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

NCT03353597 | Unknown Phase 1 FDA Drug

• 1 other identifier: FFP-1
• Study Type: interventional
• Target: 2,120
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to end of Month 9.

Secondary Outcomes (11)

• 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

Other Outcomes (1)

• Exploratory biomarkers

  Baseline,1,2,3,4,5,6, and 9 months.

Study Arms (1)

Plasma Transfusion

EXPERIMENTAL

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

Biological: Plasma Transfusion

Interventions

Plasma Transfusion BIOLOGICAL

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.

Plasma Transfusion

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Chandra Duggirala: lead

Study Sites (1)

The Infusion Center & Clinic

San Mateo, California, 94401, United States

Location

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Study Officials

• Chandra s duggirala

  Fountain Labs, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chandra s Duggirala, MBBS, MD

CONTACT

815-793-1273; cduggi@gmail.com

Chandra S Duggirala

CONTACT

9252334334; cduggi@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: November 27, 2017
• Study Start: May 15, 2018
• Primary Completion: June 15, 2020
• Study Completion: December 15, 2022
• Last Updated: January 17, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)