Cellular Therapy for Type 1 Diabetes using Mesenchymal Stromal/Stem Cells
This phase 1 research study will take place at the Medical University of South Carolina located in Charleston, South Carolina. The study will evaluate stem cell therapy as an intervention for treating type 1 diabetes.
This trial aims to enroll participants with new onset type 1 diabetes within six months of their first dose of insulin.
This study will obtain stem cells from umbilical cords at the time of delivery from healthy women who have been extensively screened for infectious diseases. The cord will be processed, and cells produced. Participants will be randomized to either a treatment group (containing stem cells) or placebo group (no stem cells). The chance of being in either group is 50/50 - like a flip of a coin. The purpose of the placebo is to act as a control. Once randomized, participants will then have a one-time infusion (an IV therapy) of their assigned group.
After infusion, patients will have five follow up visits over the course of one year.
The clinical trial registration number for this study is 04061746.
This study is collaborative effort of the Department of Surgery and the Department of Medicine.
Participants are eligible if:
18-30 years old
Newly diagnosed type 1 diabetes
First insulin dose within past 6 months
Ability to maintain diabetes care for one year at the Medical University of South Carolina in Charleston, SC