Reversing Epigenetic & Other Markers of Senescence by Transfusing Young Plasma To Older Human Subjects (RESET-YOUTH)
|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.|
|ClinicalTrials.gov Identifier: NCT03353597|
Recruitment Status : Not yet recruiting
First Posted : November 27, 2017
Last Update Posted : January 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Aging||Biological: Plasma Transfusion||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reversing Epigenetic & Other Markers of Senescence by Transfusing Young Plasma To Older Human Subjects|
|Estimated Study Start Date :||May 15, 2018|
|Estimated Primary Completion Date :||June 15, 2020|
|Estimated Study Completion Date :||December 15, 2022|
Experimental: Plasma Transfusion
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. [ Time Frame: Baseline to end of Month 9. ]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.
- Mental (Cognitive) Function [ Time Frame: Baseline and Month 9 ]Executive functioning, as measured by the California Stroop test
- Lung (Pulmonary) Function [ Time Frame: Baseline and Month 9 ]FEV1 (Forced Expiratory Volume during the first second), and Peak Expiratory Flow
- Kidney (Renal) Function [ Time Frame: Baseline and Month 9 ]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.
- Muscle Strength [ Time Frame: Baseline and Month 9 ]Unilateral Maximal Voluntary Isometric and Concentric Strength
- Telomere Length [ Time Frame: Baseline and Month 9 ]
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.
- Testosterone [ Time Frame: Baseline and Month 9 ]Serum free and total Testosterone levels
- Estrogen [ Time Frame: Baseline and Month 9 ]Serum Estrogen levels
- DHEAS [ Time Frame: Baseline and Month 9 ]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
- IGF-1 [ Time Frame: Baseline and Month 9 ]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.
- High Sensitivity C-Reactive Protein [ Time Frame: Baseline and Month 9 ]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.
- P16INK4a (A marker of cellular aging) [ Time Frame: Baseline and Month 9 ]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.
- Exploratory biomarkers [ Time Frame: Baseline,1,2,3,4,5,6, and 9 months. ]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.
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): NCT03353597
|Contact: Chandra s Duggirala, MBBS, MDemail@example.com|
|Contact: Chandra S Duggiralafirstname.lastname@example.org|
|United States, California|
|The Infusion Center & Clinic|
|San Mateo, California, United States, 94401|
|Contact: Janeen Bc 650-348-6011|
|Principal Investigator:||Chandra s duggirala||Fountain Labs, Inc.|