Evidence map›Paper›PMID 34657738›Full record

ArticleJournal of pediatric surgery2022

Long-term safety evaluation of placental mesenchymal stromal cells for in utero repair of myelomeningocele in a novel ovine model.

Sarah C Stokes, Christina M Theodorou, Jordan E Jackson, Christopher Pivetti, Priyadarsini Kumar, Kaeli J Yamashiro, Zachary J Paxton, Lizette Reynaga, Alicia Hyllen, Aijun Wang and 1 more

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of pediatric surgery, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.4field-weighted citation impact, top 34% 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

6 citing papers in PubMed, 11 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 3 institutions in 1 country.

Sarah C StokesDivision of Pediatric General, Thoracic and Fetal Surgery, Department of Surgery, University of California Davis Medical Center, 2335 Stockton Blvd, Room 5107, Sacramento, CA 95817, USA. Electronic address: scstokes@ucdavis.edu.
Christina M TheodorouDivision of Pediatric General, Thoracic and Fetal Surgery, Department of Surgery, University of California Davis Medical Center, 2335 Stockton Blvd, Room 5107, Sacramento, CA 95817, USA.
Jordan E JacksonDivision of Pediatric General, Thoracic and Fetal Surgery, Department of Surgery, University of California Davis Medical Center, 2335 Stockton Blvd, Room 5107, Sacramento, CA 95817, USA.
Christopher PivettiSurgical Bioengineering Laboratory, University of California Davis, Sacramento, CA 95817, USA.
Priyadarsini KumarSurgical Bioengineering Laboratory, University of California Davis, Sacramento, CA 95817, USA.
Kaeli J YamashiroDivision of Pediatric General, Thoracic and Fetal Surgery, Department of Surgery, University of California Davis Medical Center, 2335 Stockton Blvd, Room 5107, Sacramento, CA 95817, USA.
Zachary J PaxtonSurgical Bioengineering Laboratory, University of California Davis, Sacramento, CA 95817, USA.
Lizette ReynagaSurgical Bioengineering Laboratory, University of California Davis, Sacramento, CA 95817, USA.
Alicia HyllenSurgical Bioengineering Laboratory, University of California Davis, Sacramento, CA 95817, USA.
Aijun WangSurgical Bioengineering Laboratory, University of California Davis, Sacramento, CA 95817, USA; Shriners Hospital for Children Northern California, 3425 Stockton Blvd, Sacramento, CA 95817, USA.
Diana L FarmerDivision of Pediatric General, Thoracic and Fetal Surgery, Department of Surgery, University of California Davis Medical Center, 2335 Stockton Blvd, Room 5107, Sacramento, CA 95817, USA; Surgical Bioengineering Laboratory, University of California Davis, Sacramento, CA 95817, USA; Shriners Hospital for Children Northern California, 3425 Stockton Blvd, Sacramento, CA 95817, USA.
University of California, Davis · USUniversity of California Davis Medical Center · USShriners Hospitals for Children - Erie · US

Funding

UC Davis Clinical and Translational Science CenterUL1TR001860 · NCATS · UNIVERSITY OF CALIFORNIA AT DAVIS · PI KENYON, NICHOLAS J., LYLES, COURTNEY REES · 2016 to 2025
$47.3M
Engineered Neuroprotective Stem-Cell Exosomes for In Utero Spina Bifida TherapyR01NS115860 · NINDS · UNIVERSITY OF CALIFORNIA AT DAVIS · PI FARMER, DIANA LEE, WANG, AIJUN · 2020 to 2024
$2.5M
Fetal Tissue Engineering to Treat Spina Bifida Before BirthR01NS100761 · NINDS · UNIVERSITY OF CALIFORNIA AT DAVIS · PI WANG, AIJUN · 2017 to 2021
$1.7M
NCATS NIH HHS UL1 TR001860NINDS NIH HHS R01 NS100761NINDS NIH HHS R01 NS115860
6 · The paper itself

Abstract

purposeAugmentation of in utero myelomeningocele repair with human placental mesenchymal stromal cells seeded onto extracellular matrix (PMSC-ECM) improves motor outcomes in an ovine myelomeningocele model. This study evaluated the safety of PMSC-ECM application directly onto the fetal spinal cord in preparation for a clinical trial.

methodsLaminectomy of L5-L6 with PMSC-ECM placement directly onto the spinal cord was performed in five fetal lambs at gestational age (GA) 100-106 days. Lambs and ewes were monitored for three months following delivery. Lambs underwent magnetic resonance imaging (MRI) of the brain and spine at birth and at three months. All organs from lambs and uteri from ewes underwent histologic evaluation. Lamb spinal cords and brains and ewe placentas were evaluated for persistence of PMSCs by polymerase chain reaction for presence of human DNA.

resultsMRIs demonstrated no evidence of abnormal tissue growth or spinal cord tethering. Histological analysis demonstrated no evidence of abnormal tissue growth or treatment related adverse effects. No human DNA was identified in evaluated tissues.

conclusionThere was no evidence of abnormal tissue growth or PMSC persistence at three months following in utero application of PMSC-ECM to the spinal cord. This supports proceeding with clinical trials of PMSC-ECM for in utero myelomeningocele repair. LEVEL OF EVIDENCE: N/A TYPE OF STUDY: Basic science.

Indexed as

MeningomyeloceleMesenchymal Stem CellsAnimalsFemaleHumansPlacentaPregnancySheepSheep, DomesticUterusFetal surgeryMesenchymal stomal cellMyelomeningoceleSafetySpina bifida

Identifiers

PMID34657738
PMCPMC9415987
OpenAlexW3199946313

What OpenQuestion holds

Textmetadata
LicenceTDM
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.