Evidence map›Paper›PMID 37251631›Full record

ArticleEClinicalMedicine2023

Engineered bacteria to accelerate wound healing: an adaptive, randomised, double-blind, placebo-controlled, first-in-human phase 1 trial.

Emelie Öhnstedt, Evelina Vågesjö, Andreas Fasth, Hava Lofton Tomenius, Pia Dahg, Sofia Jönsson, Nisha Tyagi, Mikael Åström, Zhanar Myktybekova, Lovisa Ringstad and 5 more

Open access · goldAbstract read
In one paragraph

Article in EClinicalMedicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
5.5field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 40 citations in OpenAlex.

  1. Microbial volatile organic compounds and olfactory receptors in wound malodor.Frontiers in cellular and infection microbiology · 2026
    Pooled it
  2. The dual role of the microbiome in chronic wound management.Cell communication and signaling : CCS · 2026
    Review
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  7. Article
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  11. Skin microbiome and dermatologic disorders.The Journal of clinical investigation · 2025
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  16. Article
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  20. Antimicrobial activity of dietary supplements based on bacterial lysate ofFrontiers in cellular and infection microbiology · 2023
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 4 institutions in 1 country.

Emelie ÖhnstedtIlya Pharma AB, Dag Hammarskjölds Väg 30, 752 37 Uppsala, Sweden.
Evelina VågesjöIlya Pharma AB, Dag Hammarskjölds Väg 30, 752 37 Uppsala, Sweden.
Andreas FasthIlya Pharma AB, Dag Hammarskjölds Väg 30, 752 37 Uppsala, Sweden.
Hava Lofton TomeniusIlya Pharma AB, Dag Hammarskjölds Väg 30, 752 37 Uppsala, Sweden.
Pia DahgIlya Pharma AB, Dag Hammarskjölds Väg 30, 752 37 Uppsala, Sweden.
Sofia JönssonIlya Pharma AB, Dag Hammarskjölds Väg 30, 752 37 Uppsala, Sweden.
Nisha TyagiIlya Pharma AB, Dag Hammarskjölds Väg 30, 752 37 Uppsala, Sweden.
Mikael ÅströmIlya Pharma AB, Dag Hammarskjölds Väg 30, 752 37 Uppsala, Sweden.
Zhanar MyktybekovaIlya Pharma AB, Dag Hammarskjölds Väg 30, 752 37 Uppsala, Sweden.
Lovisa RingstadIlya Pharma AB, Dag Hammarskjölds Väg 30, 752 37 Uppsala, Sweden.
Margareth JorvidIlya Pharma AB, Dag Hammarskjölds Väg 30, 752 37 Uppsala, Sweden.
Peter FrankIlya Pharma AB, Dag Hammarskjölds Väg 30, 752 37 Uppsala, Sweden.
Per HedénSofiahemmet, Valhallavägen 91, 114 86 Stockholm, Sweden.
Stefan RoosSwedish University of Agricultural Sciences, Department of Molecular Sciences, Uppsala BioCenter, 750 07 Uppsala, Sweden.
Mia PhillipsonUppsala University, Department of Medical Cell Biology, 751 23 Uppsala, Sweden.
Ilya Pharma (Sweden) · SEUppsala University · SESwedish University of Agricultural Sciences · SESophiahemmet Hospital · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Impaired wound healing is a growing medical problem and very few approved drugs with documented clinical efficacy are available. CXCL12-expressing lactic acid bacteria, Methods: SITU-SAFE is an adaptive, randomised, double-blind, placebo-controlled, first-in-human phase 1 trial (EudraCT 2019-000680-24) consisting of a single (SAD) and a multiple ascending dose (MAD) part of three dose cohorts each. The study was performed at the Phase 1 Unit, Uppsala University Hospital, Uppsala, Sweden. Data in this article were collected between Sep 20th, 2019 and Oct 20th 2021. In total 240 wounds were induced on the upper arms in 36 healthy volunteers. SAD: 12 participants, 4 wounds (2/arm), MAD: 24 participants, 8 wounds (4/arm). Wounds in each participant were randomised to treatment with placebo/saline or ILP100-Topical. Findings: In all individuals and doses, ILP100-Topical was safe and well-tolerated with no systemic exposure. A combined cohort analysis showed a significantly larger proportion of healed wounds (p = 0.020) on Day 32 by multi-dosing of ILP100-Topical when compared to saline/placebo (76% (73/96) and 59% (57/96) healed wounds, respectively). In addition, time to first registered healing was shortened by 6 days on average, and by 10 days at highest dose. ILP100-Topical increased the density of CXCL12 Interpretation: The favourable safety profile and observed effects on wound healing support continued clinical development of ILP100-Topical for the treatment of complicated wounds in patients. Funding: Ilya Pharma AB (Sponsor), H2020 SME Instrument Phase II (#804438), Knut and Alice Wallenberg foundation.

Indexed as

CXCL12ILP100ImmunotherapyLimosilactobacillusPhase 1 clinical trialSITUSAFE

Identifiers

PMID37251631
PMCPMC10220316
OpenAlexW4378218648

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.