 2016 (estimated)
- 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.
The purpose of the study is to evaluate the beneficial effects of infusions of plasma from young donors using blood biomarkers.
Detailed description
Each patient will receive an infusion of plasma derived from a young donor (16-25 years of age). A panel of age-associated biomarkers will be measured before and after treatment.
We have drawn biomarkers from clinical measures of aging and physiology, biomarkers of disease advancement, as well as biomarkers of aging from animal and human studies. These will represent a spectrum of physiologic pathways with evidence-based connections to aging. They include the physiologic processes of inflammation, neurogenesis, stem cell proliferation, blood clotting, immune function, and amyloid plaques. Organ function which will be specifically measured includes the liver, bone marrow, kidneys, pancreas, muscles, cardiovasculature, cerebrovasculature, and the thyroid. Specific disease states connected to these biomarkers include anemia, neutropenia, thrombocytopenia, obesity, diabetes, high cholesterol, elevated risk of cancer, atherosclerosis, dementia, and cataracts.
Visit us at www.ambrosiaplasma.com
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young donor plasma | Experimental | Other: PlasmaAn infusion of plasma derived from donors aged 25 years or younger |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 35 years of age or older
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PlasmaBlood plasma from donors aged 25 years or younger | Other | Young donor plasma |
Primary outcome
Blood biomarkers (1/3)
Time frame: Change from before treatment to 1 month after treatment
WBC, RBC, Hemoglobin, Hematocrit, MCV, MCH, MCHC, RDW, Platelet Count, MPV, Differential, Albumin, Albumin/Globulin Ratio (calculated), Alkaline Phosphatase, ALT, AST, BUN/Creatinine Ratio (calculated), Calcium, Carbon Dioxide, Chloride, Creatinine with GFR Estimated, Globulin (calculated), Glucose, Potassium, Sodium, Total Bilirubin, Total Protein, Urea Nitrogen, Adiponectin, Alpha-1-Antitrypsin, Alpha-2-Macroglobulin, Alpha-Fetoprotein, Apolipoprotein A-I, Apolipoprotein A-II, Apolipoprotein C-I, Apolipoprotein C-III
Blood biomarkers (2/3)
Time frame: Change from before treatment to 1 month after treatment
Apolipoprotein H, Apolipoprotein(a), Beta-2-Microglobulin, Brain-Derived Neurotrophic Factor, C-Reactive Protein, CD40 Ligand, Cancer Antigen 125, Cancer Antigen 19-9, Carcinoembryonic Antigen, Complement C3, EN-RAGE, Eotaxin-1, Epithelial-Derived Neutrophil-Activating Protein 78, Erythropoietin, Factor VII, Ferritin, Fibrinogen, Granulocyte Colony-Stimulating Factor, Granulocyte-Macrophage Colony-Stimulating Factor, Growth Hormone, Haptoglobin, Human Chorionic Gonadotropin beta, Immunoglobulin A, Immunoglobulin E, Immunoglobulin M, Insulin, Intercellular Adhesion Molecule 1, Interferon gamma, Interleukin-1 alpha, Interleukin-1 beta, Interleukin-1 receptor antagonist, Interleukin-10, Interleukin-12 Subunit p40, Interleukin-12 Subunit p70, Interleukin-13, Interleukin-15, Interleukin-16, Interleukin-17, Interleukin-2, Interleukin-23, Interleukin-3
Blood biomarkers (3/3)
Time frame: Change from before treatment to 1 month after treatment
Interleukin-5, Interleukin-6, Interleukin-7, Interleukin-8, Leptin, Macrophage Inflammatory Protein-1 alpha, Macrophage Inflammatory Protein-1 beta, Macrophage-Derived Chemokine, Matrix Metalloproteinase-2, Matrix Metalloproteinase-3, Matrix Metalloproteinase-9, Monocyte Chemotactic Protein 1, Myeloperoxidase, Myoglobin, Neuron-Specific Enolase, Plasminogen Activator Inhibitor 1, Prostate-Specific Antigen, Free, Pulmonary and Activation-Regulated Chemokine, Serum Amyloid P-Component, Stem Cell Factor, T-Cell-Specific Protein RANTES, Thrombospondin-1, Thyroid-Stimulating Hormone, Thyroxine-Binding Globulin, Tissue Inhibitor of Metalloproteinases 1, Transthyretin, Tumor Necrosis Factor alpha, Tumor Necrosis Factor beta, Tumor necrosis factor receptor 2, Vascular Cell Adhesion Molecule-1, Endothelial Growth Factor, Vitamin D-Binding Protein, von Willebrand Factor
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Plasma in people with Aging, run by Ambrosia 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 1 inclusion and 0 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: finished, as of the sponsor's last update on 11 May 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood biomarkers (1/3) (time frame: Change from before treatment to 1 month after treatment). The study lists 3 primary outcomes in all. 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 11 May 2018.