Knee OsteoarthristisPhase 4PRP-PEPCNCT07491367
Pilot Exploration of Platelet Characterization of Platelet Rich Plasma Created by Two Different Systems
A Phase 4 study testing Platelet Rich Plasma, Emcyte PurePRP Supraphysiologic Concentrating System and APEX Biologix XCELL PRP System in people with Knee Osteoarthristis and Cartilage Damage, run by University of California, San Francisco at 1 site in United States.
Trial summary
The investigators would like to study the differences in the quality of Platelet Rich Plasma (PRP) between two different machines in those with knee osteoarthritis. Knee osteoarthritis means your cartilage has been worn down, and it affects your knee joint. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthristis, Cartilage Damage, Platelet Rich Plasma
- What is being tested?
- Platelet Rich Plasma, Emcyte PurePRP Supraphysiologic Concentrating System and APEX Biologix XCELL PRP System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to Sep 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Kellgren-Lawrence (KL) Grade 1-3 knee osteoarthritis
- Symptoms of knee osteoarthritis for at least 3 months before presentation in one knee
- Will be able to attend and perform physical therapy
Who cannot join
- Received injection therapy for knee osteoarthritis in the past 6 months
- Have severe arthritis diagnosed in ≥1 major joint by radiology criteria
- History of septic arthritis
- Underwent knee surgery for osteoarthritis or osteochondral defects within 1 year before randomization (e.g., autograft or allograft surgery)
- Have had high tibial osteotomy, partial knee replacement, patellar resurfacing, total knee replacement, or have existing surgical hardware in the knee
- Received a platelet-rich plasma injection elsewhere in the body within the past 3 months
Show all 12Show fewer
- Have a platelet disorder or bleeding disorder
- Have a rheumatologic disease, autoimmune disorder, immunocompromised status, or active history of cancer
- Are taking chemotherapy, require regular prednisone, or require regular anti-inflammatory use
- Are pregnant, breastfeeding, or unwilling to practice birth control during the study
- If both knees have osteoarthritis and the other knee has KL score equal to or greater than 2.
- Have uncontrolled illness, physical disability, or other contraindication to aerobic exercise training
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California San Francisco
San Francisco, California, 94158
Joel Kopcow, 970-590-0314, joel.kopcow@ucsf.edu
Anthony Luke, MD
About this study
The investigators would like to study the differences in the quality of Platelet Rich Plasma (PRP) between two different machines in those with knee osteoarthritis. Knee osteoarthritis means your cartilage has been worn down, and it affects your knee joint. Both machines, the APEX Biologix XCELL PRP System and the Emcyte PurePRP Supraphysiologic Concentrating System, are FDA approved, commercially available, and makes PRP. The investigators will check if the platelets in the PRP have different amounts or work differently. The investigators will also assess participants symptoms after the injection and compare the two different preparation systems.
- Conditions
- Knee Osteoarthristis, Cartilage Damage, Platelet Rich Plasma, Platelet Rich Plasma Injection
- Being tested
- Platelet Rich Plasma, Emcyte PurePRP Supraphysiologic Concentrating System, APEX Biologix XCELL PRP System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich PlasmaBiological
The Platelet Rich Plasma (PRP) participants will receive in this study will be made by Emcyte PurePRP Supraphysiologic Concentrating System or the APEX Biologix XCELL PRP System.
Emcyte PurePRP Supraphysiologic Concentrating SystemDevice
Platelet Rich Plasma (PRP) will be made by the Emcyte PurePRP Supraphysiologic Concentrating System.
APEX Biologix XCELL PRP SystemDevice
Platelet Rich Plasma (PRP) will be made by APEX Biologix XCELL PRP System.
| Study group | Role | What they receive |
|---|---|---|
| APEX Biologix XCELL PRP System | Active comparator | Participants in this group will receive Platelet Rich Plasma made by the APEX Biologix XCELL PRP System. Receives: Biological: Platelet Rich Plasma; Device: APEX Biologix XCELL PRP System |
| Emcyte PurePRP Supraphysiologic Concentrating System | Active comparator | Participants in this group will receive Platelet Rich Plasma made by Emcyte PurePRP Supraphysiologic Concentrating System. Receives: Biological: Platelet Rich Plasma; Device: Emcyte PurePRP Supraphysiologic Concentrating System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cellular composition and quantity using Horiba Cell counter
Compare cellular composition and quantifying PRP products between EmCyte PurePRP versus APEX Biologix XCELL PRP manufacturing systems using a Horiba Cell counter.
Measured: Day 1
Secondary outcomes (5)
Platelet Activation
Compare platelet activation state, aggregation capacity, and transcriptome between PRP manufacturing systems.
Measured: Day 1
Patient Reported Outcomes: Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Link PRP characteristics to change from baseline in Pain, Stiffness, and Physical Function at 6 months as assessed by Western Ontario and McMaster Universities Arthritis Index (WOMAC).
Measured: Enrollment to 6 months.
Patient Reported Outcome: Short Form-12 Health Survey
Link PRP characteristics to change from baseline in health and ability to complete usual activities at 6 months as assessed by Short Form-12 Health Survey, a health quality of life survey.
Measured: Enrollment to 6 months
Activity Monitor & PRP Characteristics
Link PRP count and characteristics to change from baseline activity to 6 months as assessed by activity sensors.
Measured: Enrollment to 6 months
Patient Reported Outcomes: Visual Analog Scale
Link PRP characteristics to change from baseline in Pain at 6 months as assessed by Visual Analog Scale (VAS).
Measured: Enrollment to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 Sep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthristisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Luke, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491367
- Sponsor's protocol ID
- 25-45033
- Acronym
- PRP-PEPC
- Status last verified
- Aug 2026
- First submitted
- 25 Feb 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Elgaddal N, Weeks JD. Yoga Among Adults Age 18 and Older: United States, 2022. NCHS Data Brief. 2024 Jun;(501):10.15620/cdc/156474. doi: 10.15620/cdc/156474.
PubMed 39147377Lana JFSD, Purita J, Paulus C, Huber SC, Rodrigues BL, Rodrigues AA, Santana MH, Madureira JL Jr, Malheiros Luzo AC, Belangero WD, Annichino-Bizzacchi JM. Contributions for classification of platelet rich plasma - proposal of a new classification: MARSPILL. Regen Med. 2017 Jul;12(5):565-574. doi: 10.2217/rme-2017-0042. Epub 2017 Jul 31.
PubMed 28758836Deshpande BR, Katz JN, Solomon DH, Yelin EH, Hunter DJ, Messier SP, Suter LG, Losina E. Number of Persons With Symptomatic Knee Osteoarthritis in the US: Impact of Race and Ethnicity, Age, Sex, and Obesity. Arthritis Care Res (Hoboken). 2016 Dec;68(12):1743-1750. doi: 10.1002/acr.22897. Epub 2016 Nov 3.
PubMed 27014966Leifer VP, Katz JN, Losina E. The burden of OA-health services and economics. Osteoarthritis Cartilage. 2022 Jan;30(1):10-16. doi: 10.1016/j.joca.2021.05.007. Epub 2021 May 20.
PubMed 34023527Zhao X, Shah D, Gandhi K, Wei W, Dwibedi N, Webster L, Sambamoorthi U. Clinical, humanistic, and economic burden of osteoarthritis among noninstitutionalized adults in the United States. Osteoarthritis Cartilage. 2019 Nov;27(11):1618-1626. doi: 10.1016/j.joca.2019.07.002. Epub 2019 Jul 9.
PubMed 31299387Jawanda H, Khan ZA, Warrier AA, Acuna AJ, Allahabadi S, Kaplan DJ, Ritz E, Jackson GR, Mameri ES, Batra A, Dornan G, Westrick J, Verma NN, Chahla J. Platelet-Rich Plasma, Bone Marrow Aspirate Concentrate, and Hyaluronic Acid Injections Outperform Corticosteroids in Pain and Function Scores at a Minimum of 6 Months as Intra-Articular Injections for Knee Osteoarthritis: A Systematic Review and Network Meta-analysis. Arthroscopy. 2024 May;40(5):1623-1636.e1. doi: 10.1016/j.arthro.2024.01.037. Epub 2024 Feb 7.
PubMed 38331363Dai WL, Zhou AG, Zhang H, Zhang J. Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Meta-analysis of Randomized Controlled Trials. Arthroscopy. 2017 Mar;33(3):659-670.e1. doi: 10.1016/j.arthro.2016.09.024. Epub 2016 Dec 22.
PubMed 28012636Moussa M, Lajeunesse D, Hilal G, El Atat O, Haykal G, Serhal R, Chalhoub A, Khalil C, Alaaeddine N. Platelet rich plasma (PRP) induces chondroprotection via increasing autophagy, anti-inflammatory markers, and decreasing apoptosis in human osteoarthritic cartilage. Exp Cell Res. 2017 Mar 1;352(1):146-156. doi: 10.1016/j.yexcr.2017.02.012. Epub 2017 Feb 13.
PubMed 28202394Sundman EA, Cole BJ, Karas V, Della Valle C, Tetreault MW, Mohammed HO, Fortier LA. The anti-inflammatory and matrix restorative mechanisms of platelet-rich plasma in osteoarthritis. Am J Sports Med. 2014 Jan;42(1):35-41. doi: 10.1177/0363546513507766. Epub 2013 Nov 5.
PubMed 24192391Mishra A, Tummala P, King A, Lee B, Kraus M, Tse V, Jacobs CR. Buffered platelet-rich plasma enhances mesenchymal stem cell proliferation and chondrogenic differentiation. Tissue Eng Part C Methods. 2009 Sep;15(3):431-5. doi: 10.1089/ten.tec.2008.0534.
PubMed 19216642Pavlovic V, Ciric M, Jovanovic V, Stojanovic P. Platelet Rich Plasma: a short overview of certain bioactive components. Open Med (Wars). 2016 Aug 12;11(1):242-247. doi: 10.1515/med-2016-0048. eCollection 2016.
PubMed 28352802Beitia M, Delgado D, Mercader J, Sanchez P, Lopez de Dicastillo L, Sanchez M. Action of Platelet-Rich Plasma on In Vitro Cellular Bioactivity: More than Platelets. Int J Mol Sci. 2023 Mar 10;24(6):5367. doi: 10.3390/ijms24065367.
PubMed 36982439Mariani E, Pulsatelli L, Cattini L, Dolzani P, Assirelli E, Cenacchi A, Di Martino A, Arciola CR, Filardo G. Pure Platelet and Leukocyte-Platelet-Rich Plasma for Regenerative Medicine in Orthopedics-Time- and Preparation-Dependent Release of Growth Factors and Effects on Synovial Fibroblasts: A Comparative Analysis. Int J Mol Sci. 2023 Jan 12;24(2):1512. doi: 10.3390/ijms24021512.
PubMed 36675025Oudelaar BW, Peerbooms JC, Huis In 't Veld R, Vochteloo AJH. Concentrations of Blood Components in Commercial Platelet-Rich Plasma Separation Systems: A Review of the Literature. Am J Sports Med. 2019 Feb;47(2):479-487. doi: 10.1177/0363546517746112. Epub 2018 Jan 16.
PubMed 29337592Berrigan WA, Bailowitz Z, Park A, Reddy A, Liu R, Lansdown D. A Greater Platelet Dose May Yield Better Clinical Outcomes for Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Systematic Review. Arthroscopy. 2025 Mar;41(3):809-817.e2. doi: 10.1016/j.arthro.2024.03.018. Epub 2024 Mar 19.
PubMed 38513880
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Exploration of Platelet Characterization of Platelet Rich Plasma Created by Two Different Systems
- ClinicalTrials.gov ID
- NCT07491367
- Acronym / sponsor ID
- PRP-PEPC / 25-45033
- Conditions
- Knee Osteoarthristis, Cartilage Damage, Platelet Rich Plasma, Platelet Rich Plasma Injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators would like to study the differences in the quality of Platelet Rich Plasma (PRP) between two different machines in those with knee osteoarthritis. Knee osteoarthritis means your cartilage has been worn down, and it affects your knee joint. Both machines, the APEX Biologix XCELL PRP System and the Emcyte PurePRP Supraphysiologic Concentrating System, are FDA approved, commercially available, and makes PRP. The investigators will check if the platelets in the PRP have different amounts or work differently. The investigators will also assess participants symptoms after the injection and compare the two different preparation systems.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APEX Biologix XCELL PRP System | Active comparator | Biological: Platelet Rich Plasma, Device: APEX Biologix XCELL PRP SystemParticipants in this group will receive Platelet Rich Plasma made by the APEX Biologix XCELL PRP System. |
| Emcyte PurePRP Supraphysiologic Concentrating System | Active comparator | Biological: Platelet Rich Plasma, Device: Emcyte PurePRP Supraphysiologic Concentrating SystemParticipants in this group will receive Platelet Rich Plasma made by Emcyte PurePRP Supraphysiologic Concentrating System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Kellgren-Lawrence (KL) Grade 1-3 knee osteoarthritis
- Symptoms of knee osteoarthritis for at least 3 months before presentation in one knee
- Will be able to attend and perform physical therapy
Key exclusion criteria (12 listed)
- Received injection therapy for knee osteoarthritis in the past 6 months
- Have severe arthritis diagnosed in ≥1 major joint by radiology criteria
- History of septic arthritis
- Underwent knee surgery for osteoarthritis or osteochondral defects within 1 year before randomization (e.g., autograft or allograft surgery)
- Have had high tibial osteotomy, partial knee replacement, patellar resurfacing, total knee replacement, or have existing surgical hardware in the knee
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet Rich PlasmaThe Platelet Rich Plasma (PRP) participants will receive in this study will be made by Emcyte PurePRP Supraphysiologic Concentrating System or the APEX Biologix XCELL PRP System. | Biological | APEX Biologix XCELL PRP System, Emcyte PurePRP Supraphysiologic Concentrating System |
| Emcyte PurePRP Supraphysiologic Concentrating SystemPlatelet Rich Plasma (PRP) will be made by the Emcyte PurePRP Supraphysiologic Concentrating System. | Device | Emcyte PurePRP Supraphysiologic Concentrating System |
| APEX Biologix XCELL PRP SystemPlatelet Rich Plasma (PRP) will be made by APEX Biologix XCELL PRP System. | Device | APEX Biologix XCELL PRP System |
Primary outcome
Cellular composition and quantity using Horiba Cell counter
Time frame: Day 1
Compare cellular composition and quantifying PRP products between EmCyte PurePRP versus APEX Biologix XCELL PRP manufacturing systems using a Horiba Cell counter.
5 secondary outcomes
Platelet Activation
Time frame: Day 1
Patient Reported Outcomes: Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: Enrollment to 6 months.
Patient Reported Outcome: Short Form-12 Health Survey
Time frame: Enrollment to 6 months
Activity Monitor & PRP Characteristics
Time frame: Enrollment to 6 months
Patient Reported Outcomes: Visual Analog Scale
Time frame: Enrollment to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Background: PubMed 39147377Elgaddal N, Weeks JD. Yoga Among Adults Age 18 and Older: United States, 2022. NCHS Data Brief. 2024 Jun;(501):10.15620/cdc/156474. doi: 10.15620/cdc/156474.
- Background: PubMed 28758836Lana JFSD, Purita J, Paulus C, Huber SC, Rodrigues BL, Rodrigues AA, Santana MH, Madureira JL Jr, Malheiros Luzo AC, Belangero WD, Annichino-Bizzacchi JM. Contributions for classification of platelet rich plasma - proposal of a new classification: MARSPILL. Regen Med. 2017 Jul;12(5):565-574. doi: 10.2217/rme-2017-0042. Epub 2017 Jul 31.
- Background: PubMed 27014966Deshpande BR, Katz JN, Solomon DH, Yelin EH, Hunter DJ, Messier SP, Suter LG, Losina E. Number of Persons With Symptomatic Knee Osteoarthritis in the US: Impact of Race and Ethnicity, Age, Sex, and Obesity. Arthritis Care Res (Hoboken). 2016 Dec;68(12):1743-1750. doi: 10.1002/acr.22897. Epub 2016 Nov 3.
- Background: PubMed 34023527Leifer VP, Katz JN, Losina E. The burden of OA-health services and economics. Osteoarthritis Cartilage. 2022 Jan;30(1):10-16. doi: 10.1016/j.joca.2021.05.007. Epub 2021 May 20.
- Background: PubMed 31299387Zhao X, Shah D, Gandhi K, Wei W, Dwibedi N, Webster L, Sambamoorthi U. Clinical, humanistic, and economic burden of osteoarthritis among noninstitutionalized adults in the United States. Osteoarthritis Cartilage. 2019 Nov;27(11):1618-1626. doi: 10.1016/j.joca.2019.07.002. Epub 2019 Jul 9.
- Background: PubMed 38331363Jawanda H, Khan ZA, Warrier AA, Acuna AJ, Allahabadi S, Kaplan DJ, Ritz E, Jackson GR, Mameri ES, Batra A, Dornan G, Westrick J, Verma NN, Chahla J. Platelet-Rich Plasma, Bone Marrow Aspirate Concentrate, and Hyaluronic Acid Injections Outperform Corticosteroids in Pain and Function Scores at a Minimum of 6 Months as Intra-Articular Injections for Knee Osteoarthritis: A Systematic Review and Network Meta-analysis. Arthroscopy. 2024 May;40(5):1623-1636.e1. doi: 10.1016/j.arthro.2024.01.037. Epub 2024 Feb 7.
- Background: PubMed 28012636Dai WL, Zhou AG, Zhang H, Zhang J. Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Meta-analysis of Randomized Controlled Trials. Arthroscopy. 2017 Mar;33(3):659-670.e1. doi: 10.1016/j.arthro.2016.09.024. Epub 2016 Dec 22.
- Background: PubMed 28202394Moussa M, Lajeunesse D, Hilal G, El Atat O, Haykal G, Serhal R, Chalhoub A, Khalil C, Alaaeddine N. Platelet rich plasma (PRP) induces chondroprotection via increasing autophagy, anti-inflammatory markers, and decreasing apoptosis in human osteoarthritic cartilage. Exp Cell Res. 2017 Mar 1;352(1):146-156. doi: 10.1016/j.yexcr.2017.02.012. Epub 2017 Feb 13.
- Background: PubMed 24192391Sundman EA, Cole BJ, Karas V, Della Valle C, Tetreault MW, Mohammed HO, Fortier LA. The anti-inflammatory and matrix restorative mechanisms of platelet-rich plasma in osteoarthritis. Am J Sports Med. 2014 Jan;42(1):35-41. doi: 10.1177/0363546513507766. Epub 2013 Nov 5.
- Background: PubMed 19216642Mishra A, Tummala P, King A, Lee B, Kraus M, Tse V, Jacobs CR. Buffered platelet-rich plasma enhances mesenchymal stem cell proliferation and chondrogenic differentiation. Tissue Eng Part C Methods. 2009 Sep;15(3):431-5. doi: 10.1089/ten.tec.2008.0534.
- Background: PubMed 28352802Pavlovic V, Ciric M, Jovanovic V, Stojanovic P. Platelet Rich Plasma: a short overview of certain bioactive components. Open Med (Wars). 2016 Aug 12;11(1):242-247. doi: 10.1515/med-2016-0048. eCollection 2016.
- Background: PubMed 36982439Beitia M, Delgado D, Mercader J, Sanchez P, Lopez de Dicastillo L, Sanchez M. Action of Platelet-Rich Plasma on In Vitro Cellular Bioactivity: More than Platelets. Int J Mol Sci. 2023 Mar 10;24(6):5367. doi: 10.3390/ijms24065367.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anthony Luke, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Platelet Rich Plasma, Emcyte PurePRP Supraphysiologic Concentrating System and APEX Biologix XCELL PRP System in people with Knee Osteoarthristis and Cartilage Damage, run by University of California, San Francisco 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 3 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 18 Aug 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joel Kopcow (970-590-0314, joel.kopcow@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cellular composition and quantity using Horiba Cell counter (time frame: Day 1). 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 NCT07491367, which also lists 27 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 18 Aug 2026.