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

NCT02691247 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2021-01-08

Study results available
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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

BIOLOGICAL

CLBS03 Low Dose

BIOLOGICAL

CLBS03 High Dose

BIOLOGICAL

Placebo

Sponsors & Collaborators

  • Sanford Health

    collaborator OTHER

  • California Institute for Regenerative Medicine (CIRM)

    collaborator OTHER

  • Lisata Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Douglas Losordo, MD · Caladrius Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2019-03-31
Completion
2020-01-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02691247 on ClinicalTrials.gov