PEP on a Skin Graft Donor Site Wound

NCT04664738 | Unknown Phase 1 DMC FDA Drug

• 2 other identifiers: PRO-0006818-004995
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine the safety of a biological therapeutic PEP in participants who have skin graft donor site wounds.

Conditions

Skin Graft

Keywords

skin graft; exosome; PEP; wound; healing

Outcome Measures

Primary Outcomes (2)

• Acute dose limiting toxicities (DLTs) of PEP / PEP-Tisseel

  The primary endpoint is to determine the acute (within first 14 days) safety and tolerability of PEP or PEP-TISSEEL, as assessed by the occurrence of DLTs on a 20-40 cm2 (but can be up to 90 cm2 if found to be clinically indicated during the graft procedure) skin graft donor site wound at escalating concentrations of PEP delivered at one time point through the 14-day DLT period.

  Up to 2 weeks (within the first 14 days) for each dosing cohort

• Maximum Tolerated Dose (MTD) of PEP / PEP-Tisseel

  The endpoint is to determine the acute (within first 14 days) safety and tolerability of PEP or PEP-TISSEEL, as assessed by the occurrence of MTDs on a 20-40 cm2 (but can be up to 90 cm2 if found to be clinically indicated during the graft procedure) skin graft donor site wound at escalating concentrations of PEP delivered at one time point through the 14-day MTD period.

  Up to 2 weeks (within the first 14 days) for each dosing cohort

Secondary Outcomes (1)

• Long Term safety of PEP / PEP-Tisseel

  6 months

Other Outcomes (1)

• Exploratory Endpoint

  6 months

Study Arms (3)

10 % PEP only

EXPERIMENTAL

Cohort 1: Subjects will receive 10% PEP to the skin graft donor wound.

Biological: 10% PEP

20% PEP only

EXPERIMENTAL

Cohort 2: Subjects will receive 20% PEP to the skin graft donor wound

Biological: 20% PEP

20% PEP and TISSEEL

EXPERIMENTAL

Cohort 3: Subjects will receive 20% PEP and TISSEEL to the skin graft donor wound.

Drug: TISSEEL; Biological: 20% PEP

Interventions

10% PEP BIOLOGICAL

PEP is comprised of platelet derived extracellular vesicles enriched in anti-inflammatory and angiogenic growth factors.

10 % PEP only

TISSEEL DRUG

Fibrin sealant made from pooled human plasma

Also known as: fibrin sealant

20% PEP and TISSEEL

20% PEP BIOLOGICAL

PEP is comprised of platelet derived extracellular vesicles enriched in anti-inflammatory and angiogenic growth factors.

20% PEP and TISSEEL; 20% PEP only

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females 18-75 years of age.
• Requiring at least two 20-40 cm2 split-thickness skin grafts by a licensed surgeon or dermatologist
• Skin graft that meets all the following criteria:
• Each graft site has a size of 20-40 cm2 (but can be up to 90 cm2 if found to be clinically indicated during the graft procedure)
• Located anywhere on the body (with exception of oral mucosal membranes)
• Split-thickness skin graft wound depth of between 8/1000-14/1000 inch
• Study donor sites are ≥ 1 cm apart
• Ability to safely undergo skin graft harvest procedure
• Capacity to provide informed consent
• Ability to comply with protocol
• Subject is judged, by the clinical investigator, to be healthy as evidenced by lack of clinically significant abnormal findings on medical history, physical examination, vital signs, and clinical laboratory tests
• Subject is able and willing to return to study site for all follow-up visits

You may not qualify if:

• Actively undergoing chemotherapy treatment (localized radiation treatment is allowed if it is not on the skin graft donor site and no active cancer is present)
• Known history of MRSA (methicillin-resistant Staphylococcus aureus)
• Known hypersensitivity to aprotinin (Trasylol®)
• Subjects who are positive for hepatitis B surface antigen (HbsAg), hepatitis C antibody or human immunodeficiency virus (HIV)
• Any known allergy or sensitivity to adhesive dressings (e.g., Tegaderm)
• Clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurological, psychiatric, immunological, gastrointestinal, hematological, or metabolic disease that is, in the opinion of the investigator, not stabilized or may otherwise impact the results of the study
• Participation in another interventional clinical study or trial in the past 30 days or concurrent participation in another interventional clinical study or trial
• Subjects with poorly controlled diabetes mellitus (Hemoglobin A1c \[HbA1c\] ≥ 8%)
• Subjects with known peripheral neuropathy, or known concomitant vascular problems (such as peripheral artery disease, arterial insufficiency, or venous hypertension) or calciphylaxis
• Subjects with burns covering ≥ 30% of Total Body Surface Area
• Currently on or planned to receive hyperbaric wound therapy
• Pregnant or lactating female subjects
• Sexually active woman of childbearing potential who is unwilling to use approved contraception method for 3 months after receiving dose of investigational drug
• Prisoners

Sponsors & Collaborators

• Rion Inc.: lead
• ProPharma Group: collaborator

Study Sites (2)

International Research Partners

Doral, Florida, 33122, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Rion company website

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Fibrin Tissue Adhesive

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Michael Sabbah, MD

  Rion Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 11, 2020
• Study Start: March 16, 2021
• Primary Completion: August 9, 2023
• Study Completion: February 2, 2024
• Last Updated: September 8, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)