An Adaptive Two-Part, Phase 1/2, Multi-Center, Double-Blinded, Randomized, Controlled Study of the Safety and Efficacy of Topically Applied PEP-TISSEEL in Participants With Chronic Radiation Ulcer
Rion Inc.
Summary
The goal of this clinical trial is to learn if drug Purified Exosome Product (PEP™) and Fibrin Sealant (TISSEEL® VH SD Kit) (PEP-TISSEEL) works to treat chronic radiation ulcer in adults and compare it with comparator TISSEEL. It will also learn about the safety of drug PEP-TISSEEL.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Participants in both study parts are eligible to be included if all of the following criteria apply: Age and Sex 1. Males and females aged ≥ 18 years at the time of signing the informed consent. Informed Consent 2. Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Type of Participant and Disease Characteristics 3. Status post-radiation treatment, with radiation-induced ulcer. This includes participants with moist desquamation as well as full epidermal necrosis and s…
Interventions
- Combination ProductPEP-TISSEEL
Purified Exosome Product (PEP™) and Fibrin Sealant (TISSEEL® VH SD Kit) (Biologic) (PEP-TISSEEL)
- DrugTISSEEL Fibrin Sealant KIT
Fibrin Sealant (TISSEEL® VH SD Kit)
- Combination ProductPEP-TISSEEL
Purified Exosome Product (PEP™) and Fibrin Sealant (TISSEEL® VH SD Kit) (Biologic) (PEP-TISSEEL)
- DrugTISSEEL Fibrin Sealant KIT
Fibrin Sealant (TISSEEL® VH SD Kit)
Location
- Walter Reed National Military Medical CenterBethesda, Maryland