Evidence map›Paper›PMID 38278956›Full record

ArticleCommunications medicine2024

Peripheral nerve regeneration following scaffold-free conduit transplant of autologous dermal fibroblasts: a non-randomised safety and feasibility trial.

Ryosuke Ikeguchi, Tomoki Aoyama, Takashi Noguchi, Mika Ushimaru, Yoko Amino, Akiyoshi Nakakura, Noriko Matsuyama, Shiori Yoshida, Momoko Nagai-Tanima, Keiko Matsui and 5 more

Open access · goldAbstract read
In one paragraph

Article in Communications medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
3.5field-weighted citation impact, top 7% 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

15 citing papers in PubMed, 13 citations in OpenAlex.

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  11. [Research progress in auxiliary components of nerve conduit for treating peripheral nerve injuries].Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery · 2025
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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 2 institutions in 1 country.

Ryosuke IkeguchiDepartment of Rehabilitation Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan. ikeguchi@kuhp.kyoto-u.ac.jp.ORCID http://orcid.org/0000-0003-4525-7849
Tomoki AoyamaHuman Health Sciences, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Takashi NoguchiDepartment of Orthopaedic Surgery, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Mika UshimaruInstitute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan.
Yoko AminoInstitute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan.
Akiyoshi NakakuraInstitute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan.
Noriko MatsuyamaInstitute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan.
Shiori YoshidaInstitute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan.
Momoko Nagai-TanimaHuman Health Sciences, Graduate School of Medicine, Kyoto University, Kyoto, Japan.ORCID http://orcid.org/0000-0003-3972-8800
Keiko MatsuiCenter for Research and Application of Cellular Therapy, Kyoto University Hospital, Kyoto, Japan.
Yasuyuki AraiCenter for Research and Application of Cellular Therapy, Kyoto University Hospital, Kyoto, Japan.ORCID http://orcid.org/0000-0002-9662-5093
Yoko ToriiCyfuse Biomedical K.K, Tokyo, Japan.
Yudai MiyazakiCyfuse Biomedical K.K, Tokyo, Japan.
Shizuka AkiedaCyfuse Biomedical K.K, Tokyo, Japan.
Shuichi MatsudaDepartment of Orthopaedic Surgery, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Kyoto University Hospital · JPKyoto University · JP

Funding

Japan Agency for Medical Research and Development (AMED) 21lm0203121h0002
6 · The paper itself

Abstract

backgroundThe use of Bio 3D nerve conduits is a promising approach for peripheral nerve reconstruction. This study aimed to assess their safety in three patients with peripheral nerve defects in their hands.

methodsWe describe a single institution, non-blinded, non-randomised control trial conducted at Kyoto University Hospital. Eligibility criteria included severed peripheral nerve injuries or a defect in the region distal to the wrist joint not caused by a congenital anomaly; a defect with a length of ≤20 mm in a nerve with a diameter ≤2 mm; failed results of sensory functional tests; ability to register in the protocol within 6 months from the day of injury; refusal of artificial nerve or autologous nerve transplantation; age 20-60 years; and willingness to participate and provide informed written consent. Six weeks before transplantation, skin was harvested, dermal fibroblasts were isolated and expanded, and Bio 3D nerve conduits were created using a Bio 3D printer. Bio 3D nerve conduits were transplanted into the patients' nerve defects. The safety of Bio 3D nerve conduits in patients with a peripheral nerve injury in the distal part of the wrist joint were assessed over a 48-week period after transplantation.

resultsNo adverse events related to the use of Bio 3D nerve conduits were observed in any patient, and all three patients completed the trial.

conclusionsBio 3D nerve conduits were successfully used for clinical nerve reconstruction without adverse events and are a possible treatment option for peripheral nerve injuries.

Identifiers

PMID38278956
PMCPMC10817910
OpenAlexW4391256151

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Registered trials

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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.