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Cell Replacement Therapy

VC-01 Combination Product for Type 1 Diabetes (VC01-103 Trial)

Phase 1 & 2
Waitlist Available
Led By Manasi Jaiman, MD
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 weeks 4, 8, 12 and 26
Awards & highlights

Summary

This trial will evaluate an experimental combination product, cell replacement therapy intended to provide a functional cure to subjects with Type 1 Diabetes.

Eligible Conditions
  • Type 1 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 4, 8, 12 and 26
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 4, 8, 12 and 26 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cohort 1: The Percentage of Graft Cells Present at Post-implant Time Points Relative to Pre-clinical Models
Cohort 2: The Change in AUC (Area Under Curve) From Baseline to Week 26 in C-peptide During 4-hour MMTT

Trial Design

2Treatment groups
Experimental Treatment
Group I: Sentinel units (aka Cohort 1)Experimental Treatment1 Intervention
VC-01 Combination Product; Up to ten (10) VC-01 sentinels
Group II: Dose-finding units (aka Cohort 2)Experimental Treatment1 Intervention
VC-01 Combination Product; Up to twelve units implanted of which up to nine (9) are VC-01-DF (dose-finding) implants and the rest are VC-01 sentinels

Find a Location

Who is running the clinical trial?

ViaCyteLead Sponsor
6 Previous Clinical Trials
169 Total Patients Enrolled
Manasi Jaiman, MDPrincipal InvestigatorViaCyte, Inc.
Howard Foyt, MD, PhDPrincipal InvestigatorViaCyte, Inc.
~5 spots leftby Jul 2025