NCT06793748View on ClinicalTrials.gov

Study to Evaluate the Safety, Tolerability, and Efficacy of PEP-TISSEEL in Subjects With Chronic Radiation Ulcer

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

184

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

November 30, 2025

Study Completion Date

February 28, 2026

Conditions
Chronic Radiation Ulcer
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)

Trial Locations (1)

20814

Walter Reed National Military Medical Center, Bethesda

All Listed Sponsors
collaborator

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER

collaborator

Walter Reed National Military Medical Center

FED

lead

Rion Inc.

INDUSTRY