Comparison of Autologous Mesenchymal Stem Cells and Mononuclear Cells on Diabetic Critical Limb Ischemia and Foot Ulcer
Comparison of Autologous Mesenchymal Stem Cells and Mononuclear Cells on Diabetic Critical Limb Ischemia and Foot Ulcer
Objective:

 To compare the effect and safety of autologous transplantation of bone marrow mesenchymal
 stem cells(MSCs) and mononuclear cells(MNCs) on Diabetic patients with Critical Limb Ischemia
 and Foot Ulcer.

 Methods:

 patients were randomized into the A group and the B group by use of a randomization table.
 One lower limb in A group or in B group was selected randomly for MSCs or MNCs
 transplantation as MSCs or MNCs 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.Patients in both groups received the same ordinary treatment. Meanwhile, MSCs
 and MNCs were transplanted into the impaired lower limbs respectively. Follow-up index
 include: efficacy (pain,ulcer healing rate, lower limb amputation rate and ,ankle-brachial
 index,Transcutaneous oxygen pressure,magnetic resonance angiography) and safety (infection of
 the injection site, immunological rejection, and tumour generation).
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
Inclusion Criteria:

 -  Age from 40 to 70 years

 -  Type 2 diabetic patients

 -  bilateral critical limb ischemia(ABI from 0.30 to 0.60)

 -  at least with one foot ulcer

 Exclusion Criteria:

 -  dry gangrene above the ankle or moist gangrene

 -  malignant tumor

 -  severe coronary,cerebral and renal vascular disease