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PEP on a Skin Graft Donor Site Wound

A Phase I Open-Label Trial to Determine the Safety of PEP on a Skin Graft Donor Site Wound

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04664738
Enrollment
8
Registered
2020-12-11
Start date
2021-03-16
Completion date
2024-02-02
Last updated
2023-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Graft

Keywords

skin graft, exosome, PEP, wound, healing

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.

Detailed description

This is an open label phase 1b study of PEP (a leukocyte depleted blood preparation derived from human U.S. sourced pooled apheresed platelets) in patients with at least two donor split-thickness skin graft wounds. One donor site will be treated with the standard post-operative dressing, while the other site will be treated with PEP or PEP+TISSEEL and covered with a standard dressing. TISSEEL is a commercially available fibrin sealant.

Interventions

BIOLOGICAL10% PEP

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

Fibrin sealant made from pooled human plasma

BIOLOGICAL20% PEP

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

Sponsors

ProPharma Group
CollaboratorINDUSTRY
Rion Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Main Criteria for Inclusion: 1. Males and females 18-75 years of age. 2. Requiring at least two 20-40 cm2 split-thickness skin grafts by a licensed surgeon or dermatologist 3. Skin graft that meets all the following criteria: 1. 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) 2. Located anywhere on the body (with exception of oral mucosal membranes) 3. Split-thickness skin graft wound depth of between 8/1000-14/1000 inch 4. Study donor sites are ≥ 1 cm apart 4. Ability to safely undergo skin graft harvest procedure 5. Capacity to provide informed consent 6. Ability to comply with protocol 7. 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 8. Subject is able and willing to return to study site for all follow-up visits Main Criteria for Exclusion: 1. 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) 2. Known history of MRSA (methicillin-resistant Staphylococcus aureus) 3. Known hypersensitivity to aprotinin (Trasylol®) 4. Subjects who are positive for hepatitis B surface antigen (HbsAg), hepatitis C antibody or human immunodeficiency virus (HIV) 5. Any known allergy or sensitivity to adhesive dressings (e.g., Tegaderm) 6. 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 7. Participation in another interventional clinical study or trial in the past 30 days or concurrent participation in another interventional clinical study or trial 8. Subjects with poorly controlled diabetes mellitus (Hemoglobin A1c \[HbA1c\] ≥ 8%) 9. Subjects with known peripheral neuropathy, or known concomitant vascular problems (such as peripheral artery disease, arterial insufficiency, or venous hypertension) or calciphylaxis 10. Subjects with burns covering ≥ 30% of Total Body Surface Area 11. Currently on or planned to receive hyperbaric wound therapy 12. Pregnant or lactating female subjects 13. Sexually active woman of childbearing potential who is unwilling to use approved contraception method for 3 months after receiving dose of investigational drug 14. Prisoners

Design outcomes

Primary

MeasureTime frameDescription
Acute dose limiting toxicities (DLTs) of PEP / PEP-TisseelUp to 2 weeks (within the first 14 days) for each dosing cohortThe 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.
Maximum Tolerated Dose (MTD) of PEP / PEP-TisseelUp to 2 weeks (within the first 14 days) for each dosing cohortThe 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.

Secondary

MeasureTime frameDescription
Long Term safety of PEP / PEP-Tisseel6 monthsThe secondary endpoint is to determine the safety and tolerability of a single dose of PEP or PEP-Tisseel delivered at a single time point, as assessed by the occurrence of DLTs through the Day 15-182 DLT period

Other

MeasureTime frameDescription
Exploratory Endpoint6 monthsThe exploratory endpoint is to assess wound closure as defined as 100% re-epithelialization after treatment with PEP and PEP-TISSEEL.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026