At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 25 enrolled
Drug / intervention
AVT001 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1 / 2 Double-Blind, Randomized, Placebo Controlled Study of Safety, Tolerability and Potential Efficacy of AVOTRES Cell-Based Therapy (AVT001) in Patients With Type 1 Diabetes
In Brief
A Phase 2 clinical trial evaluating AVT001 and Placebo for Type 1 Diabetes Mellitus. Completed, enrolled 25 participants across 1 site.
Detailed Summary
This is a double-blind, randomized , placebo-controlled study to evaluate the safety and tolerability of AVT001, and to assess AVT001 as a potential treatment for type 1 diabetes (T1D). The trial will involve approximately 24 new-onset T1D subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedMar 2019
Enrollment StartJun 2019
Primary CompletionMay 2022
Study CompletionDec 2023
TodayJul 2026
First PostedMar 29, 2019
Enrollment StartJun 20, 2019
Primary CompletionMay 17, 2022
Study CompletionDec 19, 2023
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 7.3 years ago
Interventions
AVT001drug
autologous dendritic cell therapy
Placeboother
matched placebo