| Popis: |
Introduction: Hematopoietic stem cells (HSCs) appear in peripheral blood (PB) following mobilization due to external events or pharmaceutical agents like filgrastim and pegfilgrastim. Concentration of these into platelet-rich plasma (PRP) can be used in orthopedics. Objectives: This prospective, single-center, controlled laboratory study aimed to compare safety profiles of filgrastim and pegfilgrastim administration, quantifying the cellular content of PRP derived from PB post-administration. We hypothesized comparable rates and severity of adverse events (AEs) among participants, along with similar cellular content in the PRP products. Methods: Ten healthy male participants underwent a crossover design with 2 interventions separated by a washout period. PB was collected before and after each intervention, producing PRP for cellular comparison in vitro. AEs were monitored for severity and frequency throughout study. Results: Significant AEs for filgrastim included fatigue (36%), myalgia (36%), and back pain (9.1%), compared to pegfilgrastim, which included myalgia (31%), fatigue (23%), and back pain (23%). There were no significant differences between AE occurrences (P = .49) nor relationship to study drug (P > .99). Regarding total nucleated cell count (TNC), statistical significance was found in TNC count (P = .010) and TNC concentration (P = .004). All PRP products expressed high levels (>88%) of hematopoietic progenitor cell/HSC-specific CD45+, CD34+, CD45dim+, and hematopoietic progenitor cell/HSC+ markers. Conclusions: This study demonstrated that filgrastim and pegfilgrastim administration appear safe. Pegfilgrastim is equivalent to filgrastim for the mobilization of white blood cells and cells expressing hematopoietic cell-surface markers into the PB and consequently, into the derived PRP product. Clinical relevance: This study presents pegfilgrastim as a single-injection alternative to filgrastim for the mobilization of HSCs into the PB and subsequent PB-derived PRP, which is more convenient and less invasive for patients. |
