Clinical Trial Details

NCT ID: NCT02691247
Date Last Changed: September 18, 2017


Research Study Summary

A Phase 2 clinical study for patients with Diabetes Mellitus (The Sanford Project T-Rex Study)

Research Study 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)


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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Recruitment Details

8 to 17 Years
Overall Status
Lead Sponsor
Caladrius Biosciences, Inc.
37 Months
Facility Type


All ages 8 Years to 17 Years

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

  • Liver disease

  • Pregnant or breast-feeding

  • Vaccination with a live virus within 8 weeks of receipt of study drug

  • Vaccination with a killed virus within 2 weeks of receipt of study drug

  • Participation in an investigational drug study within 90 days prior to screening

  • Previously treated with a T-Reg based cell therapy

  • History of allergy to gentamicin

Site Locations (15)

Country State City Zip Facility and Contact
United States California San Diego 92123 Rady Children's Hospital
Marla Hashiguchi, RN

Michael Gottschalk, MD, PhD
Principal Investigator
United States California San Francisco 94143 University of California, San Francisco
Christine Torok, RN

Stephen E. Gitelman, MD
Principal Investigator
United States Colorado Aurora 80045 Barbara Davis Center for Diabetes
Ruthie Williamson

Peter Gottlieb, MD
Principal Investigator
United States Connecticut New Haven 06519 Yale University School of Medicine
Naomi Yama, RN

Kevan C. Herold, MD
Principal Investigator
United States Florida Gainesville 32610 University of Florida
Miriam Cintron

Michael J. Haller, MD
Principal Investigator
United States Florida Miami 33136 University of Miami, Diabetes Research Institute
Della Matheson

David A. Baidal, MD
Principal Investigator
United States Indiana Indianapolis 46202 Indiana University
Maureen Mullen

Linda DiMeglio, MD, MPH
Principal Investigator
United States Massachusetts Boston 02215 Joslin Diabetes Center
Brittany Resnick

Jason Gaglia, MD
Principal Investigator
United States Minnesota Minneapolis 55455 University of Minnesota
Beth Pappenfus

Antoinette Moran, MD
Principal Investigator
United States Missouri Kansas City 64108 Children's Mercy Kansas City
Anne Clark, RN

Mark A. Clements, MD
Principal Investigator
United States North Dakota Fargo 58122 Sanford Research
Sarah Jacobson, RN

Luis Casas, MD
Principal Investigator
United States Oregon Portland 97239 Oregon Health Science University
Rebecca Fitch

Ines Guttmann-Bauman, MD
Principal Investigator
United States South Dakota Sioux Falls 57104 Sanford Research
Christina Huber

Kurt Griffin, MD, PhD
Principal Investigator
United States Tennessee Nashville 37232 Vanderbilt Eskind Diabetes Clinic
Faith Brendle

Daniel Moore, MD
Principal Investigator
United States Texas Houston 77030 Baylor College of Medicine / Texas Children's Hospital
Christopher Williams

Maria Jose Redondo, MD, PhD, MPH
Principal Investigator


Christine Kotynski


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