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

Detailed criteria

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 Product
PEP-TISSEEL
Purified Exosome Product (PEP™) and Fibrin Sealant (TISSEEL® VH SD Kit) (Biologic) (PEP-TISSEEL)
Drug
TISSEEL Fibrin Sealant KIT
Fibrin Sealant (TISSEEL® VH SD Kit)
Combination Product
PEP-TISSEEL
Purified Exosome Product (PEP™) and Fibrin Sealant (TISSEEL® VH SD Kit) (Biologic) (PEP-TISSEEL)
Drug
TISSEEL Fibrin Sealant KIT
Fibrin Sealant (TISSEEL® VH SD Kit)

Location

Walter Reed National Military Medical Center
Bethesda, Maryland
Patrick.Walker@usuhs.edu 301-295-8028

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

Summary

Eligibility

Interventions

Location

Compensation

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Details

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