A Phase 1/2 interventional study of Plasma Transfusion in Aging, sponsored by Chandra Duggirala. Status unknown at 1 site in United States. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-17.
Sponsored by Chandra Duggirala · Phase 1/2, Interventional, and Treatment
This trial is designed to study the effects of monthly transfusions of young healthy male donor plasma on biological age as assessed by DNA methylation levels, and changes in cognitive, renal, and pulmonary function, muscle strength, telomere length, testosterone, estrogen, DHEAS, IGF-1, high resolution C-Reactive protein, and expression of P16INK4a in peripheral blood T lymphocytes and skin biopsies.
Aging is a process for which there is no cure. Plasma transfusions, based on extensive animal studies, have the potential to reverse many, systemic age-related changes in the human body as well as age related chronic diseases. This is a non-randomized, uncontrolled phase I/II study to study the effects of monthly transfusions of young healthy male donor plasma on biological age as assessed by DNA methylation levels, and changes in cognitive, renal, and pulmonary function, muscle strength, telomere length, testosterone, estrogen, DHEAS, IGF-1, high resolution C-Reactive protein, and expression of p16INK4a in peripheral blood T lymphocytes and skin biopsies. To determine the safety and tolerability of monthly, 2-unit transfusions of young (\<25 years of age) healthy male donor plasma for 6 months in patients older then 40 years of age.
Exclusion Criteria:
Plasma Transfusions with 2 units of plasma per dose, for a total of 6 doses
Biological: Plasma Transfusion
All subjects will receive monthly, 2-unit transfusions of young healthy male donor plasma for total of 6 treatments. The plasma will be administered at a transfusion services facility in a manner consistent with generally accepted and standard guidelines for plasma transfusions.
Biological age as assessed by DNA methylation levels, to calculate the Epigenetic age.
The "epigenetic clock," as assessed by DNA methylation levels, which has been shown to be highly correlated with biologic age, longevity and is an independent predictor of mortality.
Time frame: Baseline to end of Month 9.
Mental (Cognitive) Function
Executive functioning, as measured by the California Stroop test
Time frame: Baseline and Month 9
Lung (Pulmonary) Function
FEV1 (Forced Expiratory Volume during the first second), and Peak Expiratory Flow
Time frame: Baseline and Month 9
Kidney (Renal) Function
Twenty-four hour urine collections will be performed by patients at Baseline and at Month 9. Creatinine Clearance, a measure of Renal function will be determined by calculating the glomerular filtration rate (GFR), which is the sum of filtration rates in all functioning nephrons.
Time frame: Baseline and Month 9
Muscle Strength
Unilateral Maximal Voluntary Isometric and Concentric Strength
Time frame: Baseline and Month 9
Telomere Length
A telomere is a region of repetitive nucleotide sequences at each end of a chromosome, which protects the end of the chromosome from deterioration or from fusion with neighboring chromosomes. Telomere shortening is associated with aging, mortality and aging-related diseases. Average telomere length will be measured in white blood cells by real time PCR technique.
Time frame: Baseline and Month 9
Testosterone
Serum free and total Testosterone levels
Time frame: Baseline and Month 9
Estrogen
Serum Estrogen levels
Time frame: Baseline and Month 9
DHEAS
Dehydroepiandrosterone is an endogenous steroid hormone that has a role in the synthesis of sex steroids (androgens and estrogens), as well as neurotrophic and other effects
Time frame: Baseline and Month 9
IGF-1
Insulin Like Growth Factor -1(IGF-1) declines continuously with aging in adults, and has been shown to mediate a number of pathways that are associated with longevity.
Time frame: Baseline and Month 9
High Sensitivity C-Reactive Protein
C-Reactive Protein is a blood protein that is a marker of inflammation. Studies have suggested that a persistent level of inflammation plays a major role in cardiovascular and other degenerative and aging related diseases.
Time frame: Baseline and Month 9
P16INK4a (A marker of cellular aging)
The cyclin- dependent kinase inhibitor CDKN2A, commonly referred to as p16INK4a or p16, has been established as a general marker of cellular senescence or aging. The expression of p16INK4a has been shown to increase exponentially with chronologic age. P16-INK4a is performed on a small specimen of blood drawn from the subjects, as well as from skin biopsy samples.
Time frame: Baseline and Month 9
Exploratory biomarkers
Blood, and urine, proteomic signatures of aging, including Interleukin-6, Tumor Necrosis Factor Alpha, Tissue Inhibitor of Metallo Proteinases-2, Transforming Growth Factor-Beta, and Mechanistic Target of Rapamycin (mTOR) levels, that are associated with various cellular, genetic and physiological mechanisms of aging will be measured at Baseline, 1,2,3,4,5,6, and 9 months.
Time frame: Baseline,1,2,3,4,5,6, and 9 months.
Plan to share: No
This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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