A Phase I Open-Label Trial to Determine the Safety of PEP on a Skin Graft Donor Site Wound
Latest Information Update: 22 Nov 2023
At a glance
- Drugs Purified exosome product RION (Primary) ; Fibrin
- Indications Wounds
- Focus Adverse reactions
- Sponsors Rion
Most Recent Events
- 20 Nov 2023 According to a ROCHESTER, RION media release, the Rochester MN team is actively pursuing exosome-based therapeutics in multiple FDA-authorized clinical trial, including this active trial in wound healing set for estimated completion in Q1 2024.
- 07 Aug 2023 Status changed from recruiting to active, no longer recruiting.
- 23 Feb 2023 Number of arms changed from 4 to 3. Experimental: 10% PEP and TISSEEL arm removed from study protocol. Planned number of patients also increased. Eligibility criteria amended to 18 to 75 years.