NCT06793748

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 184 (estimated)
• Sponsor: Rion Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Radiation Ulcer

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2025-06-01
• Primary completion: 2025-11-01
• Completion: 2026-02-01
• First posted: 2025-01-27
• Last updated: 2025-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study