drugset / Trial / NCT06793748
Study to Evaluate the Safety, Tolerability, and Efficacy of PEP-TISSEEL in Subjects With Chronic Radiation Ulcer
Phase 1/2
Not yet recruiting
184 enrolled
Rion Inc.
Henry M. Jackson Foundation for the Advancement of Military Medicine · collabWalter Reed National Military Medical Center · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2025-06
- Primary completion
- 2025-11
- Completion
- 2026-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fibrinogen Concentrate Human | Protein / enzyme biologic | 10 ml | Topical |
| Subject | Purified Exosome Product | Unknown | — | Topical |