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

NCT05573386 | Completed Results FDA Drug

• 1 other identifier: MPRP
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Arthrex Angel System for PRP Concentration

  Machine utilizing centrifugation and optics to precisely separate cell types using buffy coat method. . All cells have a density range and non-uniformly after centrifugation. Arthrex Angel system has the unique ability to isolate specific cells using inherent properties of cells that absorb differing wavelengths of light. The settings on the system can be controlled to adjust the proportion of cells versus plasma. Increasing the setting from 7% to 15%, the Angel system isolates more cells from a deeper portion of the buffy coat, which results in capturing more HPCs per volume.

  at time of enrollment

• Arthrex Angel System for PRP Concentration

  Machine utilizing centrifugation and optics to precisely separate cell types using buffy coat method. . All cells have a density range and non-uniformly after centrifugation. Arthrex Angel system has the unique ability to isolate specific cells using inherent properties of cells that absorb differing wavelengths of light. The settings on the system can be controlled to adjust the proportion of cells versus plasma. Increasing the setting from 7% to 15%, the Angel system isolates more cells from a deeper portion of the buffy coat, which results in capturing more HPCs per volume.

  8 weeks from enrollment, upon switch in treatment from filgrastim/pegfilgrastim

Study Arms (2)

Filgrastim to Pegfilgrastim

Participants in this group will receive filgrastim treatment, followed by pegfilgrastim treatment at the 8-week mark.

Drug: Filgrastim; Drug: Pegfilgrastim

Pegfilgrastim to filgrastim

Participants in this group will receive pegfilgrastim treatment, followed by filgrastim treatment at the 8-week mark

Drug: Filgrastim; Drug: Pegfilgrastim

Interventions

Filgrastim DRUG

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

Also known as: Granix (tbo-filgrastim)

Filgrastim to Pegfilgrastim; Pegfilgrastim to filgrastim

Pegfilgrastim DRUG

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

Also known as: Fulphila (pegfilgrastim-imdb)

Filgrastim to Pegfilgrastim; Pegfilgrastim to filgrastim

Eligibility Criteria

• Age: 19 Years - 39 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy, male, college to adult aged males weighing between 50 and 100kg are the focus demographic of this study

You may qualify if:

• Healthy 19-39 of age and weight 50-100kg
• Subject consents to coming 5 serial days for filgrastim treatment and additional blood draw, 8 weeks later two additional visits for pegfilgrastim treatment and blood draw 7 days later. This order of administration will be provided to half of the participants, where as the other half will receive the same treatments in reverse order.

You may not qualify if:

• Female
• Weight \< 50kg or \> 100kg
• Previous allergic reaction to filgrastim, PEG, lidocaine, latex, acrylic, or any other injectable numbing agent
• History of Diabetes
• Abdominal tenderness to palpation
• Unclear lung fields on physical exam
• Splenomegaly
• Significant cardiovascular, renal, hepatic, or pulmonary disease
• White blood cell count (WBC) over 20,000/microliter (mcL) upon initial complete blood count (CBC) screening
• Blood disorders, autoimmune disorders, disorders requiring immunosuppression, cancer, an ongoing infectious disease, sickle cell, or other blood disorders.

Sponsors & Collaborators

• Andrews Research & Education Foundation: lead
• Florida: collaborator

Study Sites (1)

Andrews Research and Education Foundation

Gulf Breeze, Florida, 32561, United States

Location

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Biospecimen

Retention: SAMPLES WITH DNA

Platelet-Rich Plasma (PRP) samples extracted from participants

MeSH Terms

Interventions

Filgrastim; pegfilgrastim

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Director of Research
• Organization: Andrews Research & Education Foundation

jessica.truett@andrewsref.org

8509168570

Study Officials

• Adam Anz, MD

  Orthopedic Surgeon

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 10, 2022
• Study Start: August 9, 2021
• Primary Completion: August 5, 2023
• Study Completion: October 5, 2023
• Last Updated: August 28, 2025
• Results First Posted: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)