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

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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)

NCT02691247•Lisata Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

8 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and females aged 8 to 17 years of age
•Diagnosis of T1DM within 100 days of receipt of study drug
•Positive for at least one islet cell autoantibody
•Peak MMTT-stimulated C-peptide level \> 0.2 pmol/mL (at the screening visit)
•Weight of ≥30 kg
•Must agree to use a reliable and acceptable method of contraception for the duration of participation
•Willing and medically acceptable to postpone live vaccine immunizations for one year after infusion
•Written informed consent and written assent

Exclusion Criteria

•Hemoglobin less than the lower limit of normal
•Leukocytes \<3,000/μL; neutrophils \<1,500/μL; lymphocytes \<800/μL; platelets \<100,000/μL
•Regulatory T-cells present in peripheral blood at \<20 cells per μL
•Current or ongoing use of non-insulin pharmaceuticals (that may affect glycemic control)
•Current or anticipated use of systemic corticosteroids or other immunomodulatory drugs
•Recent serious bacterial, viral, fungal, or other opportunistic infections
•History of malignancy or serious uncontrolled cardiovascular, nervous system, pulmonary, renal, or gastrointestinal disease
•Serologic evidence of current or past viral infection: human immunodeficiency virus (HIV), Hepatitis B, Hepatitis C, and human T-lymphotropic virus (HTLV) 1/2
•Positive QuantiFERON® tuberculosis (TB) test, purified protein derivative (PPD) skin test, history of tuberculosis, or active TB infection
•Active infection with Epstein-Barr Virus or Cytomegalovirus
+7 more criteria

Locations (15)

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

Key Dates

Start Date

February 1, 2016

Primary Completion Date

March 1, 2019

Completion Date

January 1, 2020

Last Updated

January 8, 2021

Enrollment

113

ACTUAL participants

Conditions

Diabetes Mellitus

Interventions

CLBS03 Low Dose

BIOLOGICAL

CLBS03 High Dose

BIOLOGICAL

Placebo

BIOLOGICAL

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITING

Genetic Studies of Insulin and Diabetes

NCT00001987

Diabetes MellitusSevere Insulin Resistance

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 8, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

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