Chronic Radiation UlcerPhase 1/2NCT06793748
Study to Evaluate the Safety, Tolerability, and Efficacy of PEP-TISSEEL in Subjects With Chronic Radiation Ulcer
A Phase 1/2 study testing PEP-TISSEEL and TISSEEL Fibrin Sealant KIT in people with Chronic Radiation Ulcer, run by Rion Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Radiation Ulcer
- What is being tested?
- PEP-TISSEEL and TISSEEL Fibrin Sealant KIT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2025to Feb 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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:
- Female participants of non-childbearing potential defined as : i. Postmenopausal for at least 1 year (participant verbal confirmation acceptable), or surgically sterilized (i.e., hysterectomy or bilateral oophorectomy more than 3 months prior to screening); or ii. Bilateral tubal ligation more than 6 months prior to screening; or iii. Must have a negative β-hCG blood pregnancy test at screening and not be breastfeeding prior to being administered with the IP b. Male participants of non-childbearing potential are defined as those vasectomized participants whose vasectomy was performed 6 months prior to screening or those diagnosed as sterile by a physician c. Females and males of childbearing potential who practice an acceptable method of contraception defined as the use of any form of hormonal contraceptive, a barrier method with spermicide, condoms, intrauterine device, or abstinence from sexual intercourse starting at least 60 days prior to screening and continuing at least 30 days following the last treatment. Female will undergo pregnancy tests and must have a negative β-hCG blood pregnancy test at screening visit and negative urine pregnancy test at baseline visit and must not be breastfeeding prior to being administered with the IP. Other Inclusion 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
- Participants must be willing to undergo all clinical investigation-related procedures and attend all required visits including all follow-up visits Exclusion Criteria
- 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
- Positive test for HBV, HCV, HIV Other Exclusion Criteria
- 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
- Pregnancy, including a positive pregnancy test at screening, or lactation
- Likely inability to comply with the protocol or cooperate fully with the Investigator and study site personnel
- Known or suspected active abuse of alcohol, or non-prescription drugs
- Participants who are incarcerated for any reason
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20814
Patrick Walker, MD, 301-295-8028, Patrick.Walker@usuhs.edu
About this study
Official title: 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
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
- Being tested
- PEP-TISSEEL, TISSEEL Fibrin Sealant KIT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEP-TISSEELCombination product
Purified Exosome Product (PEP™) and Fibrin Sealant (TISSEEL® VH SD Kit) (Biologic) (PEP-TISSEEL)
TISSEEL Fibrin Sealant KITDrug
Fibrin Sealant (TISSEEL® VH SD Kit)
PEP-TISSEELCombination product
Purified Exosome Product (PEP™) and Fibrin Sealant (TISSEEL® VH SD Kit) (Biologic) (PEP-TISSEEL)
TISSEEL Fibrin Sealant KITDrug
Fibrin Sealant (TISSEEL® VH SD Kit)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: 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). Receives: Drug: TISSEEL Fibrin Sealant KIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1(Phse1): Incidence of Treatment-Emergent Adverse Events (TEAEs) and Incidence of withdrawals from the study due to TEAEs
Measured: 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
Measured: 20 weeks
Secondary outcomes (4)
Part 1(Phase1): 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
Measured: 20 weeks
Part 2(Phase2): Wound area change (%) during the 20 weeks of the Treatment Phase
Measured: 20 weeks
Part 2(Phase2): Time to complete wound closure during the 20 weeks of the Treatment Phase
Measured: 20 weeks
Part 2(Phase2):Incidence of Treatment-Emergent Adverse Events (TEAEs)
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study startJun 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Radiation UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rion Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Henry M. Jackson Foundation for the Advancement of Military Medicine, Walter Reed National Military Medical Center
- Responsible party
- Sponsor
- Investigators
- Patrick Walker, MD, Principal investigator, Walter Reed National Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793748
- Sponsor's protocol ID
- PRO-00180
- Status last verified
- Apr 2025
- First submitted
- 16 Jan 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06793748
- Acronym / sponsor ID
- PRO-00180
- Conditions
- Chronic Radiation Ulcer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Rion Inc.Industry (pharma, biotech, devices)
- Collaborators
- Henry M. Jackson Foundation for the Advancement of Military Medicine, Walter Reed National Military Medical Center
- Study start
- Jun 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1-PEP-TISSEEL | Experimental | Combination Product: PEP-TISSEELPart 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). |
| Part 1(Phase1) -TISSEEL-Only | Placebo comparator | Drug: TISSEEL Fibrin Sealant KITPart 1:Participants in the TISSEEL-Only group will receive 1 topical application per week of 10 mL TISSEEL for 20 weeks (5 months). |
| Part 2 (Phase2)-PEP-TISSEEL | Experimental | Combination Product: PEP-TISSEELPart 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). |
| Part 2(Phase2)-TISSEEL-Only | Placebo comparator | Drug: TISSEEL Fibrin Sealant KITPart 2:Participants in the TISSEEL-Only group will receive 1 topical application per week of 10 mL TISSEEL for 20 weeks (5 months). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (35 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEP-TISSEELPurified Exosome Product (PEP™) and Fibrin Sealant (TISSEEL® VH SD Kit) (Biologic) (PEP-TISSEEL) | Combination product | Part 1-PEP-TISSEEL |
| TISSEEL Fibrin Sealant KITFibrin Sealant (TISSEEL® VH SD Kit) | Drug | Part 1(Phase1) -TISSEEL-Only |
| PEP-TISSEELPurified Exosome Product (PEP™) and Fibrin Sealant (TISSEEL® VH SD Kit) (Biologic) (PEP-TISSEEL) | Combination product | Part 2 (Phase2)-PEP-TISSEEL |
| TISSEEL Fibrin Sealant KITFibrin Sealant (TISSEEL® VH SD Kit) | Drug | Part 2(Phase2)-TISSEEL-Only |
Primary outcome
Part 1(Phse1): Incidence of Treatment-Emergent Adverse Events (TEAEs) and Incidence of withdrawals from the study due to TEAEs
Time frame: 20 week
Part 2 (Phase2): The proportion of participants with complete wound closure during the 20 weeks of the Treatment Phase
Time frame: 20 weeks
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
4 secondary outcomes
Part 1(Phase1): The proportion of participants with complete wound closure during the 20 weeks of the Treatment Phase
Time frame: 20 weeks
Part 2(Phase2): Wound area change (%) during the 20 weeks of the Treatment Phase
Time frame: 20 weeks
Part 2(Phase2): Time to complete wound closure during the 20 weeks of the Treatment Phase
Time frame: 20 weeks
Part 2(Phase2):Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: 20 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick Walker, MD principal investigator
Walter Reed National Military Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PEP-TISSEEL and TISSEEL Fibrin Sealant KIT in people with Chronic Radiation Ulcer, run by Rion Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 35 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shariq Khan, M.S. (847-702-4063, khan@riontx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.