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HealthyM-PRPNCT05573386

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

An observational study of Healthy, run by Andrews Research & Education Foundation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 39 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Filgrastim and Pegfilgrastim
Type of treatment
Injection or infusion
How many people
15 participants
Where
1 siteUnited States
Study dates
9 Aug 2021to 5 Oct 2023
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 39 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Study population: Healthy, male, college to adult aged males weighing between 50 and 100kg are the focus demographic of this study

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Andrews Research and Education Foundation

    Gulf Breeze, Florida, 32561

Other trials in United States

About this study

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

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?
Read more

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.

Read the 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.

Conditions
Healthy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FilgrastimDrug

    Also called Granix (tbo-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

  • PegfilgrastimDrug

    Also called Fulphila (pegfilgrastim-imdb)

    long-acting covalent conjugate of recombinant methionyl human filgrastim and monomethoxypolyethylene glycol (PEG); administered via syringe

Study groups in NCT05573386
Study groupRoleWhat they receive
Filgrastim to PegfilgrastimParticipants in this group will receive filgrastim treatment, followed by pegfilgrastim treatment at the 8-week mark.
Receives: Drug: Filgrastim; Drug: Pegfilgrastim
Pegfilgrastim to filgrastimParticipants in this group will receive pegfilgrastim treatment, followed by filgrastim treatment at the 8-week mark
Receives: Drug: Filgrastim; Drug: Pegfilgrastim

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Arthrex Angel System for PRP Concentration

    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.

    Measured: at time of enrollment

  2. Arthrex Angel System for PRP Concentration

    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.

    Measured: 8 weeks from enrollment, upon switch in treatment from filgrastim/pegfilgrastim

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2022
  2. Study start9 Aug 2021
  3. Primary completion5 Aug 2023
  4. Study completion5 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05573386
Sponsor's protocol ID
MPRP
Acronym
M-PRP
Status last verified
Aug 2025
First submitted
3 Oct 2022
Last updated
28 Aug 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mock C, Cherian MN. The global burden of musculoskeletal injuries: challenges and solutions. Clin Orthop Relat Res. 2008 Oct;466(10):2306-16. doi: 10.1007/s11999-008-0416-z. Epub 2008 Aug 5.

    PubMed 18679760
  • Akpancar S, Tatar O, Turgut H, Akyildiz F, Ekinci S. The Current Perspectives of Stem Cell Therapy in Orthopedic Surgery. Arch Trauma Res. 2016 Aug 16;5(4):e37976. doi: 10.5812/atr.37976. eCollection 2016 Dec.

    PubMed 28144608
  • Hauser RA, Orlofsky A. Regenerative injection therapy with whole bone marrow aspirate for degenerative joint disease: a case series. Clin Med Insights Arthritis Musculoskelet Disord. 2013 Sep 4;6:65-72. doi: 10.4137/CMAMD.S10951. eCollection 2013.

    PubMed 24046512
  • Hernigou P, Flouzat Lachaniette CH, Delambre J, Zilber S, Duffiet P, Chevallier N, Rouard H. Biologic augmentation of rotator cuff repair with mesenchymal stem cells during arthroscopy improves healing and prevents further tears: a case-controlled study. Int Orthop. 2014 Sep;38(9):1811-8. doi: 10.1007/s00264-014-2391-1. Epub 2014 Jun 7.

    PubMed 24913770
  • Hernigou P, Poignard A, Beaujean F, Rouard H. Percutaneous autologous bone-marrow grafting for nonunions. Influence of the number and concentration of progenitor cells. J Bone Joint Surg Am. 2005 Jul;87(7):1430-7. doi: 10.2106/JBJS.D.02215.

    PubMed 15995108
  • Hernigou P, Poignard A, Zilber S, Rouard H. Cell therapy of hip osteonecrosis with autologous bone marrow grafting. Indian J Orthop. 2009 Jan;43(1):40-5. doi: 10.4103/0019-5413.45322.

    PubMed 19753178
  • Saw KY, Anz A, Siew-Yoke Jee C, Merican S, Ching-Soong Ng R, Roohi SA, Ragavanaidu K. Articular cartilage regeneration with autologous peripheral blood stem cells versus hyaluronic acid: a randomized controlled trial. Arthroscopy. 2013 Apr;29(4):684-94. doi: 10.1016/j.arthro.2012.12.008. Epub 2013 Feb 4.

    PubMed 23380230
  • Hyer CF, Berlet GC, Bussewitz BW, Hankins T, Ziegler HL, Philbin TM. Quantitative assessment of the yield of osteoblastic connective tissue progenitors in bone marrow aspirate from the iliac crest, tibia, and calcaneus. J Bone Joint Surg Am. 2013 Jul 17;95(14):1312-6. doi: 10.2106/JBJS.L.01529.

    PubMed 23864180
  • Vangsness CT Jr, Sternberg H, Harris L. Umbilical Cord Tissue Offers the Greatest Number of Harvestable Mesenchymal Stem Cells for Research and Clinical Application: A Literature Review of Different Harvest Sites. Arthroscopy. 2015 Sep;31(9):1836-43. doi: 10.1016/j.arthro.2015.03.014.

    PubMed 26354202
  • Bredeson C, Leger C, Couban S, Simpson D, Huebsch L, Walker I, Shore T, Howson-Jan K, Panzarella T, Messner H, Barnett M, Lipton J. An evaluation of the donor experience in the canadian multicenter randomized trial of bone marrow versus peripheral blood allografting. Biol Blood Marrow Transplant. 2004 Jun;10(6):405-14. doi: 10.1016/j.bbmt.2004.02.003.

    PubMed 15148494
  • Anz AW, Branch EA, Rodriguez J, Chillemi F, Bruce JR, Murphy MB, Suzuki RK, Andrews JR. Viable Stem Cells Are in the Injury Effusion Fluid and Arthroscopic Byproducts From Knee Cruciate Ligament Surgery: An In Vivo Analysis. Arthroscopy. 2017 Apr;33(4):790-797. doi: 10.1016/j.arthro.2016.09.036. Epub 2016 Dec 30.

    PubMed 28043750
  • Wankhade UD, Shen M, Kolhe R, Fulzele S. Advances in Adipose-Derived Stem Cells Isolation, Characterization, and Application in Regenerative Tissue Engineering. Stem Cells Int. 2016;2016:3206807. doi: 10.1155/2016/3206807. Epub 2016 Feb 11.

    PubMed 26981130
  • Fang W, Sun Z, Chen X, Han B, Vangsness CT Jr. Synovial Fluid Mesenchymal Stem Cells for Knee Arthritis and Cartilage Defects: A Review of the Literature. J Knee Surg. 2021 Nov;34(13):1476-1485. doi: 10.1055/s-0040-1710366. Epub 2020 May 13.

    PubMed 32403148
  • Branch EA, Matuska AM, Plummer HA, Harrison RM, Anz AW. Platelet-Rich Plasma Devices Can Be Used to Isolate Stem Cells From Synovial Fluid at the Point of Care. Arthroscopy. 2021 Mar;37(3):893-900. doi: 10.1016/j.arthro.2020.09.035. Epub 2020 Oct 1.

    PubMed 33010328
  • Morikawa D, Johnson JD, Kia C, McCarthy MBR, Macken C, Bellas N, Baldino JB, Cote MP, Mazzocca AD. Examining the Potency of Subacromial Bursal Cells as a Potential Augmentation for Rotator Cuff Healing: An In Vitro Study. Arthroscopy. 2019 Nov;35(11):2978-2988. doi: 10.1016/j.arthro.2019.05.024. Epub 2019 Oct 16.

    PubMed 31629585

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by Andrews Research & Education Foundation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arthrex Angel System for PRP Concentration (time frame: at time of enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05573386, which also lists 50 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.

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