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

August 11, 2025 updated by: Andrews Research & Education Foundation

A Single Center, Prospective Study to Compare the Quality and Quantity of the Cellular Content of M-PRP Harvested After Peripheral Mobilization of Progenitor Cells Using Filgrastim Versus Pegfilgrastim

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The proposed study is a prospective, randomized controlled, single-center laboratory study involving 10 healthy volunteers. Once the potential participant has cleared the screening, consented to the study procedures, completed the medical interview, and laboratory blood testing, the subject will undergo two serial mobilization events. The scheduling of the mobilization events will be varied across the 10 participants to counter sequencing effects of the mobilization events. 5 healthy donors will be administered standard filgrastim mobilization regimen of 10 mcg/kg per day for 4 days. This will be followed by a standard pegfilgrastim mobilization regimen consisting of one 6 mg injection separated by 8 weeks for 5 of the participants. The other 5 healthy donors will receive the reverse order of the pharmaceutical agent, first pegfilgrastim followed by filgrastim.

On the first day of the study, a first blood draw of 130 mL will be performed which will be used to create standard PRP for laboratory testing and subjects will begin a filgrastim or pegfilgrastim dosage series. After the specified time (4 days for filgrastim and 7 days for pegfilgrastim), a second 130 mL of blood will be harvested and processed with the Arthrex Angel system to create M-PRP for laboratory testing. The standard PRP and M-PRP cellular content will be studied and quantified in vitro with cell counting, cell culturing and protein analysis. 8 weeks after the second blood harvest, the subjects will return for a third 130 mL of blood draw, followed by administration of a second mobilizing agent (pegfilgrastim or filgrastim). After the specified time (4 days for filgrastim and 7 days for pegfilgrastim), the patients will return for a fourth blood draw of 130mL. The sample will be processed with the Arthrex Angel system to create M-PRP for laboratory testing. The cellular content of the M-PRP product will be studied and quantified in vitro with cell counting, cell culturing and protein analysis. Thereafter, the cellular content of M-PRP product will be compared between filgrastim and pegfilgrastim mobilization agents.

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gulf Breeze, Florida, United States, 32561
        • Andrews Research and Education Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Filgrastim to Pegfilgrastim
Participants in this group will receive filgrastim treatment, followed by pegfilgrastim treatment at the 8-week mark.
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
Other Names:
  • Granix (tbo-filgrastim)
Drug: Pegfilgrastim
long-acting covalent conjugate of recombinant methionyl human filgrastim and monomethoxypolyethylene glycol (PEG); administered via syringe
Other Names:
  • Fulphila (pegfilgrastim-imdb)
Pegfilgrastim to filgrastim
Participants in this group will receive pegfilgrastim treatment, followed by filgrastim treatment at the 8-week mark
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
Other Names:
  • Granix (tbo-filgrastim)
Drug: Pegfilgrastim
long-acting covalent conjugate of recombinant methionyl human filgrastim and monomethoxypolyethylene glycol (PEG); administered via syringe
Other Names:
  • Fulphila (pegfilgrastim-imdb)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arthrex Angel System for PRP Concentration
Time Frame: at time of enrollment
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
Time Frame: 8 weeks from enrollment, upon switch in treatment from filgrastim/pegfilgrastim
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andrews Research & Education Foundation

Collaborators

Florida

Investigators

  • Principal Investigator: Adam Anz, MD, Orthopedic Surgeon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2021

Primary Completion (Actual)

August 5, 2023

Study Completion (Actual)

October 5, 2023

Study Registration Dates

First Submitted

October 3, 2022

First Submitted That Met QC Criteria

October 6, 2022

First Posted (Actual)

October 10, 2022

Study Record Updates

Last Update Posted (Estimated)

August 28, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MPRP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Filgrastim

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe