Comparison of Quality and Quantity of M-PRP Cellular Content Filgrastim vs. Pegfilgrastim
Completed
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT05573386
- Run by
- Andrews Research & Education Foundation
- People needed
- 15
- Starts
- 2021-08-09
- Expected to finish
- 2023-10-05
- Last updated by the study team
- 2025-08-28
Who can join
Age: 19 and older, up to 39. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- Female
- Weight < 50kg or > 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.
Where it is running
- Andrews Research and Education Foundation — Gulf Breeze, Florida, United States
Full record on ClinicalTrials.gov
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