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Study for Recently Diagnosed Type 1 Diabetes Patients

To test an investigational cell therapy to see if it is safe for use in patients with Type 1 Diabetes (T1D) and to see if T1D improves after taking it. The investigational cell therapy would be manufactured from your own blood cells and is intended to help correct an imbalance of certain types of cells found in patients with T1D. Correcting this imbalance may help slow down the worsening of T1D.

Age & Gender

  • 18 years ~ 45 years
  • Male, Female, Gender Inclusive

Visit Availability

  • Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

You will be asked to meet with members of the study team and answer questions about your health and medications. If you are assigned to a specific cohort of the study group, you will be asked to take rapamycin as instructed and keep track of the doses you take in an eDiary. This study involves a leukapheresis procedure and an infusion. It also involves a mixed-meal tolerance test, ECG, blood draws, and CGM use.

Incentives

Information provided upon request, Treatment with the investigational cell therapy product and, if in a specific cohort, rapamycin

In-person visits:
13-16
Phone or online visits:
8
Total length of participation:
about 20 months

Looking for Specific Volunteers

Able to participate:

  • you were diagnosed with Type 1 Diabetes within 120 days of screening for this study
  • you are currently on insulin therapy
  • you are willing to agree to protocol-specified contraception

Not eligible if:

  • you are pregnant, breastfeeding, or planning to become pregnant or breastfeed at any time during participation in the study
  • you have type 2 diabetes
  • you are an employee of, or an immediate family member of an employee of, the Sponsor, study site, or of a contactor/vendor for the study

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

Clinical and Translational Research Center (CTRC)
Burnett-Womack Building (UNC-Chapel Hill)
160 Dental Cir, Chapel Hill, NC 27514, USA

Secondary Visit Location

UNC Eastowne Medical Office Building
100 Eastowne Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

John Buse
Medicine-Endocrinology

Study Type

Clinical or Medical
Interventional

Study Topics

Diabetes

IRB Number

25-1241

ClinicalTrials.gov

NCT06919354

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