Clinical trial NCT05573386: Comparison of Quality and Quantity of M-PRP Cellular Content Filgrastim vs. Pegfilgrastim
Official title: A Single Center, Prospective Study to Compare the Quality and Quantity of the Cellular Content of M-PRP Harvested After Peripheral Mobilization of Progenitor Cells Using Filgrastim Versus Pegfilgrastim
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Lead sponsor: Andrews Research & Education Foundation
Sponsor class: OTHER
Collaborators: name: Florida
First posted: 2022-10-10
Enrollment: 10
Sex: MALE
Minimum age (years): 19
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy, male, college to adult aged males weighing between 50 and 100kg are the focus demographic of this study

Brief 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.

Detailed description: 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.

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 \< 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.

Primary outcomes:
measure: Arthrex Angel system for PRP concentration
timeFrame: at time of enrollment
measure: Arthrex Angel system for PRP concentration
timeFrame: 8 weeks from enrollment, upon switch in treatment from filgrastim/pegfilgrastim
Secondary outcomes:
Other outcomes:
Locations:
city: Gulf Breeze
country: United States
facility: Andrews Research and Education Foundation
state: Florida
Study officials:
affiliation: Orthopedic Surgeon
name: Adam Anz, MD
role: PRINCIPAL_INVESTIGATOR
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