Multi-target gene therapy AUP1602-C to improve healing and quality of life for diabetic foot ulcer patients: a phase I, open-label, dose-finding study.

ABSTRACT:

Background

Diabetic foot ulcer (DFU) is a common and highly morbid complication of diabetes with high unmet medical needs. AUP1602-C, a topical four-in-one gene therapy medicinal product (GTMP), consisting of a Lactococcus cremoris strain that produces fibroblast growth factor-2, interleukin-4, and colony-stimulating factor-1, is a promising novel treatment for DFU.

Objectives

The aim of this first-in-human study was to investigate whether AUP1602-C is safe and effective in improving wound healing and quality of life (QoL) in patients with non-healing DFU (nhDFU), and to determine the recommended phase II dose.

Design

Phase I, single-arm, open-label, uncontrolled, dose escalation study.

Methods

The study consisted of four cohorts of patients receiving AU

SUBMITTER: Schindler C 

PROVIDER: S-EPMC11748067 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature