Evidence mapPaperPMID 35028608Full record

Trial reportCell reports. Medicine2021

Insulin expression and C-peptide in type 1 diabetes subjects implanted with stem cell-derived pancreatic endoderm cells in an encapsulation device.

A M James Shapiro, David Thompson, Thomas W Donner, Melena D Bellin, Willa Hsueh, Jeremy Pettus, Jon Wilensky, Mark Daniels, Richard M Wang, Eugene P Brandon and 4 more

Open access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cell reports. Medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 164 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
164citing papers in PubMed, 1 pooled it
44.7field-weighted citation impact, top 1% 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

164 citing papers in PubMed, 1 synthesis or guideline pooled it, 287 citations in OpenAlex.

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104 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 8 institutions in 2 countries.

A M James ShapiroDepartment of Surgery, Faculty of Medicine, University of Alberta, Edmonton AB T6G 2E1, Canada.
David ThompsonDepartment of Medicine, University of British Columbia, Vancouver, BC V5Z 1M9, Canada.
Thomas W DonnerDivision of Endocrinology, Diabetes, and Metabolism, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA.
Melena D BellinSchulze Diabetes Institute, University of Minnesota Medical Center, Minneapolis, MN 55455, USA.
Willa HsuehDivision of Endocrinology, Diabetes and Metabolism, The Ohio State College of Medicine, Columbus, OH 43210, USA.
Jeremy PettusDepartment of Medicine, UC San Diego Health, La Jolla, CA 92037, USA.
Jon WilenskyPlastic and Reconstructive Surgery, Scripps Memorial Hospital, La Jolla, CA 92037, USA.
Mark DanielsViaCyte Inc., San Diego, CA 92121, USA.
Richard M WangViaCyte Inc., San Diego, CA 92121, USA.
Eugene P BrandonViaCyte Inc., San Diego, CA 92121, USA.
Manasi S JaimanViaCyte Inc., San Diego, CA 92121, USA.
Evert J KroonViaCyte Inc., San Diego, CA 92121, USA.
Kevin A D'AmourViaCyte Inc., San Diego, CA 92121, USA.
Howard L FoytViaCyte Inc., San Diego, CA 92121, USA.
ViaCyte (United States) · USJohns Hopkins University · USScripps Memorial Hospital · USThe Ohio State University · USUC San Diego Health System · USUniversity of Alberta · CAUniversity of British Columbia · CAUniversity of Minnesota Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

These preliminary data from an ongoing first-in-human phase 1/2, open-label study provide proof-of-concept that pluripotent stem cell-derived pancreatic endoderm cells (PEC-01) engrafted in type 1 diabetes patients become islet cells releasing insulin in a physiologically regulated fashion. In this study of 17 subjects aged 22-57 with type 1 diabetes, PEC-01 cells were implanted subcutaneously in VC-02 macroencapsulation devices, allowing for direct vascularization of the cells. Engraftment and insulin expression were observed in 63% of VC-02 units explanted from subjects at 3-12 months post-implant. Six of 17 subjects (35.3%) demonstrated positive C-peptide as early as 6 months post-implant. Most reported adverse events were related to surgical implant or explant procedures (27.9%) or to side-effects of immunosuppression (33.7%). Initial data suggest that pluripotent stem cells, which can be propagated to the desired biomass and differentiated into pancreatic islet-like tissue, may offer a scalable, renewable alternative to pancreatic islet transplants.

Indexed as

Stem Cell TransplantationAdolescentAdultAgedCells, ImmobilizedC-PeptideDiabetes Mellitus, Type 1EndodermFemaleHumansInsulinMaleMiddle AgedPancreasStem CellsYoung AdultC-PeptideInsulin

Identifiers

PMID35028608
PMCPMC8714853
OpenAlexW3214819015

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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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 Socratic graph.