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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

VC01-103 Trial 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

VC01-103 Trial 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

VC01-103 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.

Frequently Asked Questions

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

Are individuals aged 25 or older welcome in this clinical trial?

"The age range that this trial is willing to accept starts at 18 years old and ends at 65 years old."

Answered by AI

For whom is this study looking for participants?

"Up to 70 individuals between the ages of 18 and 65 who have type 1 diabetes mellitus may enroll in this study. Patients must also meet the following requirements: They must be willing and able to comply with protocol requirements, they must be male or non-pregnant women, and they should be considered an acceptable candidate for implant procedures."

Answered by AI

Can people with the required medical conditions enroll in this trial at this time?

"Unfortunately, this specific trial is not currently looking for patients. Although, it is worth noting that there are over 1300 other trials that are actively recruiting right now. This particular study was originally posted on June 25th, 2019 and was last updated on February 18th, 2022."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
Texas
California
How old are they?
18 - 65
What site did they apply to?
Atlanta Diabetes Associates
Texas Diabetes & Endocrinology
Diablo Clinical Research
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I'm hoping any type 1 Diabetes Mellitus trial will improve my blood sugars and life in general. I have had type 1 since I was 10 and I'm now 37 years old.
PatientReceived 2+ prior treatments
I've had T1D for 22 years and I've struggled with managing it since day 1. If we don't find a cure soon, i fear that this disease will be the not only myself but for millions of others. I'm tired of hearing the same old song that the cure is 5 years away. If I can help make a difference or get us closer to the cure, than I will be more than happy to do as many clinical trails that it will take. Even if I get us 1 step closer, 1 step is better than o steps.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long do screening visits take?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate Safety, Engraftment, and Efficacy of VC-01 in Subjects With T1 Diabetes Mellitus
2019. "A Study to Evaluate Safety, Engraftment, and Efficacy of VC-01 in Subjects With T1 Diabetes Mellitus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04678557.
~5 spots leftby Apr 2025
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