PEP and Euflexxa for Osteoarthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety and potential benefits of a new treatment for knee osteoarthritis. Participants will receive varying doses of a treatment called PEP, with some also receiving Euflexxa, a type of hyaluronic acid injection. The trial seeks individuals who have experienced knee osteoarthritis for at least six months and have not found relief with other treatments such as pain relievers, physical therapy, or injections. If daily knee pain persists despite these methods, this trial might be suitable. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you have had steroid or viscosupplement injections in the last 3 months, or PRP injections in the last 6 months, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that PEP, a type of platelet-rich plasma, is generally safe for treating knee osteoarthritis (OA). It has improved joint function and reduced pain in other studies, with patients tolerating it well and few reports of side effects.
Research on Euflexxa, a hyaluronic acid injection, suggests it is also safe for knee OA. One study found it was well-tolerated over 26 weeks, with only some patients experiencing joint swelling, which was uncommon.
Both PEP and Euflexxa have good safety records, making them promising options for those considering this clinical trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for osteoarthritis because they explore new combinations and dosages of PEP and Euflexxa, which could offer enhanced relief. Unlike standard treatments like NSAIDs or corticosteroid injections, PEP involves a unique mechanism by potentially targeting inflammation at a molecular level, while Euflexxa is a form of hyaluronic acid that lubricates joints. The combination of PEP and Euflexxa in different doses might provide more comprehensive symptom management, potentially improving both pain and joint function more effectively than current options.
What evidence suggests that this trial's treatments could be effective for knee osteoarthritis?
Research has shown that platelet-rich plasma (PRP), a key component of PEP, can improve knee osteoarthritis more effectively than hyaluronic acid alone. Studies have found that PRP is safe and helps reduce pain while improving knee movement. In this trial, some participants will receive PEP alone, while others will receive the PEP/Euflexxa combination. Combining PRP with hyaluronic acid, as in the PEP/Euflexxa treatment, may offer even greater benefits for those with moderate knee osteoarthritis. Patients have reported less pain and better knee function in both short- and mid-term assessments. These findings suggest that PEP and PEP/Euflexxa could be effective options for managing knee osteoarthritis.16789
Are You a Good Fit for This Trial?
This trial is for individuals with knee osteoarthritis. Participants should be adults who are experiencing symptoms and have not found relief from other treatments. Details on specific inclusion or exclusion criteria are not provided, but typically these would outline the severity of osteoarthritis, age range, overall health status, and any medications or conditions that might interfere with the trial.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intra-articular injection of PEP, with or without EUFLEXXA, at low or high doses
Primary Safety Follow-up
Participants are monitored for safety through the occurrence of DLTs for 90 days post-injection
Long Term Safety Follow-up
Participants are monitored for long-term safety from Day 91 to Day 365 post-injection
What Are the Treatments Tested in This Trial?
Interventions
- PEP
- PEP/Euflexxa
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rion Inc.
Lead Sponsor
Caidya Clinical Research Organization
Collaborator