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

Frailty Clinical Trial

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

Status Enrolling by invitation

Clinical 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 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Frailty

• NCT number: NCT03458429
• Study type: Interventional
• Source: South Florida Bone Marrow/Stem Cell Transplant Institute
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• Start date: February 5, 2018
• Completion date: December 30, 2027