Can young blood reverse aging? new trial tests monthly plasma transfusions
NCT ID NCT03458429
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether monthly transfusions of plasma from young, healthy donors can safely reduce frailty and improve immune function in older adults aged 55-95. Thirty participants will receive 12 transfusions over a year and be followed for another year. The goal is to see if this approach can improve quality of life, thinking skills, and overall health.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Plasma from young donors treated with G-CSF
- What this could lead to
- If it works, this could point toward a treatment that reduces frailty and strengthens the immune system in older people.
- What could go wrong
- This is an early-phase trial with only 30 participants, so results may not apply widely. There are also risks from monthly transfusions, such as allergic reactions or infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2018
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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55 to 95 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Provide written informed consent. * Be aged between 55-95 years. * Show signs of frailty apart from a concomitant condition as assessed by the Investigator with a score of 4-7 on the Clinical Frailty Scale (Appendix 1) and/or Have an abnormal Immune Risk Profile (IRP) * Not be pregnant or nursing while participating in this trial. Both men and women of reproductive potential must agree to use an effective means of birth control while participating in the trial. Women of childbearing potential should have a negative serum pregnancy test before treatment, if not surgically sterile. * Have a negative neutrophil antibody test. * Have a negative Human Leukocyte Antigen (HLA) Class I and II antibody test. * Have Cytomegalovirus (CMV) negative or positive sero-testing completed. * Have a life expectancy of at least 24 months as judged by the PI at the time of consent. * Have less than 4 weeks since prior medical therapy, radiation therapy, and/or surgery * Have adequate organ function including: Hemoglobin greater than 10.0 g/dl Absolute neutrophils must be greater than 1,500/Microliter(uL) Platelet count must be greater than100,000/uL Serum bilirubin must be less than 2mg/dL Aspartate Aminotransferase (AST) must be less than 90 units/L Alanine Transaminase (ALT) must be less than 105 units/L Serum creatinine must be less than 2mg/dL Exclusion Criteria: * Have a score of less than 4 or greater than 7 on the Clinical Frailty Scale or Have a score of less than 4 and a No Immune Risk Profile (IRP) * Have used anti-inflammatory medications within 7 days of study treatment,treated subjects may be re-screened after 14 days * Abnormal clinical values including but not limited to: Platelet count less than 100,000/mm3 Absolute neutrophils less than 1500/uL Hemoglobin less than 10 g/dL Aspartate transaminase, alanine transaminase, or alkaline phosphatase Greater than 3 times upper limit of normal Serum bilirubin greater than 2 mg/dL * Be an organ transplant recipient or have an active listing (or expected future listing) for transplant of any organ. * Have a documented intolerance to plasma or its components, or prior intolerance to intravenous fluids. * Have known serum antibodies to plasma proteins, such as haptoglobin, Complement Component (C3/C4), or alpha-1-antitrypsin. * Previous plasma transfusion within 30 days of signing informed consent. * Serious comorbid illness including, but not limited to: HIV or hepatitis Congenital deficiency of immunoglobulin A (IgA) Pulmonary edema Advanced liver or renal failure Uncontrolled diabetes mellitus, Significant and/or symptomatic cardiovascular disease (e.g. any history of myocardial infarction, congestive heart failure, unstable angina, uncontrolled arrhythmia) Active serious infection. Hemorrhagic cystitis Cardiac revascularization within last six months Severe obstructive ventilatory defect Renal insufficiency (serum creatinine greater than 177 mol/L or creatinine clearance less than 20 mL/min) Sickle cell disease or hemoglobinopathy Cancer Any other condition that the investigator believes may compromise the safety or compliance of the patient or the study evaluation. * No vascular access * Pregnant or nursing female * Recent ( less than 24 months) history of drug or alcohol abuse * Current participation in an investigational therapeutic or medical device trial * Treatment with any human blood product, including intravenous immunoglobulin, during the 6 months prior to screening or during the trial. * Recent use (within 30 days) of immunosuppressive agents * Inability to perform any assessments or relevant procedures required for the study or to give informed consent Although not considered a part of the formal eligibility criteria, the treating physicians will evaluate additional factors that may increase subject risk, including but not limited to: The presence of serious illnesses that would limit survival to less than two years. The presence of psychiatric conditions that would prevent compliance with study visits or impact informed consent. The presence of uncontrolled or severe cardiovascular disease, pulmonary disease, age-related or other serious medical conditions, or infection, which, in the opinion of the treating physician, would make study participation unreasonably hazardous.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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South Florida Bone Marrow/Stem Cell Transplant Institute DBA Maharaj Institute of Immune Regenerative Medicine
Boynton Beach, Florida, 33437, United States
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