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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 baseline to the month 6 visit
Awards & highlights

Study Summary

This trial will test a new cell therapy to see if it can provide a functional cure for people with Type 1 Diabetes and Hypoglycemia Unawareness.

Eligible Conditions
  • Type 1 Diabetes Mellitus With Hypoglycemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to the month 6 visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to the month 6 visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in C-peptide for Cohort 2 subjects
Incidence of all adverse events reported for Cohort 1 subjects

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 six (6) 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?

ViaCyteLead Sponsor
6 Previous Clinical Trials
151 Total Patients Enrolled
5 Trials studying Diabetes Mellitus
100 Patients Enrolled for Diabetes Mellitus
California Institute for Regenerative Medicine (CIRM)OTHER
63 Previous Clinical Trials
3,099 Total Patients Enrolled
3 Trials studying Diabetes Mellitus
140 Patients Enrolled for Diabetes Mellitus
Horizon 2020 - European CommissionOTHER
31 Previous Clinical Trials
13,827 Total Patients Enrolled

Media Library

VC-02 Combination Product (Cell Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03163511 — Phase 1 & 2
Diabetes Mellitus Research Study Groups: Cohort 2, Cohort 1
Diabetes Mellitus 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open enrollment opportunities for this research study?

"Per the data on clinicaltrials.gov, this trial is not currently enrolling patients as it was first posted on July 6th 2017 and last updated 13 days later. However, there are 1292 other trials actively seeking participants at present."

Answered by AI

Is this research initiative accepting individuals aged 45 or older?

"To be eligible for this research trial, participants must meet the age limitations of between 18 and 65. Separately, there are 225 studies available to minors and 940 that target seniors."

Answered by AI

How many locations are administering this experiment?

"This study is actively enrolling patients across 5 centres, such as the Alpha Stem Cell Clinic in Sacramento, University of British Columbia in Vancouver and Ohio State University. Additionally, there are two more sites providing opportunities for participation."

Answered by AI

What qualifications must a participant possess in order to be eligible for this research?

"This medical trial seeks seventy-five individuals with insulin dependent diabetes mellitus aged between eighteen and sixty-five years old. Notably, potential participants should meet the following qualifications: Men and nonpregnant women, hypoglycemic unawareness or marked glycaemic volatility, eligible for implantation procedure."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
California
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
Ohio State University
How many prior treatments have patients received?
0
~6 spots leftby Apr 2025