An observational study in Healthy, sponsored by Andrews Research & Education Foundation. Completed at 1 site in United States. Open to male participants aged 19 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-28.
Sponsored by Andrews Research & Education Foundation · Observational
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:
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.
Andrews Research & Education Foundation is the lead sponsor of 20 studies on the registry; 2 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Healthy, male, college to adult aged males weighing between 50 and 100kg are the focus demographic of this study
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will receive filgrastim treatment, followed by pegfilgrastim treatment at the 8-week mark.
Drug: Filgrastim · Drug: Pegfilgrastim
Participants in this group will receive pegfilgrastim treatment, followed by filgrastim treatment at the 8-week mark
Drug: Filgrastim · Drug: Pegfilgrastim
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)
long-acting covalent conjugate of recombinant methionyl human filgrastim and monomethoxypolyethylene glycol (PEG); administered via syringe
Also known as: Fulphila (pegfilgrastim-imdb)
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.
Time frame: 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.
Time frame: 8 weeks from enrollment, upon switch in treatment from filgrastim/pegfilgrastim
| Milestone | Filgrastim Then Pegfilgrastim | Pegfilgrastim Then Filgrastim |
|---|---|---|
| Started | 8 | 7 |
| Completed | 5 | 5 |
| Not completed | 3 | 2 |
| Withdrew: Withdrawal by subject | 3 | 2 |
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.
| CD45+ cells/uL | Filgrastim to Pegfilgrastim | Pegfilgrastim to Filgrastim |
|---|---|---|
| Arthrex Angel System for PRP Concentration | 61.73 ± 9.35 | 60.86 ± 12.34 |
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.
| Total Nucleated Cell (TNC) Count | Filgrastim to Pegfilgrastim | Pegfilgrastim to Filgrastim |
|---|---|---|
| Arthrex Angel System for PRP Concentration | 6,939.20 ± 6,252.24 | 8,923.20 ± 3,258.09 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Filgrastim to Pegfilgrastim | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Pegfilgrastim to Filgrastim | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Continuous(years) | Filgrastim to Pegfilgrastim | Pegfilgrastim to Filgrastim | Total |
|---|---|---|---|
| Mean | 28.3 ± 6.48 | 28.3 ± 6.48 | 28.3 ± 6.48 |
| Sex: Female, Male(Participants) | Filgrastim to Pegfilgrastim | Pegfilgrastim to Filgrastim | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 5 | 5 | 10 |
| Race and Ethnicity Not Collected(Participants) | Filgrastim to Pegfilgrastim | Pegfilgrastim to Filgrastim | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Height(cm) | Filgrastim to Pegfilgrastim | Pegfilgrastim to Filgrastim | Total |
|---|---|---|---|
| Mean | 181.42 ± 8.24 | 181.42 ± 8.24 | 181.42 ± 8.24 |
| BMI(kg) | Filgrastim to Pegfilgrastim | Pegfilgrastim to Filgrastim | Total |
|---|---|---|---|
| Mean | 25.29 ± 3.8 | 25.29 ± 3.8 | 25.29 ± 3.8 |
| Weight(kg) | Filgrastim to Pegfilgrastim | Pegfilgrastim to Filgrastim | Total |
|---|---|---|---|
| Mean | 83.1 ± 12.24 | 83.1 ± 12.24 | 83.1 ± 12.24 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Andrews Research & Education Foundation