Evidence map›Paper›PMID 31792260›Full record

ArticleScientific reports2019

BioSphincters to treat Fecal Incontinence in Nonhuman Primates.

Prabhash Dadhich, Jaime L Bohl, Riccardo Tamburrini, Elie Zakhem, Christie Scott, Nancy Kock, Erin Mitchell, John Gilliam, Khalil N Bitar

Open access · goldAbstract read
In one paragraph

Article in Scientific reports, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.9field-weighted citation impact, top 24% 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

3 citing papers in PubMed, 10 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
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

9 authors at 4 institutions in 1 country.

Prabhash DadhichWake Forest Institute for Regenerative Medicine, Wake Forest School of Medicine, Winston Salem, NC, USA.
Jaime L BohlDepartment of Surgery, Wake Forest School of Medicine, Winston Salem, NC, USA.
Riccardo TamburriniDepartment of Surgery, Wake Forest School of Medicine, Winston Salem, NC, USA.
Elie ZakhemWake Forest Institute for Regenerative Medicine, Wake Forest School of Medicine, Winston Salem, NC, USA.
Christie ScottWake Forest Institute for Regenerative Medicine, Wake Forest School of Medicine, Winston Salem, NC, USA.
Nancy KockDepartment of Pathology, Section on Comparative Medicine, Wake Forest School of Medicine, Winston Salem, NC, USA.
Erin MitchellAnimal Resources Program, Wake Forest Baptist Health, Winston Salem, NC, USA.
John GilliamSection on Gastroenterology, Wake Forest School of Medicine, Winston Salem, NC, USA.
Khalil N BitarWake Forest Institute for Regenerative Medicine, Wake Forest School of Medicine, Winston Salem, NC, USA. kbitar@wakehealth.edu.
Wake Forest University · USAtrium Health Wake Forest Baptist · USForest Institute · USMotility (United States) · US

Funding

BioSphincter to Treat Fecal Incontinence. Phase 1/2 Clinical Trial. SBIR Phase IIBR44DK105593 · NIDDK · CELLF-BIO INC · PI BITAR, KHALIL N · 2018 to 2021
$4.1M
Implantation of Bioengineered Intrinsically Innervated Internal Anal Sphincter (BioSphincter) to Treat Fecal IncontinenceR42DK105593 · NIDDK · CELLF-BIO INC · PI BITAR, KHALIL N · 2015 to 2017
$1.4M
NIDDK NIH HHS R42 DK105593NIDDK NIH HHS R44 DK105593
6 · The paper itself

Abstract

Loss of anorectal resting pressure due to internal anal sphincter (IAS) dysfunctionality causes uncontrolled fecal soiling and leads to passive fecal incontinence (FI). The study is focused on immediate and long-term safety and potential efficacy of bioengineered IAS BioSphincters to treat passive FI in a clinically relevant large animal model of passive FI. Passive FI was successfully developed in Non-Human Primates (NHPs) model. The implantation of autologous intrinsically innervated functional constructs resolved the fecal soiling, restored the resting pressure and Recto Anal Inhibitory Reflex (RAIR) within 1-month. These results were sustained with time, and efficacy was preserved up to 12-months. The histological studies validated manometric results with the regeneration of a well-organized neuro-muscular population in IAS. The control groups (non-treated and sham) remained affected by poor anal hygiene, lower resting pressure, and reduced RAIR throughout the study. The pathological assessment of implants, blood, and the vital organs confirmed biocompatibility without any adverse effect after implantation. This regenerative approach of implanting intrinsically innervated IAS BioSphincters has the potential to offer a better quality of life to the patients suffering from FI.

Indexed as

Anal CanalBioprosthesisAnimalsBioengineeringDisease Models, AnimalFecal IncontinenceHumansMacaca fascicularisMaleProsthesis Implantation

Identifiers

PMID31792260
PMCPMC6888838
OpenAlexW2989615521

What OpenQuestion holds

Textmetadata
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.