Diabetes Mellitus, Diabetes Mellitus, Type 1, Mesenchymal Stem Cells, Umbilical Cord
Conditions
Keywords
Diabetes Mellitus, Diabetes Mellitus, Type 1, mesenchymal stem cells, Umbilical cord
Brief summary
The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for initial type 1 diabetes is safe and effective.
Detailed description
Type 1 diabetes mellitus (T1DM)is characterized by the autoimmune destruction of the pancreatic β cells.Patients require multiple daily insulin injections throughout their lives as well as close monitoring of their diet and blood sugar levels to prevent complications. The investigators hope umbilical cord Mesenchymal Stem Cells could not only address the need for β-cell replacement but also control of the autoimmune response to β cells.
Interventions
BIOLOGICALumbilical cord mesenchymal stem cells
Transfusion of the umbilical cord mesenchymal stem cells (2 x 107 cells) intravenously.
Sponsors
Qingdao University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of type 1 diabetes by ADA criteria less than 9 weeks. * Ability to provide written informed consent from patients or Child guardian.
Exclusion criteria
* diabetic ketoacidosis. * evidence of retinopathy at baseline. * Body Mass Index \>30. * Severe or acute organ damage. * Infectious diseases, e.g. HIV infection, or hepatitis B or C infection. * Severe psychiatric disorder. * Presence of malignancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| C peptide release test | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Exogenous insulin dose | 3 months |
| blood glucose | 3 months |
| glycosylated Hemoglobin A1c | 3 months |
| Number of severe and documented hypoglycemic events | 3 months |
| Immunologic reconstitution parameters | 3 months |
Countries
China
Outcome results
None listed