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NCT02691247 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of CLBS03 in Adolescents With Recent Onset Type 1 Diabetes (The Sanford Project T-Rex Study)
A Phase 2 study, sponsored by Lisata Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 113
- Enrollment target
NCT02691247: Completed Phase 2 study, sponsored by Lisata Therapeutics.
NCT02691247 is a Phase 2 study that has completed, run by Lisata Therapeutics. The registered enrollment target is 113 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02691247, a Phase 2 study, has completed, sponsored by Lisata Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 113 participants
- Enrollment target
Study 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.
Primary Outcome
The area-under-curve of sequential C-peptide concentrations (AUC-Cpep) during the mixed-meal tolerance test (MMTT) is the gold-standard method to assess residual beta-cell (ie, insulin) secretion in type 1 diabetes.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL CLBS03 Low Dose
- BIOLOGICAL CLBS03 High Dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2016-02 |
| Est. Completion | 2020-01 |
| Phase | Phase 2 |
What the finished NCT02691247 record still lists
NCT02691247 is an interventional study that assigns participants to a tested intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02691247 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02691247 about?
NCT02691247 is a clinical study titled "Safety and Efficacy of CLBS03 in Adolescents With Recent Onset Type 1 Diabetes (The Sanford Project T-Rex Study)". 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...
What is the current status of trial NCT02691247?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 113 participants. The study started on 2016-02. Estimated completion is 2020-01.
What interventions are being tested in trial NCT02691247?
The interventions under investigation include: Placebo (BIOLOGICAL), CLBS03 Low Dose (BIOLOGICAL), CLBS03 High Dose (BIOLOGICAL).
Who is sponsoring clinical trial NCT02691247?
This trial is sponsored by Lisata Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02691247's enrollment target sits among peer trials
113 631st of 2000 higher than 1,370 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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