Reversing Epigenetic & Other Markers of Senescence by Transfusing Young Plasma To Older Human Subjects
NCT ID: NCT03353597
Last Updated: 2018-01-17
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE1/PHASE2
Total Enrollment
2120 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-05-15
Study Completion Date
2022-12-15
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Aging
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Plasma Transfusion
Plasma Transfusions with 2 units of plasma per dose, for a total of 6 doses
Group Type
EXPERIMENTAL
Plasma Transfusion
Intervention Type
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.
Interventions
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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.
Intervention Type
BIOLOGICAL
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
40 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Chandra Duggirala
INDUSTRY
Sponsor Role
lead
Responsible Party
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Chandra Duggirala
Principal Investigator
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Chandra s duggirala
Role: PRINCIPAL_INVESTIGATOR
Fountain Labs, Inc.
Locations
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The Infusion Center & Clinic
San Mateo, California, United States
Site Status
Countries
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United States
Central Contacts
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Facility Contacts
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Janeen Bc
Role: primary
650-348-6011
S
Role: backup
References
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Reference Type
BACKGROUND
Teschendorff AE, Menon U, Gentry-Maharaj A, Ramus SJ, Weisenberger DJ, Shen H, Campan M, Noushmehr H, Bell CG, Maxwell AP, Savage DA, Mueller-Holzner E, Marth C, Kocjan G, Gayther SA, Jones A, Beck S, Wagner W, Laird PW, Jacobs IJ, Widschwendter M. Age-dependent DNA methylation of genes that are suppressed in stem cells is a hallmark of cancer. Genome Res. 2010 Apr;20(4):440-6. doi: 10.1101/gr.103606.109. Epub 2010 Mar 10.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FFP-1
Identifier Type: -
Identifier Source: org_study_id
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