Safety and Efficacy of CLBS03 in Adolescents With Recent Onset Type 1 Diabetes (The Sanford Project T-Rex Study)
Public ClinicalTrials.gov record NCT02691247. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Study identification
- NCT ID
- NCT02691247
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Lisata Therapeutics, Inc.
- Industry
- Enrollment
- 113 participants
Conditions and interventions
Conditions
Interventions
- CLBS03 High Dose Biological
- CLBS03 Low Dose Biological
- Placebo Biological
Biological
Eligibility (public fields only)
- Age range
- 8 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2016
- Primary completion
- Feb 28, 2019
- Completion
- Dec 31, 2019
- Last update posted
- Jan 7, 2021
2016 – 2020
United States locations
- U.S. sites
- 15
- U.S. states
- 13
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Rady Children's Hospital | San Diego | California | 92123 | — |
| University of California, San Francisco | San Francisco | California | 94143 | — |
| Barbara Davis Center for Diabetes | Aurora | Colorado | 80045 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06519 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| University of Miami, Diabetes Research Institute | Miami | Florida | 33136 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Children's Mercy Kansas City | Kansas City | Missouri | 64108 | — |
| Sanford Research | Fargo | North Dakota | 58122 | — |
| Oregon Health Science University | Portland | Oregon | 97239 | — |
| Sanford Research | Sioux Falls | South Dakota | 57104 | — |
| Vanderbilt Eskind Diabetes Clinic | Nashville | Tennessee | 37232 | — |
| Baylor College of Medicine / Texas Children's Hospital | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02691247, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 7, 2021 · Synced Apr 29, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02691247 live on ClinicalTrials.gov.