Reversing Epigenetic & Other Markers of Senescence by Transfusing Young Plasma To Older Human Subjects

Reversing Epigenetic & Other Markers of Senescence by Transfusing Young Plasma To Older Human Subjects

Sponsors

Lead Sponsor: Chandra Duggirala

Source Fountain Labs, Inc.
Brief Summary

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.

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.

Overall Status Not yet recruiting
Start Date May 15, 2018
Completion Date December 15, 2022
Primary Completion Date June 15, 2020
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Biological age as assessed by DNA methylation levels, to calculate the Epigenetic age. Baseline to end of Month 9.
Secondary Outcome
Measure Time Frame
Mental (Cognitive) Function Baseline and Month 9
Lung (Pulmonary) Function Baseline and Month 9
Kidney (Renal) Function Baseline and Month 9
Muscle Strength Baseline and Month 9
Telomere Length Baseline and Month 9
Testosterone Baseline and Month 9
Estrogen Baseline and Month 9
DHEAS Baseline and Month 9
IGF-1 Baseline and Month 9
High Sensitivity C-Reactive Protein Baseline and Month 9
P16INK4a (A marker of cellular aging) Baseline and Month 9
Enrollment 2120
Condition
Intervention

Intervention Type: Biological

Intervention Name: Plasma Transfusion

Description: 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.

Arm Group Label: Plasma Transfusion

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 40 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Chandra s duggirala Principal Investigator Fountain Labs, Inc.
Overall Contact

Last Name: Chandra s Duggirala, MBBS, MD

Phone: 815-793-1273

Email: [email protected]

Location
Facility: Contact: Contact Backup: The Infusion Center & Clinic Janeen Bc 650-348-6011
Location Countries

United States

Verification Date

January 2018

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Fountain Labs, Inc.

Investigator Full Name: Chandra Duggirala

Investigator Title: Principal Investigator

Has Expanded Access No
Number Of Arms 1
Arm Group

Label: Plasma Transfusion

Type: Experimental

Description: Plasma Transfusions with 2 units of plasma per dose, for a total of 6 doses

Acronym RESET-YOUTH
Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov