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Young Donor Plasma Transfusion and Age-Related Biomarkers

This study is currently recruiting participants.
Verified October 2016 by Ambrosia LLC
Sponsor:
ClinicalTrials.gov Identifier:
NCT02803554
First Posted: June 17, 2016
Last Update Posted: November 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Ambrosia LLC
  Purpose
The purpose of the study is to evaluate the beneficial effects of infusions of plasma from young donors using blood biomarkers.

Condition Intervention
Aging Other: Plasma

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Young Donor Plasma Transfusion and Age-Related Biomarkers

Further study details as provided by Ambrosia LLC:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 600
Study Start Date: June 2016
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Young donor plasma
An infusion of plasma derived from donors aged 25 years or younger
Other: Plasma
Blood plasma from donors aged 25 years or younger

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.ambrosiatrial.com

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 35 years of age or older

Exclusion Criteria:

  • IgA deficiency (by history)
  • Pregnancy
  • Anticoagulant for which plasma infusion is contraindicated
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02803554


Contacts
Contact: Jesse Karmazin, MD 650-714-3163 jeskarmazinmd@gmail.com

Locations
United States, California
Infusion Clinic Recruiting
Monterey, California, United States, 93940
Contact: Jesse Karmazin, MD    650-714-3163    jeskarmazinmd@gmail.com   
Sponsors and Collaborators
Ambrosia LLC
Investigators
Principal Investigator: Jesse Karmazin, MD Ambrosia LLC
  More Information

Responsible Party: Ambrosia LLC
ClinicalTrials.gov Identifier: NCT02803554     History of Changes
Other Study ID Numbers: AM-PL-101
First Submitted: June 11, 2016
First Posted: June 17, 2016
Last Update Posted: November 1, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No