PEP on a Skin Graft Donor Site Wound

Phase 1

Active, not recruiting

• Conditions: Skin Graft
• Interventions: Biological: 10% PEP; Biological: 20% PEP; Drug: TISSEEL

• Registration Number: NCT04664738
• Lead Sponsor: Rion Inc.

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.

Study Timeline

• Study First Submitted: 2020-12-07
• Study First Submitted QC: 2020-12-07
• Study First Posted: 2020-12-11
• Study Start: 2021-03-16
• Status Verified: 2023-06
• Primary Completion: 2023-08-09
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-08
• Study Completion: 2024-02-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
10 % PEP only	10% PEP	Cohort 1: Subjects will receive 10% PEP to the skin graft donor wound.
20% PEP only	20% PEP	Cohort 2: Subjects will receive 20% PEP to the skin graft donor wound
20% PEP and TISSEEL	20% PEP	Cohort 3: Subjects will receive 20% PEP and TISSEEL to the skin graft donor wound.
20% PEP and TISSEEL	TISSEEL	Cohort 3: Subjects will receive 20% PEP and TISSEEL to the skin graft donor wound.

Primary Outcome Measures

Name	Time	Method
Acute dose limiting toxicities (DLTs) of PEP / PEP-Tisseel	Up to 2 weeks (within the first 14 days) for each dosing cohort	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.
Maximum Tolerated Dose (MTD) of PEP / PEP-Tisseel	Up to 2 weeks (within the first 14 days) for each dosing cohort	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.

Secondary Outcome Measures

Name	Time	Method
Long Term safety of PEP / PEP-Tisseel	6 months	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

Trial Locations

Locations (2)

International Research Partners; 🇺🇸 Doral, Florida, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States