Status:
UNKNOWN
Reversing Epigenetic & Other Markers of Senescence by Transfusing Young Plasma To Older Human Subjects
Lead Sponsor:
Chandra Duggirala
Conditions:
Aging
Eligibility:
All Genders
40+ years
Phase:
PHASE1
PHASE2
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 pul...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2022
Estimated Enrollment :
2120 Patients enrolled
Trial Details
Trial ID
NCT03353597
Start Date
May 15 2018
End Date
December 15 2022
Last Update
January 17 2018
Active Locations (1)
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1
The Infusion Center & Clinic
San Mateo, California, United States, 94401