Young Donor Plasma Transfusion and Age-Related Biomarkers

Aging Clinical Trial

Official title:

Young Donor Plasma Transfusion and Age-Related Biomarkers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02803554
• Other study ID #: AM-PL-101
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: January 15, 2018

Study information

• Verified date: May 2018
• Source: Ambrosia LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the beneficial effects of infusions of plasma from young donors using blood biomarkers.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 15, 2018
• Est. primary completion date: January 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• 35 years of age or older

Related Conditions & MeSH terms

• Aging

Intervention

Other:
• Plasma
Blood plasma from donors aged 25 years or younger

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ambrosia LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from before treatment to 1 month after treatment
Primary	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	Change from before treatment to 1 month after treatment
Primary	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	Change from before treatment to 1 month after treatment