Umbilical Cord Mesenchymal Stem Cells Injection for Diabetic Foot

• Pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]
• Ankle-Brachial pressure index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
• Wound healing (wound size, wound stage) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
• Walking distance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
• Rate and extent of amputations [ Time Frame: 6 months ] [ Designated as safety issue: No ]

The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for diabetic foot is safe and effective in the management of diabetic foot ischemia, the therapeutic effect of stem cells is caused by improving blood circulation in ischemic limb which would in turn promote ulcer healing, prevent amputation of limb and relieve the Sevier pain of ischemia.

Type 2 diabetic patients with diabetic foot were enrolled and randomized to either transplanted group or control group. Patients in transplanted group received the stem cells treatment,Patients in control group received the standard treatment. After culture in vitro, umbilical cord mesenchymal stem cells should go through safety evaluation which include culture and check of pathogenic microorganisms (bacteria, mycoplasma, chlamydia, eumycete and viruses) of the cells medium and karyotype analysis of the mesenchymal stem cells. Only the safe cells were harvested and transplanted by multiple intramuscular injections into the impaired lower limbs. Follow-up index include: efficacy (pain,ulcer healing rate, lower limb amputation rate and ,ankle-brachial index,magnetic resonance angiography,electromyogram) and safety (infection of the injection site, fever, and tumour generation).

• Diabetic Foot
• Critical Limb Ischemia
• Mesenchymal Stem Cells
• Umbilical Cord

• Biological: umbilical cord mesenchymal stem cells
  5*10/7 per ischemic limb
  Other Name: mesenchymal stem cells
• Drug: Standard Therapy
  Any thing directed to improve blood perfusion in the limb example.Heparin,Antiplatelet agents etc
  Other Name: Drug therapy

• Experimental: umbilical cord mesenchymal stem cells
  Multiple intra muscular injection of mesenchymal stem cells derived from human umbilical cord.
  Intervention: Biological: umbilical cord mesenchymal stem cells
• Active Comparator: Standard Therapy
  Any therapy for diabetic foot which is routinely practiced and accepted in China
  Intervention: Drug: Standard Therapy

Inclusion Criteria:

• Diabetes mellitus Type 2
• Age 18 - 75 years
• Subject has an Ankle-brachial index < 0.9
• Subject has had previous conservative treatment which resulted in little or no improvement
• Subject has had no stem cell treatment within the past 6 months
• No sufficient response to best standard care delivered for six weeks.
• No surgical or radiological interventional option for revascularisation as confirmed by a vascular surgeon and an interventional radiologist
• Signed informed consent
• Absence of life-threatening complications from the ischemic limb
• Life expectancy more than 2 years
• Negative pregnancy test when applicable

Exclusion Criteria:

• Diabetic retinopathy
• History of neoplasm or hematological disease
• Uncontrolled high blood pressure (>180/110)
• Severe cardiac insufficiency (New York Heart Association [NYHA] IV) or ejection fraction<30%
• Malignant ventricular arrythmia
• Deep venous thrombosis during the last 3 months
• Active bacterial infection
• Body mass index > 35 Kg/m2
• Stroke or myocardial infarction during the last 3 months