Comparison of Autologous Transplantation of Bone Marrow Mesenchymal Stem Cells and Mononuclear Cells on Diabetic Critical Limb Ischemia and Foot Ulcer
RESEARCH DESIGN AND METHODS Written informed consent was obtained from all subjects. Type 2
diabetic patients with bilateral critical limb ischemia (ankle-brachial index, ABI from 0.30
to 0.60) and at least with one foot ulcer, but without malignant tumor or gangrene above the
ankle and/or severe coronary, cerebral and renal vascular disease, were eligible for the
participation in this trial. Eligible patients took part in this study on a voluntary basis.
They were randomized into the A and B group by use of a randomization table. One lower limb
in A group or in B group was selected randomly for BMMSCs or BMMNCs transplantation as
BMMSCs or BMMNCs group, the other lower limb in the same patient was selected for
placebo（normal saline ,NS）injection as NS group. The whole procedures of this clinical trial
were blinded to both patients and investigators.
Preparation of Human Autologous Serum Preparation of MSCs and MNCs Flow Cytometric Analysis
Examination of cells Safety Administration of therapy 5.0*108~5.0*109 MSCs and MNCs were
transplant into impaired lower limbs by intramuscular injection.
observation index and assessment guidelines Statistical analysis
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Magnetic resonance angiography
Chen bing, doctor
Endocrinology and Metabolism Department, the south west Hospital of the Third Military Medical University
China: Ethics Committee