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| Name | Class |
|---|---|
| Florida | OTHER |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Filgrastim to Pegfilgrastim | Participants in this group will receive filgrastim treatment, followed by pegfilgrastim treatment at the 8-week mark. |
| |
| Pegfilgrastim to filgrastim | Participants in this group will receive pegfilgrastim treatment, followed by filgrastim treatment at the 8-week mark |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy, male, college to adult aged males weighing between 50 and 100kg are the focus demographic of this study
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| Name | Affiliation | Role |
|---|---|---|
| Adam Anz, MD | Orthopedic Surgeon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andrews Research and Education Foundation | Gulf Breeze | Florida | 32561 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18679760 | Background | Mock C, Cherian MN. The global burden of musculoskeletal injuries: challenges and solutions. Clin Orthop Relat Res. 2008 Oct;466(10):2306-16. doi: 10.1007/s11999-008-0416-z. Epub 2008 Aug 5. | |
| 28144608 | Background | Akpancar S, Tatar O, Turgut H, Akyildiz F, Ekinci S. The Current Perspectives of Stem Cell Therapy in Orthopedic Surgery. Arch Trauma Res. 2016 Aug 16;5(4):e37976. doi: 10.5812/atr.37976. eCollection 2016 Dec. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Filgrastim Then Pegfilgrastim | Participants first received filgrastim treatment, followed by a washout period of 8 weeks. They then received pegfilgrastim treatment at the 8-week mark. |
| FG001 | Pegfilgrastim Then Filgrastim | Participants first received pegfilgrastim treatment, followed by a washout period of 8 weeks. They then received filgrastim treatment at the 8-week mark. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Filgrastim to Pegfilgrastim | Participants in this group will receive filgrastim treatment, followed by pegfilgrastim treatment at the 8-week mark. 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 Pegfilgrastim: long-acting covalent conjugate of recombinant methionyl human filgrastim and monomethoxypolyethylene glycol (PEG); administered via syringe |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | CD45+ cells/uL | at time of enrollment |
|
6 months
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Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Filgrastim to Pegfilgrastim | Participants who first received filgrastim treatment, followed by a washout period of 8 weeks. These participants then received pegfilgrastim treatment at the 8-week mark. |
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Research | Andrews Research & Education Foundation | 8509168570 | jessica.truett@andrewsref.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 20, 2022 | Feb 2, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 8, 2022 | Feb 2, 2024 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| C455861 | pegfilgrastim |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
Not provided
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Platelet-Rich Plasma (PRP) samples extracted from participants
|
| Pegfilgrastim | Drug | long-acting covalent conjugate of recombinant methionyl human filgrastim and monomethoxypolyethylene glycol (PEG); administered via syringe |
|
|
| 24046512 | Background | Hauser RA, Orlofsky A. Regenerative injection therapy with whole bone marrow aspirate for degenerative joint disease: a case series. Clin Med Insights Arthritis Musculoskelet Disord. 2013 Sep 4;6:65-72. doi: 10.4137/CMAMD.S10951. eCollection 2013. |
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| 26354202 | Background | Vangsness CT Jr, Sternberg H, Harris L. Umbilical Cord Tissue Offers the Greatest Number of Harvestable Mesenchymal Stem Cells for Research and Clinical Application: A Literature Review of Different Harvest Sites. Arthroscopy. 2015 Sep;31(9):1836-43. doi: 10.1016/j.arthro.2015.03.014. |
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| 28043750 | Background | Anz AW, Branch EA, Rodriguez J, Chillemi F, Bruce JR, Murphy MB, Suzuki RK, Andrews JR. Viable Stem Cells Are in the Injury Effusion Fluid and Arthroscopic Byproducts From Knee Cruciate Ligament Surgery: An In Vivo Analysis. Arthroscopy. 2017 Apr;33(4):790-797. doi: 10.1016/j.arthro.2016.09.036. Epub 2016 Dec 30. |
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| 32403148 | Background | Fang W, Sun Z, Chen X, Han B, Vangsness CT Jr. Synovial Fluid Mesenchymal Stem Cells for Knee Arthritis and Cartilage Defects: A Review of the Literature. J Knee Surg. 2021 Nov;34(13):1476-1485. doi: 10.1055/s-0040-1710366. Epub 2020 May 13. |
| 33010328 | Background | Branch EA, Matuska AM, Plummer HA, Harrison RM, Anz AW. Platelet-Rich Plasma Devices Can Be Used to Isolate Stem Cells From Synovial Fluid at the Point of Care. Arthroscopy. 2021 Mar;37(3):893-900. doi: 10.1016/j.arthro.2020.09.035. Epub 2020 Oct 1. |
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| 32118081 | Background | Anz AW, Hubbard R, Rendos NK, Everts PA, Andrews JR, Hackel JG. Bone Marrow Aspirate Concentrate Is Equivalent to Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis at 1 Year: A Prospective, Randomized Trial. Orthop J Sports Med. 2020 Feb 18;8(2):2325967119900958. doi: 10.1177/2325967119900958. eCollection 2020 Feb. |
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| 23758701 | Background | Siegel G, Kluba T, Hermanutz-Klein U, Bieback K, Northoff H, Schafer R. Phenotype, donor age and gender affect function of human bone marrow-derived mesenchymal stromal cells. BMC Med. 2013 Jun 11;11:146. doi: 10.1186/1741-7015-11-146. |
| BG001 | Pegfilgrastim to Filgrastim | Participants in this group will receive pegfilgrastim treatment, followed by filgrastim treatment at the 8-week mark 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 Pegfilgrastim: long-acting covalent conjugate of recombinant methionyl human filgrastim and monomethoxypolyethylene glycol (PEG); administered via syringe |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| BMI | Mean | Standard Deviation | kg |
|
| Weight | Mean | Standard Deviation | kg |
|
| OG001 | Pegfilgrastim to Filgrastim | Participants who first received pegfilgrastim treatment, followed by a washout period of 8 weeks. These participants then received filgrastim treatment at the 8-week mark. |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Total Nucleated Cell (TNC) Count | 8 weeks from enrollment, upon switch in treatment from filgrastim/pegfilgrastim |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Pegfilgrastim to Filgrastim | Participants who first received pegfilgrastim treatment, followed by a washout period of 8 weeks. These participants then received filgrastim treatment at the 8-week mark. | 0 | 5 | 0 | 5 | 0 | 5 |
Not provided
Not provided
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |