Evidence map›Paper›PMID 30213273›Full record

Trial reportStem cell research & therapy2018

Skeletal muscle-derived cell implantation for the treatment of sphincter-related faecal incontinence.

Andrea Frudinger, Rainer Marksteiner, Johann Pfeifer, Eva Margreiter, Johannes Paede, Marco Thurner

Open access · goldAbstract readClinical Trial
In one paragraph

Trial report in Stem cell research & therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
3.0field-weighted citation impact, top 9% 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

22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 45 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Review
  5. Controversies in fecal incontinence.World journal of gastroenterology · 2025
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  12. Stromal cell derived factor 1 plasmid to regenerate the anal sphincters.Journal of tissue engineering and regenerative medicine · 2022
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  17. Review
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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

6 authors at 2 institutions in 1 country.

Andrea FrudingerDepartment of Obstetrics and Gynaecology, Division of Gynaecology, Medical University of Graz, Auenbruggerplatz 14, 8036, Graz, Austria. andrea.frudinger@medunigraz.at.ORCID 0000-0002-3790-1916
Rainer MarksteinerInnovacell Biotechnologie AG, Science Park, Innsbruck, Austria.
Johann PfeiferDepartment of General Surgery, Medical University of Graz, Graz, Austria.
Eva MargreiterDepartment of General Surgery, Medical University of Graz, Graz, Austria.
Johannes PaedeB-K Ultrasound, Pascalkehre 13, 25451, Quickborn, Germany.
Marco ThurnerInnovacell Biotechnologie AG, Science Park, Innsbruck, Austria.
Medical University of Graz · ATInnovacell Biotechnologie (Austria) · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn an earlier pilot study with 10 women, we investigated a new approach for therapy of faecal incontinence (FI) due to obstetric trauma, involving ultrasound-guided injection of autologous skeletal muscle-derived cells (SMDC) into the external anal sphincter (EAS), and observed significant improvement. In the current study, we tested this therapeutic approach in an extended patient group: male and female patients suffering from FI due to EAS damage and/or atrophy. Furthermore, feasibility of lower cell counts and cryo-preserved SMDC was assessed.

methodsIn this single-centre, explorative, baseline-controlled clinical trial, each patient (n = 39; mean age 60.6 ± 13.81 years) received 79.4 ± 22.5 × 10

resultsSMDC used in this trial contained a high percentage of myogenic-expressing (CD56

conclusionsInjection of SMDCs into the EAS effectively improved sphincter-related FI due to EAS damage and/or atrophy in males and females. When confirmed in a larger, placebo-controlled trial, this minimal invasive procedure has the potential to become first-line therapy for FI.

trial registrationEU Clinical Trials Register, EudraCT 2010-023826-19 (Date of registration: 08.11.2010).

Indexed as

AgedAnal CanalCryopreservationFecal IncontinenceFemaleHumansMaleMiddle AgedMuscle Fibers, SkeletalMuscle, SkeletalPregnancyQuality of LifeTransplantation, AutologousTreatment OutcomeAnal sphincterAutologous skeletal muscle derived cellsCell therapyFaecal incontinence

Identifiers

PMID30213273
PMCPMC6136163
OpenAlexW2891224496

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.