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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Rion Inc.
Study ID
NCT06463132
Phase
PHASE1
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • PEP/Euflexxa — COMBINATION_PRODUCT
    Euflexxa (PMA: P010029)
  • PEP — DRUG
    PEP (Purified Exosome Product)

Study Details

Evaluate the safety and exploratory efficacy of single intra-articular injections of PEP reconstituted with 0.9% Normal Saline at a low dose (one vial PEP) and high dose (two vials PEP), with and without EUFLEXXA, for the treatment of Knee Osteoarthritis

Key Dates

Start date
Nov 1, 2024
Status verified
Jun 2024
Primary completion
Nov 1, 2025
Completion
Nov 1, 2025

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1A PEP Low Dose
    1A PEP Low Dose in Saline
  • Experimental: 1B PEP High Dose
    1B PEP High Dose in Saline
  • Experimental: 2a PEP-EUFLEXXA Low Dose
    2A PEP-EUFLEXXA Low Dose
  • Experimental: 2b PEP-EUFLEXXA High Dose
    2B PEP-EUFLEXXA High Dose

Primary Outcome Measure

Primary Safety Follow up 90 Days post injection occurrence of DLTs [ Time Frame: First 90 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905-

Find similar trials in Rochester, MN

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
Mayo Clinic in Rochester· Rochester, MN

Related Studies