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NOT YET RECRUITING
NCT06463132
PHASE1

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

Sponsor: Rion Inc.

View on ClinicalTrials.gov

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

Interventions

COMBINATION_PRODUCT

PEP/Euflexxa

Euflexxa (PMA: P010029)

DRUG

PEP

PEP (Purified Exosome Product)

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States