PEP-TISSEEL for Radiation Ulcer

Overseen By Maureen Maureen Merrifield, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Rion Inc.

Must not be taking: Investigational drugs

Disqualifiers: Infection, Vascular compromise, Diabetes, others

Compensation: Varies

Number of Visits: 40

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called PEP-TISSEEL for healing chronic radiation ulcers. Researchers aim to determine if PEP-TISSEEL, a topical treatment, promotes better healing than TISSEEL alone and are also assessing its safety. The trial targets individuals with skin ulcers from past radiation treatments who have not responded to standard wound care. Participants will receive weekly topical applications of either PEP-TISSEEL or TISSEEL over a 20-week period. Those with ulcers affecting daily life and unresponsive to usual care may be suitable for this trial. As a Phase 1, Phase 2 trial, this research seeks to understand the treatment's effects in people and measure its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you have used investigational drugs or biologics within 28 days prior to screening.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research is investigating whether PEP-TISSEEL is safe and effective for treating chronic radiation ulcers. Currently, there is no clear information on its safety. This trial is in the early stages, focusing primarily on assessing the treatment's safety and tolerability.

Both PEP-TISSEEL and TISSEEL are under evaluation. TISSEEL is already used in surgeries, indicating its general safety. The study closely monitors the new combination with PEP to ensure it does not cause unexpected side effects. Prospective participants should know that safety is the primary focus at this stage. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for radiation ulcer?

Researchers are excited about PEP-TISSEEL for radiation ulcers because it offers a promising new approach by combining a peptide-enhanced product with TISSEEL, a fibrin sealant. Unlike traditional treatments that often focus on wound dressings and topical antibiotics, PEP-TISSEEL uses a unique blend of peptides to potentially enhance healing and regeneration of damaged tissue. This combination could accelerate the healing process and improve outcomes for patients suffering from painful radiation ulcers. The potential for a faster, more effective healing method has generated significant interest in this treatment.

What evidence suggests that this trial's treatments could be effective for radiation ulcer?

Research has shown that PEP-TISSEEL, a combination of Purified Exosome Product (PEP™) and a glue-like substance called TISSEEL, might help treat radiation ulcers. In this trial, one group of participants will receive PEP-TISSEEL, while another group will receive only TISSEEL. Other studies have demonstrated that patients using pentoxifylline improved in these types of ulcers. This suggests that PEP-TISSEEL could also be beneficial, as its unique mix aids wound healing. Although researchers are still studying this treatment, early results are promising for reducing these difficult chronic wounds. ^{1 2 3 4 6}

Who Is on the Research Team?

Patrick Walker, MD

Principal Investigator

Walter Reed National Military Medical Center

Are You a Good Fit for This Trial?

Adults with chronic radiation ulcers can join this trial. It's not clear what specific conditions exclude someone from participating, as the exclusion criteria are not provided.

Inclusion Criteria

Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

I have a sore from radiation treatment.

Ability to comply with the study protocol

Exclusion Criteria

My wound shows signs of infection.

Likely inability to comply with the protocol or cooperate fully with the Investigator and study site personnel

Any participant with a life expectancy ≤ 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants receive 1 topical application per week of either TISSEEL-Only or PEP-TISSEEL for 20 weeks

20 weeks

20 visits (in-person)

Treatment Phase 2

Participants receive 1 topical application per week of either TISSEEL-Only or PEP-TISSEEL for 20 weeks

20 weeks

20 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PEP-TISSEEL

Trial Overview The study is testing PEP-TISSEEL, a combination of Purified Exosome Product and Fibrin Sealant, against just TISSEEL to treat chronic radiation ulcers in adults.

How Is the Trial Designed?

Group I: Part 2 (Phase2)-PEP-TISSEEL Experimental Treatment 1 Intervention

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).

Group II: Part 1-PEP-TISSEEL Experimental Treatment 1 Intervention

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).

Group III: Part 1(Phase1) -TISSEEL-Only Placebo Group 1 Intervention

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

Group IV: Part 2(Phase2)-TISSEEL-Only Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Rion Inc.

Lead Sponsor

Trials

4

Recruited

260+

Henry M. Jackson Foundation for the Advancement of Military Medicine

Collaborator

Trials

103

Recruited

94,300+

Walter Reed National Military Medical Center

Collaborator

Trials

149

Recruited

33,800+

Citations

1. theglobeandmail.com theglobeandmail.com/investing/markets/markets-news/Tipranks/35736246/rion-co-ltd-advances-clinical-study-on-pep-tisseel-for-chronic-radiation-ulcers/

Rion Co., Ltd. Advances Clinical Study on PEP-TISSEEL ... ' This study aims to evaluate the safety, tolerability, and efficacy of PEP-TISSEEL, a combination of Purified Exosome Product (PEP™) and Fibrin ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06319287

Study Details | NCT06319287 | Phase 2a Multi-Center ... The objective of this multi-center, prospective, randomized controlled study is to evaluate the safety and efficacy of PEP-TISSEEL+ Standard of Care (SOC)

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7197913/

Management of radiation-induced ulcers by singlestage ... The present study examined the possibility of using a single-stage reconstructive procedure to manage radiation-related wounds.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06793748

NCT06793748 | Study to Evaluate the Safety, Tolerability ... Study to Evaluate the Safety, Tolerability, and Efficacy of PEP-TISSEEL in Subjects With Chronic Radiation Ulcer. ClinicalTrials.gov ID NCT06793748. Sponsor ...

5. withpower.com withpower.com/trial/pep-tisseel-for-radiation-ulcer-b7d71

PEP-TISSEEL for Radiation Ulcer · Info for Participants The research mentions that pentoxifylline, a component used in other studies, has shown some effectiveness in treating radiation-induced ulcers, suggesting that ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12103788/

From bench to bedside: the research status and application ... ... Safety & Efficacy of Topical PEP-TISSEEL for Diabetic Foot Ulcers (DFU) ... This section collects any data citations, data availability ...