Evidence map›Paper›PMID 39920220›Full record

Trial reportScientific reports2025

First-in-human exploratory trial assessing safety, feasibility, and efficacy of artificial protein (silk-elastin) in promoting healing in patients with meniscus injuries.

Masakazu Ishikawa, Shunya Tsuji, Goki Kamei, Kyohei Nakata, Akinori Nekomoto, Naofumi Hashiguchi, Tomoyuki Nakasa, Atsuo Nakamae, Naosuke Kamei, Keiichiro Inoue and 3 more

Abstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Scientific reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

13 authors.

Masakazu IshikawaDepartment of Orthopedic Surgery, Faculty of Medicine, Kagawa University, Kagawa, Japan. ishikawa.masakazu@kagawa-u.ac.jp.
Shunya TsujiDepartment of Orthopedic Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
Goki KameiDepartment of Orthopedic Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
Kyohei NakataDepartment of Orthopedic Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
Akinori NekomotoDepartment of Orthopedic Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
Naofumi HashiguchiDepartment of Orthopedic Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
Tomoyuki NakasaDepartment of Orthopedic Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
Atsuo NakamaeDepartment of Orthopedic Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
Naosuke KameiDepartment of Orthopedic Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
Keiichiro InoueSanyo Chemical Industries, Kyoto, Japan.
Shingo KawabataSanyo Chemical Industries, Kyoto, Japan.
Keiko UedaTrarnslation Research Center for Medical Innovation, Kobe, Hyogo, Japan.
Nobuo AdachiDepartment of Orthopedic Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.

Funding

Japan Agency for Medical Research and Development 20im0210222
6 · The paper itself

Abstract

Meniscal tears, especially those in avascular regions, pose a significant risk for osteoarthritis if repair fails. While meniscal repair is the preferred method for preserving knee function, it often has a high failure rate in avascular zones. This study aimed to evaluate the safety and potential efficacy of silk-elastin (SE), an artificial protein with wound-healing properties, for enhancing meniscal repair. Eight patients with meniscal tears in avascular areas underwent arthroscopic repair followed by SE application, including cases of lateral and medial tears, discoid lateral meniscus, and bucket-handle tears. No adverse events or reactions were attributed to SE. At 3 months post-surgery, clinical outcomes and repair sites were evaluated using MRI and arthroscopy. Significant improvements were observed in Lysholm and visual analog scale scores (P < 0.05), with the knee injury and osteoarthritis outcome scores showing significant improvement in the symptom subscale. MRI findings indicated one patient with grade 1 healing, three with grade 2, and four with grade 3 (unhealed). Arthroscopically, six patients demonstrated completely healed menisci, while two showed incomplete healing; none were classified as "unhealed." These findings suggest that SE is safe and may support meniscal healing in avascular zones, indicating its potential to improve repair outcomes.

Indexed as

ElastinKnee InjuriesSilkTibial Meniscus InjuriesWound HealingAdultArthroscopyFeasibility StudiesFemaleHumansMagnetic Resonance ImagingMaleMiddle AgedTreatment OutcomeYoung AdultElastinSilkArthroscopic meniscus repairArtificial proteinKnee osteoarthritisMeniscus tearNeedle arthroscopeSilk-elastin

Identifiers

PMID39920220
PMCPMC11806047

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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.