Evidence map›Paper›PMID 35090534›Full record

ArticleStem cell research & therapy2022

First-in-human autologous oral mucosal epithelial sheet transplantation to prevent anastomotic re-stenosis in congenital esophageal atresia.

Akihiro Fujino, Yasushi Fuchimoto, Yoshiyuki Baba, Nobutaka Isogawa, Takanori Iwata, Katsuhiro Arai, Makoto Abe, Nobuo Kanai, Ryo Takagi, Masanori Maeda and 1 more

Open access · goldAbstract read
In one paragraph

Article in Stem cell research & therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
7.4field-weighted citation impact, top 2% 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

13 citing papers in PubMed, 35 citations in OpenAlex.

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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

11 authors at 5 institutions in 1 country.

Akihiro FujinoDivision of Surgery, Department of Surgical Specialties, National Center for Child Health and Development, Tokyo, 157-8535, Japan.
Yasushi FuchimotoDivision of Surgery, Department of Surgical Specialties, National Center for Child Health and Development, Tokyo, 157-8535, Japan. yfuchimoto@iuhw.ac.jp.
Yoshiyuki BabaDivision of Pedodontics and Orthodontics, Department of Surgical Specialties, National Center for Child Health and Development, Tokyo, 157-8535, Japan.
Nobutaka IsogawaDivision of Pedodontics and Orthodontics, Department of Surgical Specialties, National Center for Child Health and Development, Tokyo, 157-8535, Japan.
Takanori IwataDepartment of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, 113-8510, Japan.
Katsuhiro AraiDivision of Gastroenterology, Department of Medical Subspecialties, National Center for Child Health and Development, Tokyo, 157-8535, Japan.
Makoto AbeDepartment of General Medicine, Kasaoka Division, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, 700-8558, Japan.
Nobuo KanaiHealthy Aging Innovation Center, Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology, Tokyo, 173-0015, Japan.
Ryo TakagiInstitute of Advanced Biomedical Engineering and Science, Tokyo Women's Medical University, Tokyo, 162-8666, Japan.
Masanori MaedaMakeWay LLC, Saitama, 350-0461, Japan.
Akihiro UmezawaCenter for Regenerative Medicine, National Center for Child Health and Development Research Institute, Tokyo, 157-8535, Japan.
National Center For Child Health and Development · JPOkayama University · JPTokyo Medical and Dental University · JPTokyo Metropolitan Geriatric Hospital · JPTokyo Women's Medical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCongenital esophageal atresia postoperative anastomotic stricture occurs in 30-50% of cases. Patients with severe dysphagia are treated with endoscopic balloon dilatation (EBD) and/or local injection of steroids, but many patients continue to experience frequent stricture. In this study, we investigated the transplantation of autologous oral mucosa-derived cell sheets (epithelial cell sheets) as a prophylactic treatment for congenital esophageal atresia postoperative anastomotic stricture.

methodsEpithelial cell sheets were fabricated from a patient's oral epithelial tissue, and their safety was confirmed by quality control tests. The epithelial cell sheets were transported under controlled conditions from the fabrication facility to the transplantation facility and successfully transplanted onto the lacerations caused by EBD using a newly developed transplantation device for pediatric patients. The safety of the transplantation was confirmed by follow-up examinations over 48 weeks.

resultsThe dates that EBD was performed were recorded for one year before and after epithelial cell sheet transplantation, and the intervals (in days) were evaluated. For about 6 months after transplantation, the intervals between EBDs were longer than in the year before transplantation. The patients were also aware of a reduction in dysphagia after transplantation.

conclusionsThese results suggest that cell sheet transplantation may be effective in preventing anastomotic stricture after surgery for congenital esophageal atresia, but the effect was temporary and limited in this case. Although we chose a very severe case for the first human clinical study, it may be possible to obtain a more definitive effect if the transplantation is performed before the disease becomes so severe. Future studies are needed to identify cases in which cell sheet transplantation is most effective and to determine the appropriate timeframes for transplantation.

trial registrationUMIN, UMIN000034566, registered 19 October 2018, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039393 .

Indexed as

Esophageal AtresiaEsophageal StenosisChildConstriction, PathologicHumansMouth MucosaRetrospective StudiesTreatment OutcomeAnastomotic stenosisCell sheet transplantationCongenital esophageal atresiaEpithelial cell sheetRegenerative therapySomatic stem cells

Identifiers

PMID35090534
PMCPMC8796492
OpenAlexW4221089868

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.