At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 113 enrolled
Drug / intervention
CLBS03 Low Dose +2 morebiological
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 Prospective Randomized Placebo-Controlled Double Blind Clinical Trial to Evaluate the Safety and Efficacy of CLBS03 (Autologous Ex Vivo Expanded Polyclonal Regulatory T-cells) in Adolescents With Recent Onset Type 1 Diabetes Mellitus (T1DM)
In Brief
A Phase 2 clinical trial evaluating CLBS03 Low Dose, CLBS03 High Dose, and 1 other intervention for Diabetes Mellitus. Completed, enrolled 113 participants across 15 sites.
Detailed Summary
This clinical trial will explore the safety and effect of autologous ex vivo expanded polyclonal regulatory T-cells on beta cell function in patients, aged 8 to 17, with recent onset T1DM. Other measures of diabetes severity and the autoimmune response underlying T1DM will also be explored. Eligible subjects will receive a single infusion of CLBS03 (high or low dose) or placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus
CountriesUnited States
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartFeb 2016
First PostedFeb 2016
Primary CompletionMar 2019
Study CompletionJan 2020
TodayJul 2026
First PostedFeb 25, 2016
Enrollment StartFeb 1, 2016
Primary CompletionMar 1, 2019
Study CompletionJan 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 10.4 years ago
Interventions
CLBS03 Low Dosebiological
CLBS03 High Dosebiological
Placebobiological