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Phase 1b PEP and EUFLEXXA for Knee Osteoarthritis

This study is testing the safety of two treatments, PEP (Purified Exosome Product) and EUFLEXXA, for knee osteoarthritis (KOA). Researchers want to see if these treatments, given alone or together, can help reduce knee pain. You might be able to join if you are 18-90 years old and have knee osteoarthritis that has caused daily pain for at least six months. The study will look for any serious side effects for up to 365 days after treatment. There are 24 planned participants in total.

Study design
This is an interventional study with 24 participants, testing different doses of PEP alone or with EUFLEXXA. The study will enroll participants in stages, starting with lower doses and moving to higher doses if safe.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You would be followed for safety for 90 days after the injection, and then for long-term safety up to 365 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06463132

Phase 1b Clinical Trial to Evaluate PEP and EUFLEXXA for Knee Osteoarthritis (KOA)

UNKNOWN
PHASE1Ages 18–90InterventionalTreatment
Rion Inc.
~24 participants
Updated 2024-06-17 on ClinicalTrials.gov
What's tested:PEP/EuflexxaPEP

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Safety Follow up 90 Days post injection occurrence of DLTs
Measured over First 90 days
+1 more outcome measured

Conditions

Knee Osteoarthritis

Explore related trials

Osteoarthritis of knee

NCT06463132

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic in Rochester

    Rochester, Minnesotano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Shariq Khan, M.S.
[email protected]
847-702-4063
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Diagnosis of unilateral or bilateral symptomatic KOA of at least 6 months duration (meets American College of Rheumatology/Arthritis \[ACR\] criteria)
Daily knee pain in the more symptomatic knee of ≥ 30 and ≤ 80 on a 100-point VAS for greater than 6 months
Kellgren Lawrence Grade 2 to 3 osteoarthritis in the more symptomatic knee based on standard knee radiographs
Failed conservative management including at least 2 of the following:
Lack of improvement with attempted weight loss in the past year if body mass index (BMI) \> 30 kg/m2;
Lack of response to a 4-week trial in the past year of oral acetaminophen or NSAIDs taken as needed;
Lack of response to a 4-week trial in the past year of topical NSAIDs or capsaicin applied as needed;
Lack of improvement after injection therapy with cortisone, PRP or hyaluronic acid;
Lack of improvement after a 4-week course of physical therapy in the past year; or
Lack of improvement after a 4-week trial of quadriceps strengthening home exercise program in the past year.
Requesting injection therapy for pain management
Contraceptive use by participants and their partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion

Signed informed consent as described in Appendix 1 (Section 10.1) which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Ability to comply with protocol.
Steroid or viscosupplement injection in the planned treatment knee(s) within the past 3 months.
PRP injection in the planned treatment knee(s) within the past 6 months.
History of documented allergy to intra-articular EUFLEXXA.
History of cancer including melanoma (with the exception of localized skin cancer) in the past 2 years.
HIV positive participants.
BMI \> 40 kg/m2.
Arthroscopic debridement in the planned treatment knee(s) in the last 6 months.
Cartilage restoration procedure in the planned treatment knee(s) in the last 5 years.
History of gout or pseudogout.
History of or evidence of active rheumatologic disease, severe peripheral neuropathy, clinically evident cardiac or respiratory disease that interferes with functional status.
Poorly controlled diabetes defined as a glycated hemoglobin (HbA1c) concentration of ≥ 8.0%.
Currently taking any cancer treatment regimen (including aromatase inhibitors).
Calcium pyrophosphate deposition disease (CPPD) evident on X-ray.
Systemic (oral, intravenous, or intramuscular) steroids in the last 3 months.
Concurrent participation in another investigational drug or device study or participation in the last 30 days prior to enrollment.
Evidence of recent alcohol or drug abuse, or history of medication misuse or addiction.
Female participants who are pregnant, breast feeding, or trying to become pregnant.
Women unwilling to use approved contraception method for 3 months after receiving dose of investigational drug.
Unwilling or unable to comply with Telehealth visits (eg, ability to access internet, on camera capabilities, etc).

What this trial measures

  • Primary Safety Follow up 90 Days post injection occurrence of DLTsFirst 90 days

    The safety of a single intra-articular injection of PEP, with or without EUFLEXXA, through the initial 90-day treatment period as assessed by the occurrence of DLTs with severity grading based on the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE).

  • Long Term Safety Follow-Up Occurrence of DLTs From Day 91 to Day 365Day 365

    The long-term safety after treatment with a single intra-articular injection of PEP, with or without EUFLEXXA as assessed from the incidence of DLTs during the Day 91 through Day 365 follow up period.