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Cell Replacement Therapy

VC-02 for Type 1 Diabetes

Phase 1 & 2
Waitlist Available
Led By Manasi Jaiman, MD, MPH
Research Sponsored by ViaCyte
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment (visit 3, day 1) through the month 4 visit
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new treatment that involves implanting a special product under the skin to help people with Type 1 Diabetes who can't sense low blood sugar. The goal is to see if this can help their bodies produce insulin naturally and manage blood sugar levels more effectively.

Eligible Conditions
  • Diabetic Hypoglycemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment (visit 3, day 1) through the month 4 visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment (visit 3, day 1) through the month 4 visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in C-peptide for Cohort 2 Subjects
Incidence of All AEs in Cohort 1 Participants

Side effects data

From 2023 Phase 1 & 2 trial • 49 Patients • NCT03163511
100%
Anaemia
100%
Nausea
50%
Post procedural oedema
50%
Incision site cellulitis
50%
Sinusitis
50%
Incision site erythema
50%
Incision site hypoaesthesia
50%
Incision site pain
50%
Procedural nausea
50%
Decreased appetite
50%
Vomiting
50%
Anaemia postoperative
50%
Weight decreased
50%
Fatigue
50%
Procedural pain
50%
Hyperbilirubinaemia
50%
Upper respiratory tract infection
50%
Neuropathy peripheral
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1
Cohort 2

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment1 Intervention
VC-02 Combination Product; Up to twelve units implanted of which up to ten (10) are VC-02-300 implants and the rest are VC-02-20 implants.
Group II: Cohort 1Experimental Treatment1 Intervention
VC-02 Combination Product: Up to ten (10) VC-02-20 implants and up to two (2) VC-02-300 implants
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VC-02 Combination Product
2017
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedIndustry Sponsor
257 Previous Clinical Trials
35,020 Total Patients Enrolled
ViaCyteLead Sponsor
6 Previous Clinical Trials
151 Total Patients Enrolled
California Institute for Regenerative Medicine (CIRM)OTHER
69 Previous Clinical Trials
3,307 Total Patients Enrolled
Horizon 2020 - European CommissionOTHER
32 Previous Clinical Trials
14,077 Total Patients Enrolled
Gautham MarigowdaStudy DirectorVice President, Clinical Development, Vertex
Mark DanielsStudy DirectorDirector, Clinical Development
Manasi Jaiman, MD, MPHPrincipal InvestigatorChief Medical Officer, ViaCyte
2 Previous Clinical Trials
47 Total Patients Enrolled
Richard WangStudy DirectorVice President Clinical Operations

Media Library

VC-02 Combination Product (Cell Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03163511 — Phase 1 & 2
Diabetic Hypoglycemia Research Study Groups: Cohort 2, Cohort 1
Diabetic Hypoglycemia Clinical Trial 2023: VC-02 Combination Product Highlights & Side Effects. Trial Name: NCT03163511 — Phase 1 & 2
VC-02 Combination Product (Cell Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03163511 — Phase 1 & 2
~6 spots leftby Jan 2026
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