Status:
TERMINATED
A Study to Evaluate Safety, Engraftment, and Efficacy of VC-01 in Subjects With T1 Diabetes Mellitus
Lead Sponsor:
ViaCyte
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
VC01-103 will evaluate an experimental combination product, cell replacement therapy intended to provide a functional cure to subjects with Type 1 Diabetes.
Detailed Description
This trial will test if VC-01 combination product can be implanted and maintained with safety, tolerability, and efficacy for up to Month 12/Week 52.
Eligibility Criteria
Inclusion
- Men and non-pregnant women
- Diagnosis of T1DM for a minimum of 3 years.
- Stable, optimized diabetic regimen
- Acceptable candidate for implant and explant procedures.
- Willing and able to comply with protocol requirements.
- Meet insulin dosing requirements per protocol
Exclusion
- • Advanced complications associated with diabetes
Key Trial Info
Start Date :
June 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2021
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04678557
Start Date
June 25 2019
End Date
November 19 2021
Last Update
October 18 2023
Active Locations (4)
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1
AMCR Institute
Escondido, California, United States, 92025
2
Diablo Clinical Research
Walnut Creek, California, United States, 94598
3
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30318
4
Texas Diabetes & Endocrinology
Austin, Texas, United States, 78731