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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to the month 6 visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to the month 6 visit
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
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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
65 Previous Clinical Trials
3,126 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You don't follow your current diabetes treatment plan.You have been diagnosed with type 1 diabetes for at least five years.You are physically suitable for a surgical implantation.Only men and women who are not pregnant can participate.You have a condition where you don't realize when your blood sugar is too low or your blood sugar levels are too unstable.You have had a transplant of your pancreas, kidney or islet cells.You have thyroid disease or adrenal insufficiency that is not being treated or controlled.You have well-controlled diabetes and are receiving stable treatment for it.You must be willing to use a device that monitors your blood sugar levels continuously.You have severe complications from diabetes, such as kidney disease, eye problems, foot ulcers, amputations caused by diabetes, or severe nerve damage in your extremities.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2
- Group 2: Cohort 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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