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Phase 1b Clinical Trial to Evaluate PEP and EUFLEXXA for Knee Osteoarthritis (KOA)
Sponsor: Rion Inc.
Summary
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
Official title: Phase 1b Open-Label, Multi-Center, Randomized Trial to Evaluate the Safety of PEP and EUFLEXXA for the Treatment of Subjects With Knee Osteoarthritis (KOA)
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2024-11-01
Completion Date
2025-11-01
Last Updated
2024-06-17
Healthy Volunteers
Yes
Conditions
Interventions
PEP/Euflexxa
Euflexxa (PMA: P010029)
PEP
PEP (Purified Exosome Product)
Locations (1)
Mayo Clinic in Rochester
Rochester, Minnesota, United States