Clinical trialNCT02691247CompletedPhase 2Interventional

Safety and Efficacy of CLBS03 in Adolescents With Recent Onset Type 1 Diabetes (The Sanford Project T-Rex Study)

SponsorLisata Therapeutics, Inc.Enrollment113Diabetes Mellitus

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Douglas Losordo, MD
Caladrius Biosciences
Study Director
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

15 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Rady Children'S Hospital
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
Barbara Davis Center for Diabetes
Aurora, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
University of Florida
Gainesville, Florida, United States
University of Miami, Diabetes Research Institute
Miami, Florida, United States
Indiana University
Indianapolis, Indiana, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Children'S Mercy Kansas City
Kansas City, Missouri, United States
Sanford Research
Fargo, North Dakota, United States
Oregon Health Science University
Portland, Oregon, United States
Sanford Research
Sioux Falls, South Dakota, United States
Vanderbilt Eskind Diabetes Clinic
Nashville, Tennessee, United States
Baylor College of Medicine / Texas Children'S Hospital
Houston, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

CLBS03 High DoseCLBS03 Low DosePlacebo

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 29 Feb 2016
Primary completion: 31 Mar 2019
Completion: 31 Jan 2020
Last update posted: 8 Jan 2021
Registered enrollment: 113
Registry id: NCT02691247

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Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.