Reversing Epigenetic & Other Markers of Senescence by Transfusing Young Plasma To Older Human Subjects (RESET-YOUTH)

January 14, 2018 updated by: Chandra Duggirala
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

2120

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chandra s Duggirala, MBBS, MD
  • Phone Number: 815-793-1273
  • Email: cduggi@gmail.com

Study Contact Backup

Study Locations

  • United States
    • California
      • San Mateo, California, United States, 94401
        • The Infusion Center & Clinic
        • Contact:
          • Janeen Bc
          • Phone Number: 650-348-6011

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 40.
  • Stable medications for 2 months prior to Screening.
  • Signed and dated written informed consent obtained from the subject in accordance with local Institutional Review Board regulations.
  • Males and all Women of Child Bearing Potential agree to abstain from sex or use an adequate method of contraception for the duration of the study and for 30 days after the last dose of study drug. Adequate contraceptive methods include those with a low failure rate, i.e., less than 1% per year, when used consistently and correctly), and , a woman who has been surgically sterilized or who has been in a state of amenorrhea.

Exclusion Criteria:

  • Dementia of any etiology.
  • Any medical condition other than dementia that could account for cognitive deficits (e.g., active seizure disorder, stroke, Central Nervous System diseases);
  • History of significant cardiovascular, hematologic, renal, or advanced hepatic disease (or laboratory evidence thereof);
  • History of major psychiatric illness or untreated depression;
  • Neutrophil count <1,500/mm3, platelets <100,000/mm3, serum creatinine >1.5x upper limit of normal (ULN), total bilirubin >1.5 x ULN, Alanine Transaminase >3 x ULN, Aspartate Transaminase >3 x ULN, or International Normalized Ratio (INR) >1.2 at Screening evaluations;
  • Evidence of any clinically significant findings on Screening or baseline evaluations which, in the opinion of the Investigator would pose a safety risk or interfere with appropriate interpretation of study data;
  • Current or recent history (within four weeks prior to Screening) of a clinically significant bacterial, fungal, or mycobacterial infection;
  • Current clinically significant viral infection;
  • Major surgery within four weeks prior to Screening;
  • Any contraindication to monthly plasma transfusions, including but not limited to:
  • History of significant transfusion complications;
  • Compatible plasma units not available;
  • Prior intolerance to intravenous (IV) fluids;
  • Immunoglobulin A deficiency by history or laboratory evidence at Screening;
  • Bleeding;
  • Any concurrent use of an anti-coagulant therapy.
  • Daily administration of Aspirin 81mg will be allowed as long as the dose is stable for 30 days prior to Screening. Anti-platelet drugs are acceptable.
  • Treatment with another investigational drug or participation in another interventional clinical trial within 3 months of Screening;
  • Treatment with any human blood product, including IV immunoglobulin, during the 6 months prior to Screening or during the trial;
  • Pregnant or lactating;
  • Positive pregnancy test at Screening or Baseline (Day 1);
  • Cancer within 5 years of Screening, except for nonmetastatic skin cancer or non-metastatic prostate cancer not expected to cause significant morbidity or mortality within one year of Baseline.
  • AB blood type.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to end of Month 9.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mental (Cognitive) Function
Time Frame: Baseline and Month 9
Executive functioning, as measured by the California Stroop test
Baseline and Month 9
Lung (Pulmonary) Function
Time Frame: Baseline and Month 9
FEV1 (Forced Expiratory Volume during the first second), and Peak Expiratory Flow
Baseline and Month 9
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.
Baseline and Month 9
Muscle Strength
Time Frame: Baseline and Month 9
Unilateral Maximal Voluntary Isometric and Concentric Strength
Baseline and Month 9
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.
Baseline and Month 9
Testosterone
Time Frame: Baseline and Month 9
Serum free and total Testosterone levels
Baseline and Month 9
Estrogen
Time Frame: Baseline and Month 9
Serum Estrogen levels
Baseline and Month 9
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
Baseline and Month 9
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.
Baseline and Month 9
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.
Baseline and Month 9
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.
Baseline and Month 9

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline,1,2,3,4,5,6, and 9 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chandra Duggirala

Investigators

  • Principal Investigator: Chandra s duggirala, Fountain Labs, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 15, 2018

Primary Completion (ANTICIPATED)

June 15, 2020

Study Completion (ANTICIPATED)

December 15, 2022

Study Registration Dates

First Submitted

November 7, 2017

First Submitted That Met QC Criteria

November 21, 2017

First Posted (ACTUAL)

November 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 17, 2018

Last Update Submitted That Met QC Criteria

January 14, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • FFP-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aging

Clinical Trials on Plasma Transfusion

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe