{"entity": "journal", "iuid": "860b37bd55684c2cac178e9ab1cdae66", "timestamp": "2026-09-06T10:41:14.663Z", "links": {"self": {"href": "https://publications-affiliated.scilifelab.se/journal/EClinicalMedicine.json"}, "display": {"href": "https://publications-affiliated.scilifelab.se/journal/EClinicalMedicine"}}, "title": "EClinicalMedicine", "issn": "2589-5370", "issn-l": null, "publications_count": 2, "publications": [{"entity": "publication", "iuid": "8e4833c788434c98b4a84080fd0c9b60", "links": {"self": {"href": "https://publications-affiliated.scilifelab.se/publication/8e4833c788434c98b4a84080fd0c9b60.json"}, "display": {"href": "https://publications-affiliated.scilifelab.se/publication/8e4833c788434c98b4a84080fd0c9b60"}}, "title": "Engineered bacteria to accelerate wound healing: an adaptive, randomised, double-blind, placebo-controlled, first-in-human phase 1 trial.", "authors": [{"family": "\u00d6hnstedt", "given": "Emelie", "initials": "E"}, {"family": "V\u00e5gesj\u00f6", "given": "Evelina", "initials": "E"}, {"family": "Fasth", "given": "Andreas", "initials": "A"}, {"family": "Lofton Tomenius", "given": "Hava", "initials": "H"}, {"family": "Dahg", "given": "Pia", "initials": "P"}, {"family": "J\u00f6nsson", "given": "Sofia", "initials": "S"}, {"family": "Tyagi", "given": "Nisha", "initials": "N"}, {"family": "\u00c5str\u00f6m", "given": "Mikael", "initials": "M"}, {"family": "Myktybekova", "given": "Zhanar", "initials": "Z"}, {"family": "Ringstad", "given": "Lovisa", "initials": "L"}, {"family": "Jorvid", "given": "Margareth", "initials": "M"}, {"family": "Frank", "given": "Peter", "initials": "P"}, {"family": "Hed\u00e9n", "given": "Per", "initials": "P"}, {"family": "Roos", "given": "Stefan", "initials": "S"}, {"family": "Phillipson", "given": "Mia", "initials": "M"}], "type": "journal article", "published": "2023-06-00", "journal": {"title": "EClinicalMedicine", "issn": "2589-5370", "volume": "60", "pages": "102014", "issn-l": null}, "abstract": "Impaired wound healing is a growing medical problem and very few approved drugs with documented clinical efficacy are available. CXCL12-expressing lactic acid bacteria, Limosilactobacillus reuteri (ILP100-Topical), has been demonstrated to accelerate wound healing in controlled preclinical models. In this first-in-human study, the primary objective was to determine safety and tolerability of the drug candidate ILP100-Topical, while secondary objectives included assessments of clinical and biologic effects on wound healing by traditionally accepted methods and explorative and traceable assessments.\n\nSITU-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.\n\nIn 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+ cells in the wounds and local wound blood perfusion.\n\nThe favourable safety profile and observed effects on wound healing support continued clinical development of ILP100-Topical for the treatment of complicated wounds in patients.\n\nIlya Pharma AB (Sponsor), H2020 SME Instrument Phase II (#804438), Knut and Alice Wallenberg foundation.", "doi": "10.1016/j.eclinm.2023.102014", "pmid": "37251631", "labels": [], "xrefs": [{"db": "pmc", "key": "PMC10220316"}, {"db": "pii", "key": "S2589-5370(23)00191-8"}], "notes": [], "created": "2026-08-20T07:54:23.004Z", "modified": "2026-08-20T07:54:23.055Z"}, {"entity": "publication", "iuid": "5a1b7c148edf4ff999668e33764bb52f", "links": {"self": {"href": "https://publications-affiliated.scilifelab.se/publication/5a1b7c148edf4ff999668e33764bb52f.json"}, "display": {"href": "https://publications-affiliated.scilifelab.se/publication/5a1b7c148edf4ff999668e33764bb52f"}}, "title": "Vaccination and Allergic Sensitization in Early Childhood - The ALADDIN Birth Cohort.", "authors": [{"family": "Swartz", "given": "Jackie", "initials": "J"}, {"family": "Aronsson", "given": "Bernice", "initials": "B"}, {"family": "Lindblad", "given": "Frank", "initials": "F"}, {"family": "J\u00e4rnbert-Pettersson", "given": "Hans", "initials": "H"}, {"family": "Scheynius", "given": "Annika", "initials": "A"}, {"family": "Pershagen", "given": "G\u00f6ran", "initials": "G"}, {"family": "Alm", "given": "Johan", "initials": "J"}], "type": "journal article", "published": "2018-11-06", "journal": {"title": "EClinicalMedicine", "issn": "2589-5370", "volume": "4-5", "pages": "92-98", "issn-l": null}, "abstract": "The increasing incidence of allergic diseases highlights the importance of finding underlying mechanisms. Early vaccination has been suggested as one influential factor. However, it is difficult to find a study group with a large variation between subjects concerning compliance to the official vaccination program. The anthroposophic lifestyle is of interest in this context. Moreover, cohort studies show that children of families with this lifestyle run a lower risk of allergic sensitization and allergy-related disease.\n\nFrom the prospective birth cohort ALADDIN we included one group from the anthroposophic community, with restrictive attitudes concerning vaccinations, and two other groups of age-matched children with more conventional parental lifestyles. In all, 466 children were followed from birth to five years of age. Detailed vaccination data and blood samples were collected at six months, one, two, and five years. Information was also obtained on risk factors for allergy. The outcome variable, allergic sensitization was defined as allergen-specific serum IgE levels \u2265 0.35 kUA/L.\n\nIn a logistic regression model adjusted for socio-demographics and established allergy risk factors, vaccination at later age or having a lower number of injections or vaccines were associated with low OR for allergic sensitization during the first year of life. However, after adjustment for anthroposophic lifestyle, no statistically significant associations remained. The adjusted OR for sensitization at five years of age in children not receiving any vaccinations (n = 54) was 0.98 [95% CI 0.38-2.57].\n\nWe found no support for an association between early childhood vaccination and subsequent allergic sensitization. Our findings do not support scepticism towards early childhood vaccination motivated by allergy risk.", "doi": "10.1016/j.eclinm.2018.10.005", "pmid": "31193660", "labels": [], "xrefs": [{"db": "pmc", "key": "PMC6537579"}, {"db": "pii", "key": "S2589-5370(18)30042-7"}], "notes": [], "created": "2026-08-21T11:18:25.043Z", "modified": "2026-08-21T11:18:25.061Z"}], "created": "2026-08-20T07:54:23.011Z", "modified": "2026-08-20T07:54:23.011Z"}