Efficacy of Autologous Bone Marrow Mononuclear Cell Transplantation in Treating Selective Type 2 Diabetes Mellitus
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Peking University Aerospace Centre Hospital
- Enrollment
- 1026
- Locations
- 1
- Primary Endpoint
- C-peptide
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Lei Lei, MD
Endocrinologist
Peking University Aerospace Centre Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
C-peptide
Time Frame: 1 year
Secondary Outcomes
- HbA1c(1 year)
- adverse event(1 year)
- reduction of medication(1 year)