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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 is a Phase 2 study that has completed, run by Lisata Therapeutics. The registered enrollment target is 113 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02691247
The ClinicalTrials.gov registry entry for NCT02691247 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 113 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lisata Therapeutics, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02691247 reports 0 study locations.
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.
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