Comparison of Quality and Quantity of M-PRP Cellular Content Filgrastim vs. Pegfilgrastim
NCT ID: NCT05573386
Last Updated: 2025-08-28
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Total Enrollment
15 participants
Study Classification
OBSERVATIONAL
Study Start Date
2021-08-09
Study Completion Date
2023-10-05
Brief Summary
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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.
• 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.
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Detailed Description
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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.
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.
Conditions
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Healthy
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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Filgrastim to Pegfilgrastim
Participants in this group will receive filgrastim treatment, followed by pegfilgrastim treatment at the 8-week mark.
Filgrastim
Intervention Type
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
Pegfilgrastim
Intervention Type
DRUG
long-acting covalent conjugate of recombinant methionyl human filgrastim and monomethoxypolyethylene glycol (PEG); administered via syringe
Pegfilgrastim to filgrastim
Participants in this group will receive pegfilgrastim treatment, followed by filgrastim treatment at the 8-week mark
Filgrastim
Intervention Type
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
Pegfilgrastim
Intervention Type
DRUG
long-acting covalent conjugate of recombinant methionyl human filgrastim and monomethoxypolyethylene glycol (PEG); administered via syringe
Interventions
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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
Intervention Type
DRUG
Pegfilgrastim
long-acting covalent conjugate of recombinant methionyl human filgrastim and monomethoxypolyethylene glycol (PEG); administered via syringe
Intervention Type
DRUG
Other Intervention Names
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Granix (tbo-filgrastim)
Fulphila (pegfilgrastim-imdb)
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
19 Years
Maximum Eligible Age
39 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
Yes
Sponsors
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Florida
OTHER
Sponsor Role
collaborator
Andrews Research & Education Foundation
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Adam Anz, MD
Role: PRINCIPAL_INVESTIGATOR
Orthopedic Surgeon
Locations
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Andrews Research and Education Foundation
Gulf Breeze, Florida, United States
Site Status
Countries
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United States
References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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MPRP
Identifier Type: -
Identifier Source: org_study_id
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