NCT04664738

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Rion Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Skin Graft

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-03-16
• Primary completion: 2023-08-09
• Completion: 2024-02-02
• First posted: 2020-12-11
• Last updated: 2023-09-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study