Trials / Completed
CompletedNCT02691247
Safety and Efficacy of CLBS03 in Adolescents With Recent Onset Type 1 Diabetes (The Sanford Project T-Rex Study)
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 113 (actual)
- Sponsor
- Lisata Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 8 Years – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CLBS03 Low Dose | |
| BIOLOGICAL | CLBS03 High Dose | |
| BIOLOGICAL | Placebo |
Timeline
- Start date
- 2016-02-01
- Primary completion
- 2019-03-01
- Completion
- 2020-01-01
- First posted
- 2016-02-25
- Last updated
- 2021-01-08
- Results posted
- 2021-01-08
Locations
15 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02691247. Inclusion in this directory is not an endorsement.