Complicated, hard-to-heal wounds are a growing medical problem and there are currently only two drugs approved with proven efficacy. In a new study on humans, researchers show that treatment with a specific type of modified lactic acid bacteria works well and has a positive effect on the healing of wounds.
In several controlled preclinical models, the research team behind the new study has previously demonstrated accelerated wound healing after treatment on the skin using lactic acid bacteria, or Limosilactobacillus reuteri, genetically modified to produce the chemokine CXCL12 (ILP100-Topical).
36 healthy volunteers were included in the study with a total of 240 induced wounds studied. The study’s design and methodology are described in more detail below.
The results show that treatment using ILP100-Topical was safe and well tolerated among all individuals and doses, and neither ILP100 nor CXCL12 could be detected in locations beyond the wounds. A significantly higher proportion of healed wounds was seen on day 32 using multi-dose ILP100-Topical compared to saline and placebo and 59% healed wounds respectively when the results from the multi-dose-treated wounds were pooled. The mechanism of action of ILP100-Topical was also confirmed when the treatment resulted in increased CXCL12-positive cells in the wounds, as well as increased blood flow around the wounds during the healing phase.
“Our study shows that bacteria modified to produce and deliver human protein for local effects can be used as drugs to accelerate the healing of wounds. This is the first time this has been shown in controlled human studies, and it can be expected that the effect is greater in patients with diseases that negatively affect wound healing,” explains Mia Phillipson, Professor at the Department of Medical Cell Biology at Uppsala University.
The favorable safety profile and the beneficial effects on wound healing observed here support further clinical development of ILP100-Topical for the treatment of complex and hard-to-heal wounds in patients, which is already under way.
Emelie Öhnstedt, Evelina Vågesjö, Andreas Fasth, Hava Lofton Tomenius, Pia Dahg, Sofia Jönsson, Nisha Tyagi, Mikael Åström, Zhanar Myktybekova, Lovisa Ringstad, Margareth Jorvid, Peter Frank, Per Hedén, Stefan Roos, Mia Phillipson. Engineered bacteria to accelerate wound healing: an adaptive, randomised, double-blind, placebo-controlled, first-in-human phase 1 trial. eClinicalMedicine, 2023; 60: 102014 DOI: 10.1016/j.eclinm.2023.102014
Uppsala University. “New type of drug candidate effectively accelerates wound healing in clinical study.” ScienceDaily. ScienceDaily, 30 May 2023. <www.sciencedaily.com/releases/2023/05/230530125408.htm>.
Photo by Teslariu Mihai