PEP on a Skin Graft Donor Site Wound

Skin Graft Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04664738
• Other study ID #: PRO-00068
• Secondary ID: 18-004995
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 16, 2021
• Est. completion date: February 2, 2024

Study information

• Verified date: June 2023
• Source: Rion Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8
• Est. completion date: February 2, 2024
• Est. primary completion date: August 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Skin Graft

Intervention

Biological:
• 10% PEP
PEP is comprised of platelet derived extracellular vesicles enriched in anti-inflammatory and angiogenic growth factors.

Drug:
• TISSEEL
Fibrin sealant made from pooled human plasma

Biological:
• 20% PEP
PEP is comprised of platelet derived extracellular vesicles enriched in anti-inflammatory and angiogenic growth factors.

Locations

Country	Name	City	State
United States	International Research Partners	Doral	Florida
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Rion Inc.	ProPharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Endpoint	The exploratory endpoint is to assess wound closure as defined as 100% re-epithelialization after treatment with PEP and PEP-TISSEEL.	6 months
Primary	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
Primary	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	Long Term safety of PEP / PEP-Tisseel	The 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	6 months

External Links

•   Rion company website