Comparison of Autologous Mesenchymal Stem Cells and Mononuclear Cells on Diabetic Critical Limb Ischemia and Foot Ulcer
Condition: Autologous Transplantation; Diabetic Foot
MeSH terms: Diabetic Foot; Chronic Limb-Threatening Ischemia; Foot Ulcer; Ischemia
Study type: Interventional
Phase: Phase 1

Summary: 
      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).
    

Detailed description: 
      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
    

Intervention name(s): Symptoms and Objective Examination
Intervention type(s): Biological
Intervention description(s): 5.0*108~5.0*109 MSCs and MNCs were transplant into impaired lower limbs by intramuscular injection
Other intervention name(s): transplant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: mesenchymal stem cells; mononuclear cells