Cellular Therapy for Type 1 Diabetes Using Mesenchymal Stem Cells
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diabetes Mellitus - Type 1
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 12 years and 30 years
- Gender
- Both males and females
Description
This study seeks to find and enroll participants with new onset Type 1 diabetes (T1D) within 3 months of the first dose of insulin. T1D is an autoimmune disease in which T cells attack and destroy insulin-secreting pancreatic ? cells leading to insulin deficiency and hyperglycemia in patients. Life-...
This study seeks to find and enroll participants with new onset Type 1 diabetes (T1D) within 3 months of the first dose of insulin. T1D is an autoimmune disease in which T cells attack and destroy insulin-secreting pancreatic ? cells leading to insulin deficiency and hyperglycemia in patients. Life-long insulin therapy is the major treatment option. However, insulin therapy is not a cure and a safer and more effective therapy is needed. Mesenchymal Stromal Cells (MSCs) have emerged as a novel biopharmaceutical approach for many disorders. MSCs are a cellular product that can be derived from a patient's own body (autologous) or from a donor (allogeneic). This study will obtain MSCs from umbilical cords at the time of delivery from normal women who have been extensively screened for infectious diseases. These cells produced at the MUSC Center for Cellular therapy will be used within 3 passages after collection. Evidence from animal models and clinical trials suggests that MSC infusion suppresses autoimmune and inflammatory diseases such as T1D. One clear message from these trials is that MSCs are effective at suppressing autoimmunity and seem generally safe. This study will measure safety and efficacy of MSCs over the course of 1 year.
Tracking Information
- NCT #
- NCT04061746
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Investigators
- Principal Investigator: Hongjun Wang, PhD Medical University of South Carolina