N/A N=15

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

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT05573386 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2025

Primary outcome: Primary: Arthrex Angel System for PRP Concentration — 61.73; 60.86 CD45+ cells/uL

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Filgrastim (Drug); Pegfilgrastim (Drug)
Age: Adult · 19+ yrs
Sex: Male
Sponsor: Andrews Research & Education Foundation
Primary completion: Aug 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Arthrex Angel System for PRP Concentration	6,939.20; 8,923.20	—
PRIMARY Arthrex Angel System for PRP Concentration	6,939.20; 8,923.20	—

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.

Eligibility Criteria

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05573386). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.