Umbilical Cord Mesenchymal Stem Cells Injection for Diabetic Foot

• Status: Unknown status
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qingdao University

Criteria

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