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Comparison of Quality and Quantity of M-PRP Cellular Content Filgrastim vs. Pegfilgrastim

NCT05573386 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2025-08-28

Study results available
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Summary

The goal of this prospective, observational study is to compare the quality and quantity of the cellular content of platelet-rich plasma harvested after administering one of two cell-stimulating proteins, filgrastim and pegfilgrastim. The main question it aims to answer is:

• Will participants have a similar cellular content when comparing a 4-day filgrastim treatment to a one-day pegfilgrastim treatment?

Participants will have the following intervention administered:

* 130mL of blood will be drawn on the first visit after consent and in followup visits after administering treatment (4 days for filgrastim, 7 days for pegfilgrastim)
* Half of all participants will receive filgrastim first, followed by pegfilgrastim 8 weeks after filgrastim treatment concludes. The other half will receive the treatments in reverse order

Researchers will compare the quality and quantity of cell content after each treatment administration as well as comparing differences in data dependent on which order treatment was given.

Conditions

  • Healthy

Interventions

DRUG

Filgrastim

human granulocyte colony-stimulating factor (G-CSF) protein obtained from the bacterial fermentation of a strain of E. coli. transformed with a genetically engineered plasmid containing the human G-CSF gene; administered via syringe

DRUG

Pegfilgrastim

long-acting covalent conjugate of recombinant methionyl human filgrastim and monomethoxypolyethylene glycol (PEG); administered via syringe

Sponsors & Collaborators

  • Florida

    collaborator OTHER

  • Andrews Research & Education Foundation

    lead OTHER

Principal Investigators

  • Adam Anz, MD · Orthopedic Surgeon

Eligibility

Min Age
19 Years
Max Age
39 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-09
Primary Completion
2023-08-05
Completion
2023-10-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05573386 on ClinicalTrials.gov