Stem Cell Educator Therapy in Type 1 Diabetes
- Conditions
- Type 1 Diabetes
- Interventions
- Device: Stem Cell Educator
- Registration Number
- NCT01350219
- Lead Sponsor
- Throne Biotechnologies Inc.
- Brief Summary
The translational potential to the clinical applications of cord blood stem cells has increased enormously in recent years, mainly because of its unique advantages including no risk to the donor, no ethical issues, low risk of graft-versus-host disease (GVHD), rapid availability, and large resource worldwide. Human cord blood contains several types of stem cells such as the umbilical cord blood-derived multipotent stem cells (CB-SC). CB-SC possess multiple biological properties including the expression of embryonic stem (ES) cell characteristics, giving rise to different types of cells and immune modulation. Specifically, CB-SC can function as an immune modulator that can lead to control of the immune responses, which could in turn be used as a new approach to overcome the autoimmunity of Type 1 diabetes (T1D) in patients1 and nonobese diabetic (NOD) mice. Here, the investigators develop a novel Stem Cell Educator therapy by using CB-SC and explore the therapeutic effectiveness of Educator therapy in T1D patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Patients were screened for enrollment in the study if both clinical signs and laboratory tests meet the diagnosis standards of American Diabetes Association 2010. Other key inclusion criteria were presence of at least one autoantibody to the pancreatic islet β cells.
- Exclusion criteria were any clinically significant diseases in liver, kidney, and heart. Additional exclusion criteria were no pregnancy, no immunosuppressive medication, no viral diseases or diseases associated with immunodeficiency.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cord blood stem cell Stem Cell Educator Human cord blood-derived multipotent stem cells (CB-SC) display unique phenotypes, such as the expression of embryonic stem (ES) cell markers, multipotential of differentiations, very low immunogenecity, and immune modulations.
- Primary Outcome Measures
Name Time Method Autoimmune control 30 days post treatment Before treatment, test autoimmune-related markers as baseline; After treatment for 30 days, repeat testing autoimmune-related markers.
- Secondary Outcome Measures
Name Time Method Analysis of islet beta cell function 6 months 1. Test for C-peptide levels on the 6th month;
2. Full evaluation of islet beta cell function after one year.Metabolic control 3 months Before treatment, test for C-peptide levels as baseline; After treatment, test C-peptide levels on the 3rd month;
Trial Locations
- Locations (4)
General Hospital of Jinan Military Command
🇨🇳Jinan, Shandong, China
The First Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Asturias, Spain
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China