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| ClinicalTrials Identifier: | NCT02803554 |
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| Updated: | 2016_06_16 |
Descriptive Information |
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| Brief title |
Young Donor Plasma Transfusion and Age-Related Biomarkers |
| Official title |
Young Donor Plasma Transfusion and Age-Related Biomarkers |
| Brief summary | |
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The purpose of the study is to evaluate the beneficial effects of infusions of plasma from young donors using blood biomarkers. |
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| Detailed description | |
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Each patient will receive an infusion of plasma derived from a young donor (<25 years of age). A panel of age-associated biomarkers will be measured before and after treatment. |
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| Phase | N/A |
| Study type | Interventional |
| Study design | Basic Science |
| Study design | Open Label |
| Study design | Single Group Assignment |
| Primary outcome | Measure: Blood biomarkers (1/3) Time Frame: Change from before treatment to 1 month after treatment Safety Issue? No Description: 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 |
| Primary outcome | Measure: Blood biomarkers (2/3) Time Frame: Change from before treatment to 1 month after treatment Safety Issue? No Description: 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 |
| Primary outcome | Measure: Blood biomarkers (3/3) Time Frame: Change from before treatment to 1 month after treatment Safety Issue? No Description: 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 |
| Enrollment | 600 (Anticipated) |
| Condition | Aging |
| Arm/Group |
Arm Label: Young donor plasma
Experimental
An infusion of plasma derived from donors aged 25 years or younger |
| Intervention |
Other: Plasma
Arm Label: Young donor plasma
Blood plasma from donors aged 25 years or younger |
Recruitment Information |
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| Status | Recruiting |
| Start date | 2016-06 |
| Last follow-up date | 2018-07 (Anticipated) |
| Primary completion date | 2018-06 (Anticipated) |
| Criteria | |
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Inclusion Criteria: |
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| Gender | Both |
| Minimum age | 35 Years |
| Healthy volunteers | Yes |
Administrative Data |
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| Organization name | Ambrosia LLC |
| Organization study ID | AM-PL-101 |
| Sponsor | Ambrosia LLC |
| Health Authority | United States: Food and Drug Administration |