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NCT03162926

A Safety and Tolerability Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus

Completed Phase 1 Last updated 18 October 2018
What this trial tests

Phase 1 trial testing VC-02 Combination Product (aka PEC-Direct) in Type 1 Diabetes Mellitus in 3 participants. Completed in 15 February 2018.

Timeline
5 July 2017
Primary endpoint
15 February 2018
15 February 2018

Quick facts

Lead sponsorViaCyte
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment3
Start date5 July 2017
Primary completion15 February 2018
Estimated completion15 February 2018
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

ViaCyte

Who can join

Adults 18 to 65, any sex, with Type 1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this trial is to test if VC-02™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and maintained safely for up to four (4) months.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Strategies for durable β cell replacement in type 1 diabetes.
    Brusko TM, Russ HA, Stabler CL. · · 2021 · cited 107× · PMID 34326233 · DOI 10.1126/science.abh1657
  2. Immunological considerations and challenges for regenerative cellular therapies.
    Petrus-Reurer S, Romano M, Howlett S, Jones JL, et al · · 2021 · cited 97× · PMID 34172826 · DOI 10.1038/s42003-021-02237-4
  3. Stem Cell-Based Clinical Trials for Diabetes Mellitus.
    de Klerk E, Hebrok M. · · 2021 · cited 78× · PMID 33716982 · DOI 10.3389/fendo.2021.631463
  4. Current state and future evolution of pancreatic islet transplantation.
    Anazawa T, Okajima H, Masui T, Uemoto S. · · 2019 · cited 55× · PMID 30697608 · DOI 10.1002/ags3.12214
  5. Stem cells differentiation into insulin-producing cells (IPCs): recent advances and current challenges.
    Silva IBB, Kimura CH, Colantoni VP, Sogayar MC. · · 2022 · cited 53× · PMID 35840987 · DOI 10.1186/s13287-022-02977-y
  6. Therapeutic Application of Pluripotent Stem Cells: Challenges and Risks.
    Martin U. · · 2017 · cited 50× · PMID 29312943 · DOI 10.3389/fmed.2017.00229
  7. Recent Trends in Research with Human Pluripotent Stem Cells: Impact of Research and Use of Cell Lines in Experimental Research and Clinical Trials.
    Guhr A, Kobold S, Seltmann S, Seiler Wulczyn AEM, et al · · 2018 · cited 45× · PMID 30033087 · DOI 10.1016/j.stemcr.2018.06.012
  8. Towards a Functional Cure for Diabetes Using Stem Cell-Derived Beta Cells: Are We There Yet?
    Bourgeois S, Sawatani T, Van Mulders A, De Leu N, et al · · 2021 · cited 44× · PMID 33477961 · DOI 10.3390/cells10010191

Verify or expand the search:

Other recruiting trials for Type 1 Diabetes Mellitus

Currently open trials in the same condition.

Other ViaCyte trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03162926.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing