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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Rion Inc.
Study ID
NCT06793748
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Chronic Radiation Ulcer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PEP-TISSEEL — COMBINATION_PRODUCT
    Purified Exosome Product (PEP™) and Fibrin Sealant (TISSEEL® VH SD Kit) (Biologic) (PEP-TISSEEL)
  • TISSEEL Fibrin Sealant KIT — DRUG
    Fibrin Sealant (TISSEEL® VH SD Kit)
  • PEP-TISSEEL — COMBINATION_PRODUCT
    Purified Exosome Product (PEP™) and Fibrin Sealant (TISSEEL® VH SD Kit) (Biologic) (PEP-TISSEEL)
  • TISSEEL Fibrin Sealant KIT — DRUG
    Fibrin Sealant (TISSEEL® VH SD Kit)

Study Details

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.

Key Dates

Start date
Jun 30, 2025
Status verified
Apr 2025
Primary completion
Nov 30, 2025
Completion
Feb 28, 2026

Study Design

Enrollment
184 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1-PEP-TISSEEL
    Part 1(Phase1): Participants in the PEP-TISSEEL group will receive 1 topical application per week of 2 vials of PEP + 10 mL TISSEEL for 20 weeks (5 months).
  • Placebo Comparator: Part 1(Phase1) -TISSEEL-Only
    Part 1:Participants in the TISSEEL-Only group will receive 1 topical application per week of 10 mL TISSEEL for 20 weeks (5 months).
  • Experimental: Part 2 (Phase2)-PEP-TISSEEL
    Part 2: Participants in the PEP-TISSEEL group will receive 1 topical application per week of 2 vials of PEP + 10 mL TISSEEL for 20 weeks (5 months).
  • Placebo Comparator: Part 2(Phase2)-TISSEEL-Only
    Part 2:Participants in the TISSEEL-Only group will receive 1 topical application per week of 10 mL TISSEEL for 20 weeks (5 months).

Primary Outcome Measure

Part 1(Phse1): Incidence of Treatment-Emergent Adverse Events (TEAEs) and Incidence of withdrawals from the study due to TEAEs [ Time Frame: 20 week ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Walter Reed National Military Medical CenterBethesdaMaryland20814
Patrick Walker, MD
[email protected]
301-295-8028

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By research site
Walter Reed National Military Medical Center· Bethesda, MD