Trial Outcomes & Findings for Comparison of Quality and Quantity of M-PRP Cellular Content Filgrastim vs. Pegfilgrastim (NCT NCT05573386)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

15 participants

Primary outcome timeframe

at time of enrollment

Results posted on

2025-08-28

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	8	7
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Withdrawal by Subject	3	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Filgrastim to Pegfilgrastim n=5 Participants 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	Pegfilgrastim to Filgrastim n=5 Participants 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	Total n=10 Participants Total of all reporting groups
Age, Continuous	28.3 years STANDARD_DEVIATION 6.48 • n=5 Participants	28.3 years STANDARD_DEVIATION 6.48 • n=5 Participants	28.3 years STANDARD_DEVIATION 6.48 • n=10 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=10 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=5 Participants	10 Participants n=10 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Height	181.42 cm STANDARD_DEVIATION 8.24 • n=5 Participants	181.42 cm STANDARD_DEVIATION 8.24 • n=5 Participants	181.42 cm STANDARD_DEVIATION 8.24 • n=10 Participants
BMI	25.29 kg STANDARD_DEVIATION 3.8 • n=5 Participants	25.29 kg STANDARD_DEVIATION 3.8 • n=5 Participants	25.29 kg STANDARD_DEVIATION 3.8 • n=10 Participants
Weight	83.1 kg STANDARD_DEVIATION 12.24 • n=5 Participants	83.1 kg STANDARD_DEVIATION 12.24 • n=5 Participants	83.1 kg STANDARD_DEVIATION 12.24 • n=10 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Filgrastim to Pegfilgrastim n=5 Participants 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.	Pegfilgrastim to Filgrastim n=5 Participants 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.
Arthrex Angel System for PRP Concentration	61.73 CD45+ cells/uL Standard Deviation 9.35	60.86 CD45+ cells/uL Standard Deviation 12.34

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Filgrastim to Pegfilgrastim n=5 Participants 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.	Pegfilgrastim to Filgrastim n=5 Participants 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.
Arthrex Angel System for PRP Concentration	6,939.20 Total Nucleated Cell (TNC) Count Standard Deviation 6,252.24	8,923.20 Total Nucleated Cell (TNC) Count Standard Deviation 3,258.09

Adverse Events

Filgrastim to Pegfilgrastim

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pegfilgrastim to Filgrastim

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Research

Andrews Research & Education Foundation

Phone: 8509168570

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place