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GMFFP

Phase 1

Frailty | Small molecule | Other |Bone Biologics Corp|Last Updated: May 1, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

GMFFP · 1 trial · 1 indication

Phase 1 1
NCT03458429Safety, Efficacy of FFP From Healthy Donors to Ameliorate Frailty and Enhance Immune Function in Older IndividualsFrailty
ENROLLING BY_INVITATION30 Analytics
PHASE1ENROLLING BY_INVITATION
Safety, Efficacy of FFP From Healthy Donors to Ameliorate Frailty and Enhance Immune Function in Older Individuals
Frailty
NCT0345842930
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Study Endpoints

Primary Endpoints

Number of participants with treatment-related adverse events as assessed by clinical symptoms, laboratory abnormalities, serious adverse events and treatment-limiting adverse events
24 months

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.

Secondary Endpoints

Efficacy outcomes as measured by changes from baseline at 12 and 24 months assessing Immune Risk Profile (IRP)
12 and 24 months
Efficacy outcomes as measured by changes from baseline at 12 and 24 months assessing cognitive function (MME)
12 and 24 months
Efficacy outcomes as measured by changes from baseline at 12 and 24 months assessing quality of life (OPQOL-35)
12 and 24 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
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.

Interventions

NameTypeDescription
GMFFPDRUGGranulocyte-Colony Stimulating Factor (G-CSF) Mobilized Fresh Frozen Plasma
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Eligibility Criteria

Age Range55 Years to 95 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
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Frequently asked questions about GMFFP

What is GMFFP used for?

GMFFP is an investigational small molecule being developed for frailty in older individuals. It is currently in Phase 1 clinical development and is not approved by the FDA. The drug is being studied to assess its safety and efficacy in ameliorating frailty and enhancing immune function in older individuals.

Who makes GMFFP?

GMFFP is being developed by Bone Biologics Corp, a company traded on the stock exchange under the ticker symbol BBLG. The company is conducting a Phase 1 clinical trial to evaluate the drug's safety and efficacy in older individuals with frailty.

What phase is GMFFP in?

GMFFP is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is enrolling participants by invitation and is designed to evaluate the safety and efficacy of GMFFP in older individuals with frailty.

What clinical trials is GMFFP in?

GMFFP is being studied in a Phase 1 clinical trial with the identifier NCT03458429. The trial is titled 'Safety, Efficacy of FFP From Healthy Donors to Ameliorate Frailty and Enhance Immune Function in Older Individuals' and is enrolling 30 participants in the United States. The study is enrolling by invitation and includes healthy volunteers aged 55 years and older.

Is GMFFP the same as FFP?

GMFFP is also referred to as FFP in clinical trial documentation. The Phase 1 trial NCT03458429 uses the title 'Safety, Efficacy of FFP From Healthy Donors to Ameliorate Frailty and Enhance Immune Function in Older Individuals,' indicating that FFP is the alternative name for GMFFP.