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NCT03162926
A Safety and Tolerability Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus
Phase 1 trial testing VC-02 Combination Product (aka PEC-Direct) in Type 1 Diabetes Mellitus in 3 participants. Completed in 15 February 2018.
15 February 2018
Quick facts
| Lead sponsor | ViaCyte |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 3 |
| Start date | 5 July 2017 |
| Primary completion | 15 February 2018 |
| Estimated completion | 15 February 2018 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- VC-02 Combination Product (aka PEC-Direct)
Conditions studied
- Type 1 Diabetes Mellitus — all drugs for Type 1 Diabetes Mellitus →
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):
-
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 -
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 -
Stem Cell-Based Clinical Trials for Diabetes Mellitus.
de Klerk E, Hebrok M. · · 2021 · cited 78× · PMID 33716982 · DOI 10.3389/fendo.2021.631463 -
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 -
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 -
Therapeutic Application of Pluripotent Stem Cells: Challenges and Risks.
Martin U. · · 2017 · cited 50× · PMID 29312943 · DOI 10.3389/fmed.2017.00229 -
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 -
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:
- PubMed search for NCT03162926
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Type 1 Diabetes Mellitus
Currently open trials in the same condition.
- NCT07142252 — Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus · Phase 2 · recruiting
- NCT07296276 — Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Patients With T1DM · NA · recruiting
- NCT07409701 — Gamification Intervertion in Children With Type 1 Diabetes · NA · recruiting
- NCT07356089 — Twiist Postmarket Surveillance Study for Type 1 Diabetes · recruiting
- NCT07434154 — Evaluation of Oxidative Stress: Comparison Between Type 1 Diabetes Mellitus and Latent Autoimmune Diabetes in Adults · recruiting
Other ViaCyte trials
Trials by the same sponsor.
- NCT04678557 — A Study to Evaluate Safety, Engraftment, and Efficacy of VC-01 in Subjects With T1 Diabetes Mellitus · Phase 1, PHASE2 · terminated
- NCT03163511 — A Safety, Tolerability, and Efficacy Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and H · Phase 1, PHASE2 · completed
- NCT02939118 — One-Year Follow-up Safety Study in Subjects Previously Implanted With VC-01™ · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03162926 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by ViaCyte
- Last refreshed: 18 October 2018
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