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A Study to Evaluate Safety, Engraftment, and Efficacy of VC-01 in Subjects With T1 Diabetes Mellitus (VC01-103)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04678557
Recruitment Status : Active, not recruiting
First Posted : December 22, 2020
Last Update Posted : February 21, 2022
Sponsor:
Information provided by (Responsible Party):
ViaCyte

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Combination Product: VC-01 Combination Product Phase 1 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: There are two Cohorts in this study design. Cohort 1 (Phase 1) enrolls up to 30 subjects total. After Cohort 1 enrollment is completed, Cohort 2 enrollment then occurs with up to an additional 40 subjects. A total of up to 70 subjects will be enrolled under this Phase 1/2 protocol.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Open-Label Phase 1/2 Study to Evaluate the Safety, Engraftment, and Efficacy of VC-01™Combination Product in Subjects With Type 1 Diabetes Mellitus
Actual Study Start Date : June 25, 2019
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: Sentinel units (aka Cohort 1)
VC-01 Combination Product; Up to ten (10) VC-01 sentinels
 Combination Product: VC-01 Combination Product
PEC-01 cells loaded into an Encaptra Drug Delivery System
Other Name: PEC-Encap
Experimental: Dose-finding units (aka Cohort 2)
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
 Combination Product: VC-01 Combination Product
PEC-01 cells loaded into an Encaptra Drug Delivery System
Other Name: PEC-Encap


Outcome Measures
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Primary Outcome Measures :
  1. Cohort 1: The percentage of graft cells present at post-implant time points relative to pre-clinical models [ Time Frame: Up to 26 weeks ]
    Assess via histology the potential for functional engraftment of VC-01 combination product

  2. Cohort 2: The change in AUC from baseline to Week 26 in C-peptide during 4-HR MMTT [ Time Frame: To Week 26 ]
    Evaluate the clinical efficacy of VC-01 combination product.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

• Advanced complications associated with diabetes

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04678557


Locations
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United States, California
AMCR Institute
Escondido, California, United States, 92025
Diablo Clinical Research
Walnut Creek, California, United States, 94598
United States, Georgia
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30318
United States, Texas
Texas Diabetes & Endocrinology
Austin, Texas, United States, 78731
Sponsors and Collaborators
ViaCyte
Investigators
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Principal Investigator: Howard Foyt, MD, PhD ViaCyte, Inc.
More Information
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Additional Information:

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Responsible Party: ViaCyte
ClinicalTrials.gov Identifier: NCT04678557    
Other Study ID Numbers: VC01-103
First Posted: December 22, 2020    Key Record Dates
Last Update Posted: February 21, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases