Type 1 Diabetes: Age 8 to 17 Years Within 100 Days of Diabetes Diagnosis (“The Sanford Project: T-Rex Study”)


Study Name: “The Sanford Project: T-Rex Study” - Exploratory Study of CLBS03 in Adolescents with Recent Onset T1DM

Protocol Title: A Prospective Randomized Placebo-Controlled Double Blind Clinical Trial to Evaluate the Safety and Efficacy of CLBS03 (Autologous Ex Vivo Expanded Polyclonal CD4+CD25+CD127lo/-FOXP3+ Regulatory T-cells [Tregs]) in Adolescents with Recent Onset Type 1 Diabetes Mellitus

Investigational Product: CLBS03 (Autologous Ex Vivo Expanded Polyclonal CD4+CD25+CD127lo/-FOXP3+ Regulatory T-cells [Tregs])

Study Sponsors: Caladrius Biosciences
Principal Investigator: Stephen E. Gitelman, MD

What is this study about? UCSF is conducting a study to test the T-regulatory (Treg) cell-based therapy called CLBS03, using a patient’s own enhanced cells, to see if it is safe and effective in preserving β-cell (insulin-making cells) function in adolescents recently diagnosed with type 1 diabetes mellitus (T1DM). At the time of T1DM diagnosis, up to 20% of the patient’s insulin producing beta cells remain in the pancreas and, if protected from immune destruction, can be saved, and restored to function, thus regaining glycemic control and decreasing long-term risks of related complications. Restoration of beta cells' viability and function can also potentially improve the patient’s quality of life by decreasing the patient’s dependence on insulin injections, and risk for major low blood sugar events and other long term complications.

Who can sign up for this study? Participants must be 8 to 17 years old and have been diagnosed with type 1 diabetes mellitus (T1DM) within the past 100 days.

In addition, participants cannot have any of the following conditions:

  • No active infection
  • No history of liver disease
  • No history of cancer
  • No pregnancy or breastfeeding
  • Weight <30kg (66lbs)

What will happen in this study? All volunteers will undergo a screening visit where they will be asked questions about their medical history, undergo a physical exam, and provide blood and urine for additional tests. Participants who meet eligibility criteria and are enrolled will donate approximately a unit of blood, which will be used to multiply their own Regulatory T-cells (Tregs). Participants will receive one dose of multiplied Tregs or placebo, administered by intravenous (IV) infusion. You will be randomly chosen to be in a group. You cannot choose which group you will be in. Neither you nor the study team will know which group you are in.

All participants will be monitored for 2 years to assess their overall diabetes health and to perform laboratory testing to determine the effects of the treatment to their immune system and beta cells. This will require several visits to UCSF for laboratory testing during this period. Blood will be drawn at each visit for lab work.

Additional Study Info: http://www.caladrius.com/product-candidates/clbs03/

How long will this study last? Each participant will be followed for approximately 2 years.

Reimbursement: You will not be charged for any of the study treatments and may be eligible for reimbursement for your time and travel expenses.

For more information please contact: Please contact UCSF Pediatric Endocrinology Type 1 Diabetes Clinical Research Team, phone: 844-813-8273 (toll-free) or email clinicalresearch@diabetes.ucsf.edu