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

NCT06793748 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: PRO-00180
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Part 1(Phse1): Incidence of Treatment-Emergent Adverse Events (TEAEs) and Incidence of withdrawals from the study due to TEAEs

  20 week

• Part 2 (Phase2): The proportion of participants with complete wound closure during the 20 weeks of the Treatment Phase

  Complete wound closure of the index ulcer is defined as 100% re-epithelialization without drainage or dressing requirements confirmed at 2 consecutive study visits 2 weeks apart

  20 weeks

Secondary Outcomes (4)

• Part 1(Phase1): The proportion of participants with complete wound closure during the 20 weeks of the Treatment Phase

  20 weeks

• Part 2(Phase2): Wound area change (%) during the 20 weeks of the Treatment Phase

  20 weeks

• Part 2(Phase2): Time to complete wound closure during the 20 weeks of the Treatment Phase

  20 weeks

• Part 2(Phase2):Incidence of Treatment-Emergent Adverse Events (TEAEs)

  20 weeks

Study Arms (4)

Part 1-PEP-TISSEEL

EXPERIMENTAL

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).

Combination Product: PEP-TISSEEL

Part 1(Phase1) -TISSEEL-Only

PLACEBO COMPARATOR

Part 1:Participants in the TISSEEL-Only group will receive 1 topical application per week of 10 mL TISSEEL for 20 weeks (5 months).

Drug: TISSEEL Fibrin Sealant KIT

Part 2 (Phase2)-PEP-TISSEEL

EXPERIMENTAL

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).

Combination Product: PEP-TISSEEL

Part 2(Phase2)-TISSEEL-Only

PLACEBO COMPARATOR

Part 2:Participants in the TISSEEL-Only group will receive 1 topical application per week of 10 mL TISSEEL for 20 weeks (5 months).

Drug: TISSEEL Fibrin Sealant KIT

Interventions

PEP-TISSEEL COMBINATION_PRODUCT

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

Part 1-PEP-TISSEEL

TISSEEL Fibrin Sealant KIT DRUG

Fibrin Sealant (TISSEEL® VH SD Kit)

Part 1(Phase1) -TISSEEL-Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants in both study parts are eligible to be included if all of the following criteria apply:
• Age and Sex
• Males and females aged ≥ 18 years at the time of signing the informed consent. Informed Consent
• 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
• Status post-radiation treatment, with radiation-induced ulcer. This includes participants with moist desquamation as well as full epidermal necrosis and superficial dermal ulcerations (this wound would otherwise be allowed to heal by secondary intention).
• Index ulcer classified as Grade 1 to Grade 3 according to the NCI-CTCAE, Version 5.0
• Area of index ulcer must be between 1 and 15 cm2 at screening and at randomization/baseline.
• Have failed conservative treatments including attempts at washing and local wound care, and be seeking therapy
• The chronic radiation ulcers are limited to cutaneous (skin) ulcers and not impacting mucosal (oral, nose, etc.) tissue. Sex and Contraceptive/Barrier Requirements
• Must meet one of the following criteria:
• Participants must be deemed by Radiation Oncologist at or greater than 6 months status/post-treatment to be without evidence of local recurrence
• Ability to comply with the study protocol

You may not qualify if:

• Participants in both study parts are excluded if any of the following criteria apply:
• Medical Conditions
• Study wound exhibits clinical signs and symptoms of infection at the screening visit
• Any participant that has vascular compromise that is untreated as defined by as by defined abnormal invasive or non-invasive vascular studies
• The index ulcer is within 2 cm of any other ulcer
• The non-Cutaneous CRUs and ulcers impacting mucosal (oral, nose, etc.) tissue Liver Safety
• Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 3 x upper limit of normal (ULN) Prior/Concurrent Clinical Study Experience
• Use of investigational drugs or biologics within 28 days prior to screening
• Participation in another interventional clinical study in the past 30 days or concurrent participation in another interventional clinical study Diagnostic Assessments
• Hemoglobin A1c (HbA1c) \> 8%
• Serum creatinine l \> 2.5 mg/dL
• Absolute neutrophil count of \<500 neutrophils per mm3 over the course of enrollment
• Active tanning, including the use of tanning booths, during the course of the study
• Any participant who would be unable to safely monitor the infection status of the index ulcer at home and return for scheduled visits
• Any participant with a life expectancy ≤ 6 months

Sponsors & Collaborators

• Rion Inc.: lead
• Henry M. Jackson Foundation for the Advancement of Military Medicine: collaborator
• Walter Reed National Military Medical Center: collaborator

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20814, United States

Location

Study Officials

• Patrick Walker, MD

  Walter Reed National Military Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shariq Khan, M.S.

CONTACT

847-702-4063; khan@riontx.com

Maureen Maureen Merrifield, Ph.D.

CONTACT

281-914-6228; merrifield@rion.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Phase 1 is open label, Phase 2 is controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 27, 2025
• Study Start: June 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: February 1, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

US (1)