LL-37 — clinical evidence
Assessed outcomes with certainty ratings, contributing trials and the reasoning for each rating.
§3Clinical evidence
§3.1Cutaneous wound healing and tissue repair
Anchor outcome. Time to complete closure.
Effect as recorded. A phase 1/2 trial of intralesional LL-37 in hard-to-heal venous leg ulcers reported greater ulcer-area reduction at intermediate doses than at the highest dose; small sample; non-monotonic dose response.[1,2]
Certainty. Low certainty A genuine controlled clinical trial exists. The non-monotonic dose response is consistent with the narrow window between beneficial and cytotoxic concentrations, and the Institute records it as mechanistically informative rather than as an anomaly.
Contributing trials. LL37-PH1-2-VENOUSULCER. Full structured abstracts are published for each.
Full evidence extract for cutaneous wound healing and tissue repair · Indication assessment
§3.2Immune modulation and adjunctive immunotherapy
Anchor outcome. CD4 and CD8 counts.
Effect as recorded. No randomised human evidence for systemic immune effects; —.[2,3]
Certainty. Very low certainty —
Contributing trials. None identified. The rating reflects an absence of controlled evidence rather than conflicting evidence.
Full evidence extract for immune modulation and adjunctive immunotherapy · Indication assessment
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- D’Hondt M, Bracke N, Taevernier L, Gevaert B, Verbeke F, Wynendaele E, De Spiegeleer B. Related impurities in peptide medicines. Journal of Pharmaceutical and Biomedical Analysis 2014;101:2–30. doi:10.1016/j.jpba.2014.06.012 · PMID 25044089
- Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. Stability of protein pharmaceuticals: an update. Pharmaceutical Research 2010;27(4):544–575. doi:10.1007/s11095-009-0045-6 · PMID 20143256
- Wang W, Nema S, Teagarden D. Protein aggregation — pathways and influencing factors. International Journal of Pharmaceutics 2010;390(2):89–99. doi:10.1016/j.ijpharm.2010.02.025 · PMID 20188795
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