Status:
UNKNOWN
Umbilical Cord Mesenchymal Stem Cells Injection for Diabetic Foot
Lead Sponsor:
Qingdao University
Conditions:
Diabetic Foot
Critical Limb Ischemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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 therapeuti...
Detailed Description
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 con...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01216865
Start Date
January 1 2011
End Date
July 1 2013
Last Update
October 13 2010
Active Locations (1)
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1
Stem Cell Research Center of Medical School Hospital of Qingdao University
Qingdao, Shandong, China, 266003