20 Participants NeededMy employer runs this trial

Platelet Rich Plasma for Knee Arthritis

(PRP-PEPC Trial)

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Overseen ByJoel Kopcow
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how two different machines prepare Platelet Rich Plasma (PRP) for treating knee osteoarthritis, a condition where knee cartilage wears down. Researchers aim to determine if PRP from these machines affects symptoms differently. Participants will receive PRP injections prepared by either the APEX Biologix XCELL PRP System or the Emcyte PurePRP Supraphysiologic Concentrating System. This trial may suit individuals who have experienced knee osteoarthritis symptoms for at least three months and can participate in physical therapy. As a Phase 4 trial, it involves an FDA-approved treatment, seeking to understand its benefits for more patients.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are taking chemotherapy, regular prednisone, or regular anti-inflammatory medications, you may not be eligible to participate.

What is the safety track record for Platelet Rich Plasma treatments?

Research has shown that Platelet Rich Plasma (PRP) treatments are generally well-tolerated. The FDA has approved the APEX Biologix XCELL PRP System and the Emcyte PurePRP Supraphysiologic Concentrating System for preparing PRP, indicating their safety.

Previous studies found that PRP injections can relieve pain from knee osteoarthritis, where the knee joint cartilage wears down. Many patients experience pain relief for 6 to 12 months after treatment. Side effects are usually mild and may include temporary pain or swelling at the injection site.

Overall, using PRP from these systems has proven safe, with patients generally tolerating it well.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using Platelet Rich Plasma (PRP) for knee arthritis because it offers a regenerative approach to treatment. Unlike standard options like pain relievers and physical therapy, PRP uses components derived from the patient's own blood to potentially stimulate healing in the knee joint. The APEX Biologix XCELL PRP System and Emcyte PurePRP Supraphysiologic Concentrating System both produce PRP with high concentrations of platelets, which may enhance the body's natural repair processes. This innovative method has the potential to not only alleviate pain but also improve joint function, offering a promising alternative to conventional management methods for knee arthritis.

What evidence suggests that this trial's treatments could be effective for knee arthritis?

This trial compares two methods of delivering platelet-rich plasma (PRP) for knee osteoarthritis: the APEX Biologix XCELL PRP System and the Emcyte PurePRP Supraphysiologic Concentrating System. Studies have shown that PRP injections can alleviate knee osteoarthritis. Patients using either system often experience pain relief for 6 to 12 months post-treatment. Research suggests a 60% to 70% chance that PRP will effectively reduce knee pain and enhance movement. Additionally, PRP has proven to be as effective, or even superior, to other common treatments like hyaluronic acid injections. Both systems have FDA approval, ensuring they meet safety standards for use.12456

Who Is on the Research Team?

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Anthony Luke, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults with mild to moderate knee osteoarthritis in one knee, who have had symptoms for at least 3 months and can do physical therapy. People can't join if they've recently had certain injections or surgeries, have severe arthritis elsewhere, immune problems, cancer history, are pregnant/breastfeeding, or have bleeding disorders.

Inclusion Criteria

Will be able to attend and perform physical therapy
My knee osteoarthritis is mild to moderate.
I have had knee osteoarthritis symptoms in one knee for at least 3 months.

Exclusion Criteria

I have had injection therapy for my knee osteoarthritis in the last 6 months.
Both my knees have osteoarthritis, and my other knee has moderate or worse damage.
Have uncontrolled illness, physical disability, or other contraindication to aerobic exercise training
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Platelet Rich Plasma injections using either the APEX Biologix XCELL PRP System or the Emcyte PurePRP Supraphysiologic Concentrating System

1 day
1 visit (in-person)

Follow-up

Participants are monitored for changes in symptoms and PRP characteristics over time

6 months
Multiple assessments (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Platelet Rich Plasma

Trial Overview

The study compares two FDA-approved machines (APEX Biologix XCELL PRP System and Emcyte PurePRP Supraphysiologic Concentrating System) that prepare platelet-rich plasma (PRP) used for injection into the knee. Researchers will look at differences in PRP quality and patient symptoms after treatment.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: APEX Biologix XCELL PRP SystemActive Control2 Interventions
Group II: Emcyte PurePRP Supraphysiologic Concentrating SystemActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Citations

PRP-PEPC | Comparison of Platelet Rich Plasma Quality in ...

This study aims to compare the cellular composition and quantity of Platelet Rich Plasma (PRP) products produced by the EmCyte PurePRP and APEX ...

Cutting Through the Noise: The Real Evidence Behind XCELL ...

Platelet-Rich Plasma Intra-Articular Knee Injections ... Greater Platelet Dose May Yield Better Clinical Outcomes for Platelet-Rich Plasma.

Efficacy of Platelet-Rich Plasma Injections in Knee Osteoarthritis

The study was conducted to evaluate the safety and effectiveness of platelet-rich plasma (PRP) injections for knee osteoarthritis.

Study Details | NCT07491367 | Pilot Exploration of Platelet ...

The investigators would like to study the differences in the quality of Platelet Rich Plasma (PRP) between two different machines in those with knee ...

Platelet Rich Plasma

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 ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41107915/

Efficacy and safety of platelet-rich plasma injections for the ...

This comprehensive evaluation of PRP therapy for KOA identified key parameters associated with optimal treatment outcomes, including PRP ...