Autologous Bone Marrow Mononuclear Cell Transplantation in Treating Type 2 Diabetes Mellitus
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- NCT01677013
- Lead Sponsor
- Peking University Aerospace Centre Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1026
- Type 2 diabetes mellitus
- age 30-70
- stable doses of medication for at least 3 months
- BMI <35 and >18.5
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method C-peptide 1 year
- Secondary Outcome Measures
Name Time Method HbA1c 1 year adverse event 1 year reduction of medication 1 year
Related Research Topics
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Trial Locations
- Locations (1)
Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital
🇨🇳Beijing, Beijing, China
Division of Hematology and Endocrinology, Peking University Aerospace Centre Hospital🇨🇳Beijing, Beijing, China