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

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2017 by Caladrius Biosciences, Inc.
Sanford Health
Information provided by (Responsible Party):
Caladrius Biosciences, Inc. Identifier:
First received: February 12, 2016
Last updated: September 18, 2017
Last verified: September 2017
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.

Condition Intervention Phase
Diabetes Mellitus Biological: CLBS03 Low Dose Biological: CLBS03 High Dose Biological: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:

Further study details as provided by Caladrius Biosciences, Inc.:

Primary Outcome Measures:
  • Mixed Meal Tolerance Test (MMTT)-stimulated C-peptide area under the curve (AUC) [ Time Frame: Week 52 ]

Secondary Outcome Measures:
  • MMTT-stimulated C-peptide AUC [ Time Frame: Week 104 ]
  • Change in hemoglobin A1c (HbA1c) [ Time Frame: Week 104 ]
  • Change in insulin usage [ Time Frame: Week 104 ]
  • Proportion of subjects with adverse events [ Time Frame: Week 104 ]

Estimated Enrollment: 111
Study Start Date: February 2016
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CLBS03 Low Dose
A single infusion of CLBS03 Low Dose, a cell product comprised of autologous, ex vivo expanded regulatory T-cells resuspended in sterile USP (United States Pharmacopoeia) infusion solution.
Biological: CLBS03 Low Dose
Experimental: CLBS03 High Dose
A single infusion of CLBS03 High Dose, a cell product comprised of autologous, ex vivo expanded regulatory T-cells resuspended in sterile USP infusion solution.
Biological: CLBS03 High Dose
Placebo Comparator: Placebo
A single infusion of placebo, consisting of the infusion solution only
Biological: Placebo


Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02691247

Contact: Christine Kotynski
Contact: Scott Volk

United States, California
Rady Children's Hospital Recruiting
San Diego, California, United States, 92123
Contact: Marla Hashiguchi, RN    858-966-8940   
Principal Investigator: Michael Gottschalk, MD, PhD         
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Christine Torok, RN    415-502-9089   
Principal Investigator: Stephen E. Gitelman, MD         
United States, Colorado
Barbara Davis Center for Diabetes Recruiting
Aurora, Colorado, United States, 80045
Contact: Ruthie Williamson    303-724-6894   
Contact: Maya Barr    303-724-8615   
Principal Investigator: Peter Gottlieb, MD         
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06519
Contact: Naomi Yama, RN    203-737-2737   
Contact: Linda Rink    203-737-4510   
Principal Investigator: Kevan C. Herold, MD         
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Miriam Cintron    352-273-5580   
Contact: Melissa Turnier    352-273-5275   
Principal Investigator: Michael J. Haller, MD         
University of Miami, Diabetes Research Institute Recruiting
Miami, Florida, United States, 33136
Contact: Della Matheson    305-243-3781   
Principal Investigator: David A. Baidal, MD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Maureen Mullen    317-278-7036   
Contact: Stephanie Woerner    317-944-2573   
Principal Investigator: Linda DiMeglio, MD, MPH         
United States, Massachusetts
Joslin Diabetes Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Brittany Resnick    888-813-8669   
Principal Investigator: Jason Gaglia, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Beth Pappenfus    612-624-2922   
Principal Investigator: Antoinette Moran, MD         
United States, Missouri
Children's Mercy Kansas City Recruiting
Kansas City, Missouri, United States, 64108
Contact: Anne Clark, RN    816-760-5592   
Principal Investigator: Mark A. Clements, MD         
United States, North Dakota
Sanford Research Recruiting
Fargo, North Dakota, United States, 58122
Contact: Sarah Jacobson, RN    701-234-6063   
Contact: Natalie Spitzer    701-234-7258   
Principal Investigator: Luis Casas, MD         
United States, Oregon
Oregon Health Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Rebecca Fitch    503-494-4739   
Contact: Kristin Jahnke    503-494-4704   
Principal Investigator: Ines Guttmann-Bauman, MD         
United States, South Dakota
Sanford Research Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Christina Huber    605-328-8741   
Contact: Megan Broadbent    605-328-8742   
Principal Investigator: Kurt Griffin, MD, PhD         
United States, Tennessee
Vanderbilt Eskind Diabetes Clinic Recruiting
Nashville, Tennessee, United States, 37232
Contact: Faith Brendle    615-875-6150   
Contact: Jordan Smith    615-936-6324   
Principal Investigator: Daniel Moore, MD         
United States, Texas
Baylor College of Medicine / Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Christopher Williams    832-824-1580   
Contact: Miriam Gonzalez    832-826-5961   
Principal Investigator: Maria Jose Redondo, MD, PhD, MPH         
Sponsors and Collaborators
Caladrius Biosciences, Inc.
Sanford Health
Study Director: Douglas Losordo, MD Caladrius Biosciences
  More Information

Responsible Party: Caladrius Biosciences, Inc. Identifier: NCT02691247     History of Changes
Other Study ID Numbers: CLBS03-P01
Study First Received: February 12, 2016
Last Updated: September 18, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Caladrius Biosciences, Inc.:
Type 1 Diabetes Mellitus
T regulatory cell
Cell therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases processed this record on September 21, 2017