A Phase 1/2 interventional study of GMFFP in Frailty, sponsored by Dipnarine Maharaj. Enrolling by invitation at 1 site in United States. Open to participants aged 55 Years to 95 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by Dipnarine Maharaj · Phase 1/2, Interventional, and Treatment
Among 185 studies in Frailty with a site in United States — 50 open to participants now, 62 under way, 1 of them phase 3. Frailty · United States.
Among the 185 studies in Frailty with a site in United States, this one is the 89th largest by planned enrollment of the 142 interventional ones that give a count, is one of 19 that started in 2018, is one of 8 in phase 1/2, reaches primary completion later than 53 of the 60 other live ones, and was the 56th registered.
1,284 studies on the registry are indexed under Frailty; 451 are open to participants now.
Browse Frailty studies →50 of the 185 studies in Frailty with a site in United States are open now. Recruiting first, the newest first:
University of Maryland, Baltimore · Sites in United States
Ages 55+
University of California, San Francisco · Sites in United States
Ages 18–75
Longevity Metrics, Inc. · Sites in United States
Ages 18+ · Healthy volunteers
William Brandenburg, MD · Sites in United States
Ages 18+ · Healthy volunteers
Longevity Metrics, Inc. · Sites in United States
Ages 18+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 299 Frailty studies recruiting now, 235 (79%) set no upper age limit and 9 (3%) stop at 75 or younger; 7 take children under 18; 66 take healthy volunteers.
This study: 55 Years to 95 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
185 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 16 · Phase 2 32 · Phase 3 5 · Phase 4 5
First in 2001; this study’s year is marked. 19 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 81 across 767 interventional studies indexed under Frailty.
Median enrollment 42 across the 142 interventional studies, 128 across the 42 observational. Of the 112 that completed or were terminated, 42 (38%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 185 have an industry lead sponsor. The 10 most frequent:
Dipnarine Maharaj is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Dipnarine Maharaj has 1 study filed under Frailty — fewer than ten, so there is no comparison to draw.
24 of the studies in Frailty with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05422534Phase 3Vanderbilt University Medical CenterCoQ10 and Exercise for Mitochondrial Dysfunction in Advance Kidney Disease | 2027-06-20 |
| NCT03675724Mayo ClinicAlleviation by Fisetin of Frailty, Inflammation, and Related Measures in Older Adults | 2026-11 |
| NCT03430037Mayo ClinicAlleviation by Fisetin of Frailty, Inflammation, and Related Measures in Older Women | 2026-11 |
| NCT07220512Wake Forest University Health SciencesThe Better, Harder, Faster, Stronger Study | 2026-11 |
| NCT05725928The Cleveland ClinicAssisted Ambulation to Improve Health Outcomes for Older Medical Inpatients | 2026-11-30 |
Add all 24 to your calendar (.ics) → With an account.
Among the 185 studies in Frailty with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Primary Objective
To determine the safety and tolerability of 12 once monthly transfusions of GMFFP (Granulocyte - Colony Stimulating Factor (G-CSF) Mobilized Fresh Frozen Plasma harvested from young, healthy donors), given to older, frail individuals who are at risk due to unhealthy aging and who will then have a subsequent 12-month follow-up period.
To determine the efficacy in older, frail individuals of 12 once monthly transfusions of GMFFP (Granulocyte - Colony Stimulating Factor (G-CSF) Mobilized Fresh Frozen Plasma harvested from young, healthy donors), and a subsequent 12-month follow-up period, to improve the Immune Risk Profile, ("IRP"), cognitive function (MME), quality of life (OPQOL-35), Frailty Index ("FI"), associated with unhealthy aging in the treated subjects.
There have been recent reports in medical literature about the discovery that young mice's blood plasma when infused into aged mice caused regeneration of organs such as liver, and brain. There are certain factors present in the young blood which have been shown to improve the function of the organs.
In humans, transferring of young blood plasma to treat the effect of aging has already been attempted by a few doctors. In addition, fresh frozen blood plasma is currently used to treat patients who have disorders of blood clotting and immune disorders and is regarded as the standard of care by the medical community and as a safe treatment.
Over the past 25 years, peripheral blood stem cells (PBSC) concentrates have replaced bone marrow as the source for autologous stem cell transplants. Each year approximately 20,000 healthy individuals receive a protein call Granulocyte Colony Stimulating Factor (G-CSF) in order to stimulate and release stem cells from the bone marrow into the peripheral blood and these stem cells are collected and reinfused into patients who have blood cancers and other immune disorders. Granulocyte Colony Stimulating Factor (G-CSF) has been approved by the FDA for mobilization of the stem cells and collection of an individual's own stem cells. In a standard peripheral blood stem cell transplant the stem cells as well as the plasma are collected from the donor and is reinfused into the patient for treatment. There are recent reports in the medical literature that mobilized stem cells secrete certain factors into the plasma of the blood and that these factors may be important for the regenerative capabilities of stem cells.
The transfusion of the plasma which contains these factors, secreted by the stem cells, which come from young individuals and are free of stem cells, may be an effective treatment for frailty and immune dysfunction in older individuals.
In this study, the treatment is considered experimental (investigational) because we are evaluating the safety and effectiveness of healthy donor plasma which contains the factors secreted by stem cells for the treatment of frailty and immune dysfunction. The plan of this study is to enroll about 30 subjects for treatment and follow up evaluation over a time period of two years (24 months).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
greater than 10.0 g/dl Absolute neutrophils must be greater than 1,500/Microliter(uL) count must be greater than100,000/uL Serum must be less than 2mg/dL (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:
count less than 100,000/mm3 Absolute neutrophils less than 1500/uL less than 10 g/dL , alanine transaminase, or alkaline phosphatase Greater than 3 times Serum greater than 2 mg/dL
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 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.
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treated subjects are the frail, older subjects who will be treated with Granulocyte-Colony Stimulating Factor (G-CSF) Mobilized Fresh Frozen Plasma (GMFFP) in this protocol.
Drug: GMFFP
Granulocyte-Colony Stimulating Factor (G-CSF) Mobilized Fresh Frozen Plasma
Also known as: Granulocyte-Colony Stimulating Factor (G-CSF) Young Plasma
Number of participants with treatment-related adverse events as assessed by clinical symptoms, laboratory abnormalities, serious adverse events and treatment-limiting adverse events
To determine the safety and tolerability of 12 once monthly transfusions of GMFFP (Granulocyte - Colony Stimulating Factor (G-CSF) Mobilized Fresh Frozen Plasma harvested from young, healthy donors) given to older, frail individuals who are at risk due to unhealthy aging and who will be assessed throughout the duration of treatment. After the one-year treatment period, participants will complete follow-up assessments every 3 months for 1 year.
Time frame: 24 months
Efficacy outcomes as measured by changes from baseline at 12 and 24 months assessing Immune Risk Profile (IRP)
To determine the efficacy in older, frail individuals of 12 once monthly transfusions of GMFFP (Granulocyte - Colony Stimulating Factor (G-CSF) Mobilized Fresh Frozen Plasma harvested from young, healthy donors), and a subsequent 12-month follow-up period, to improve the Immune Risk Profile (IRP) as assessed by aging, inflammation and immune function biomarkers.
Time frame: 12 and 24 months
Efficacy outcomes as measured by changes from baseline at 12 and 24 months assessing cognitive function (MME)
To determine the efficacy in older, frail individuals of 12 once monthly transfusions of GMFFP (Granulocyte - Colony Stimulating Factor (G-CSF) Mobilized Fresh Frozen Plasma harvested from young, healthy donors), and a subsequent 12-month follow-up period, to improve cognitive function (MME) as assessed by cognitive impairment and to follow the course of cognitive changes in an individual over time. The test examines functions, including registration, attention and calculation, recall, language, ability to follow simple commands, and orientation.
Time frame: 12 and 24 months
Efficacy outcomes as measured by changes from baseline at 12 and 24 months assessing quality of life (OPQOL-35)
To determine the efficacy in older, frail individuals of 12 once monthly transfusions of GMFFP (Granulocyte - Colony Stimulating Factor (G-CSF) Mobilized Fresh Frozen Plasma harvested from young, healthy donors), and a subsequent 12-month follow-up period, to improve quality of life (OPQOL-35) assessed by the effect of health, social relationships, independence, psychological well-being, and activities on overall quality of life in older individuals
Time frame: 12 and 24 months
Efficacy outcomes as measured by changes from baseline at 12 and 24 months assessing Frailty Index (FI)
To determine the efficacy in older, frail individuals of 12 once monthly transfusions of GMFFP (Granulocyte - Colony Stimulating Factor (G-CSF) Mobilized Fresh Frozen Plasma harvested from young, healthy donors), and a subsequent 12-month follow-up period, to improve Frailty Index ("FI"), as measured by eight frailty factors including nutritional status, physical activity, mobility, energy, strength, cognition, mood, and social support
Time frame: 12 and 24 months
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2018 (actual). Primary completion is estimated for Dec 2029, 142 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Dipnarine Maharaj