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

Sponsor
Andrews Research & Education Foundation (Other)
Overall Status
Recruiting
CT.gov ID
NCT05573386
Collaborator
Florida (Other)
10
1
23.9
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Anticipated Enrollment :
10 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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
Actual Study Start Date :
Aug 9, 2021
Anticipated Primary Completion Date :
Aug 5, 2023
Anticipated Study Completion Date :
Aug 5, 2023

Arms and Interventions

Arm 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)
  • Outcome Measures

    Primary Outcome Measures

    1. Arthrex Angel system for PRP concentration [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.

    2. Arthrex Angel system for PRP concentration [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 39 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Andrews Research and Education Foundation Gulf Breeze Florida United States 32561

    Sponsors and Collaborators

    • Andrews Research & Education Foundation
    • Florida

    Investigators

    • Principal Investigator: Adam Anz, MD, Orthopedic Surgeon

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Andrews Research & Education Foundation
    ClinicalTrials.gov Identifier:
    NCT05573386
    Other Study ID Numbers:
    • MPRP
    First Posted:
    Oct 10, 2022
    Last Update Posted:
    Oct 10, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 10, 2022