Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2; diabetes mellitus; stem cell; safety; efficacy
Brief summary
The study is aimed to evaluate the safety and efficiency of autologous bone marrow mononuclear cell transplantation in treating selective patients with type 2 Diabetes Mellitus. We hypothesized that autologous bone marrow stem cell transplantation would promote β-cells regeneration by directly differentiated from the transplanted BMMCs or stimulate local stem cells regeneration and thus decrease or eliminate the need of exogenous insulin and improve β-cells function.
Detailed description
To study the safety and efficacy of bone marrow mononuclear cell transplantation in type 2 diabetics. According to the intervention and baseline characteristics, patients are divided into 4 arms.
Interventions
OTHERBMMCT
Bone marrow mononuclear cell transplantation via selective catheterization
Sponsors
Peking University Aerospace Center Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes mellitus * age 30-70 * stable doses of medication for at least 3 months * BMI \<35 and \>18.5
Exclusion criteria
* secondary cause for hyperglycemia * pregnancy or nursing * positive autoimmune antibody of diabetes * severe complication or concurrent diseases * active infection or febrile illness * allergy to iodine * history or signs of aortic aneurysm * history or active pancreatic diseases * known substance abuse or alcoholism or heavy smoking * not suitable for other conditions upon investigators' expertise
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| C-peptide | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| reduction of medication | 1 year |
| HbA1c | 1 year |
| adverse event | 1 year |
Countries
China
Outcome results
None listed