Type 1 Diabetes
Conditions
Keywords
Cord blood stem cells, Immune modulation, Stem cell educator, Autoimmunity, Islet beta cell regeneration, Type 1 diabetes
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.
Interventions
DEVICEStem Cell Educator
For the treatment, commonly the left (or right) median cubital vein, a patient's blood is passed through a Blood Cell Separator that isolates the lymphocytes from the blood according to the recommended protocol by manufacture; consequently, the collected lymphocytes were transferred into the Stem Cell Educator and treated by CB-SC; after that, the educated cells return the blood back to the patient via a dorsal vein of hand. During the MCS+ collection, the whole blood flow rate was maintained at 35 mL/min. The whole procedure was scheduled for 8 \ 9 hrs.
Sponsors
Chinese government fundings
Throne Biotechnologies Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Metabolic control | 3 months | Before treatment, test for C-peptide levels as baseline; After treatment, test C-peptide levels on the 3rd month; |
| 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. |
Countries
China, Spain
Contacts
Primary ContactYong Zhao, MD, PhD
Outcome results
None listed