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Eligibility
for people ages 8–17
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator
Stephen E. Gitelman

Description

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.

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)

Keywords

Diabetes Mellitus T1DM Type 1 Diabetes Mellitus T regulatory cell Immunotherapy Cell therapy T-Reg

Eligibility

You can join if…

Open to people ages 8–17

  • 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

You CAN'T join if...

  • 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

Locations

  • Oregon Health Science University accepting new patients
    Portland, Oregon, 97239, United States
  • Barbara Davis Center for Diabetes accepting new patients
    Aurora, Colorado, 80045, United States
  • Sanford Research accepting new patients
    Sioux Falls, South Dakota, 57104, United States
  • Sanford Research accepting new patients
    Fargo, North Dakota, 58122, United States
  • Children's Mercy Kansas City accepting new patients
    Kansas City, Missouri, 64108, United States
  • Baylor College of Medicine / Texas Children's Hospital not yet accepting patients
    Houston, Texas, 77030, United States
  • University of Minnesota not yet accepting patients
    Minneapolis, Minnesota, 55455, United States
  • Vanderbilt Eskind Diabetes Clinic accepting new patients
    Nashville, Tennessee, 37232, United States
  • Indiana University accepting new patients
    Indianapolis, Indiana, 46202, United States
  • University of Florida accepting new patients
    Gainesville, Florida, 32610, United States
  • University of Miami, Diabetes Research Institute accepting new patients
    Miami, Florida, 33136, United States
  • Yale University School of Medicine accepting new patients
    New Haven, Connecticut, 06519, United States
  • Joslin Diabetes Center accepting new patients
    Boston, Massachusetts, 02215, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Caladrius Biosciences, Inc.
ID
NCT02691247
Phase
Phase 2
Lead Scientist
Stephen E. Gitelman
Study Type
Interventional
Last Updated
May 1, 2017
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