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FrailtyPhase 1/2NCT03458429

Safety, Efficacy of FFP From Healthy Donors to Ameliorate Frailty and Enhance Immune Function in Older Individuals

A Phase 1/2 study testing GMFFP in people with Frailty, run by Dipnarine Maharaj at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

1. 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… Read more about this study

Who is it for?
Ages 55 to 95 yearsHealthy volunteers can take part
Conditions the study is for
Frailty
What is being tested?
GMFFP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
5 Feb 2018to 30 Dec 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 95 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • South Florida Bone Marrow/Stem Cell Transplant Institute DBA Maharaj Institute of Immune Regenerative Medicine

    Boynton Beach, Florida, 33437

Other trials in United States

About this study

Official title: Safety and Efficacy of GMFFP From Young Healthy Donors (18-35), Treated With G-CSF to Ameliorate Frailty and Enhance the Immune Risk Profile in Older Individuals

  1. 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.
  2. Secondary Objective

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.

Read the detailed description

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).

Conditions
Frailty
Being tested
GMFFP
Keywords
Young Donor Plasma, Frailty, Aging, Immune Function, G-CSF
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GMFFPDrug

    Also called Granulocyte-Colony Stimulating Factor (G-CSF) Young Plasma

    Granulocyte-Colony Stimulating Factor (G-CSF) Mobilized Fresh Frozen Plasma

Study groups in NCT03458429
Study groupRoleWhat they receive
Frail, older subjectsExperimentalTreated 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.
Receives: Drug: GMFFP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24 months

Secondary outcomes (4)

  1. 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.

    Measured: 12 and 24 months

  2. 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.

    Measured: 12 and 24 months

  3. 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

    Measured: 12 and 24 months

  4. 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

    Measured: 12 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2018
  2. Study start5 Feb 2018
  3. Primary completion30 Dec 2029 (estimated)
  4. Study completion30 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03458429
Sponsor's protocol ID
001.16-BMSCTI
Status last verified
Apr 2026
First submitted
7 Feb 2018
Last updated
1 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GMFFP in people with Frailty, run by Dipnarine Maharaj at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment-related adverse events as assessed by clinical symptoms, laboratory abnormalities, serious adverse events and treatment-limiting adverse events (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03458429.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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