Evidence map›Paper›PMID 38012450›Full record

Trial reportNature biotechnology2024

Encapsulated stem cell-derived β cells exert glucose control in patients with type 1 diabetes.

Bart Keymeulen, Kaat De Groot, Daniel Jacobs-Tulleneers-Thevissen, David M Thompson, Melena D Bellin, Evert J Kroon, Mark Daniels, Richard Wang, Manasi Jaiman, Timothy J Kieffer and 2 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Nature biotechnology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03163511 (An Open-Label, First-In-Human Study Evaluating the Safety, Tolerability, and Efficacy of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and Hypoglycemia Unawareness), which is not on this map. Cited by 78 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
78citing papers in PubMed, 1 pooled it
27.9field-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.

NCT03163511 phase1 / phase2completednot on this map

An Open-Label, First-In-Human Study Evaluating the Safety, Tolerability, and Efficacy of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and Hypoglycemia Unawareness

TypeinterventionalSponsorViaCyteRan2017 to 2023Enrolled49ConditionsType 1 Diabetes Mellitus With HypoglycemiaArmsVC-02 Combination Product
3 · Its place in the literature

Who cites it

78 citing papers in PubMed, 1 synthesis or guideline pooled it, 88 citations in OpenAlex.

  1. Pooled it
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  15. Antigen-specific immunotherapy with a CD4Nature communications · 2026
    Article
  16. Article
  17. Pathogenesis and advances in immunotherapy for type 1 diabetes treatment.Biotechnology reports (Amsterdam, Netherlands) · 2026
    Review
  18. Review
  19. Review
  20. Article

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

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

12 authors at 4 institutions in 4 countries.

Bart KeymeulenDiabetes Research Center, Vrije Universiteit Brussel and Universitair Ziekenhuis Brussel, Brussels, Belgium. bart.keymeulen@uzbrussel.be.ORCID http://orcid.org/0000-0002-8671-4527
Kaat De GrootDiabetes Research Center, Vrije Universiteit Brussel and Universitair Ziekenhuis Brussel, Brussels, Belgium.ORCID http://orcid.org/0000-0003-1852-5465
Daniel Jacobs-Tulleneers-ThevissenDiabetes Research Center, Vrije Universiteit Brussel and Universitair Ziekenhuis Brussel, Brussels, Belgium.ORCID http://orcid.org/0000-0001-5758-9547
David M ThompsonDivision of Endocrinology, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.
Melena D BellinDepartment of Pediatrics and Department of Surgery, University of Minnesota Medical Center, Minneapolis, MN, USA.
Evert J KroonViaCyte Inc., San Diego, CA, USA.ORCID http://orcid.org/0000-0002-4069-3644
Mark DanielsViaCyte Inc., San Diego, CA, USA.
Richard WangViaCyte Inc., San Diego, CA, USA.ORCID http://orcid.org/0000-0003-0079-9214
Manasi JaimanViaCyte Inc., San Diego, CA, USA.
Timothy J KiefferViaCyte Inc., San Diego, CA, USA.
Howard L FoytViaCyte Inc., San Diego, CA, USA.ORCID http://orcid.org/0000-0002-5209-1261
Daniel PipeleersDiabetes Research Center, Vrije Universiteit Brussel and Universitair Ziekenhuis Brussel, Brussels, Belgium. daniel.pipeleers@vub.be.ORCID http://orcid.org/0000-0002-6440-2485
ViaCyte (United States) · USVrije Universiteit Brussel · BEUniversity of British Columbia · CAUniversity of Minnesota Medical Center · US

Funding

California Institute for Regenerative Medicine (CIRM) CLIN2-09672EC | Horizon 2020 Framework Programme (EU Framework Programme for Research and Innovation H2020) 681070Fonds Wetenschappelijk Onderzoek (Research Foundation Flanders) 11B5621NJDRF 2-SRA-201-708JDRF 2-SRA-2019-708
6 · The paper itself

Abstract

Clinical studies on the treatment of type 1 diabetes with device-encapsulated pancreatic precursor cells derived from human embryonic stem cells found that insulin output was insufficient for clinical benefit. We are conducting a phase 1/2, open-label, multicenter trial aimed at optimizing cell engraftment (ClinicalTrials.gov identifier: NCT03163511 ). Here we report interim, 1-year outcomes in one study group that received 2-3-fold higher cell doses in devices with an optimized membrane perforation pattern. β cell function was measured by meal-stimulated plasma C-peptide levels at 3-month intervals, and the effect on glucose control was assessed by continuous glucose monitoring (CGM) and insulin dosing. Of 10 patients with undetectable baseline C-peptide, three achieved levels ≥0.1 nmol l

Indexed as

Blood GlucoseDiabetes Mellitus, Type 1Insulin-Secreting CellsAdultC-PeptideFemaleHumansInsulinMaleBlood GlucoseC-PeptideInsulin

Identifiers

PMID38012450
PMCPMC11471599
OpenAlexW4389045834

What OpenQuestion holds

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Registered trials

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.