Diabetic Foot, Lower Limb Ischemia
Conditions
Brief summary
Mesenchymal stem cells with multidirectional differentiation potential,autologous stem cell transplantation into ischemic foot, make its differentiation to form new blood capillary, improve and restore the local blood flow.
Interventions
BIOLOGICALMesenchymal stem cells
10-20 x 10\^6 cells/20mL
Sponsors
Chinese PLA General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 78 Years
Healthy volunteers
Yes
Inclusion criteria
* the age of 30-78 years old, men and women there is no limit. * in accordance with the ministry of health in higher medical colleges and universities teaching material the sixth edition of the annals of diabetic foot diagnostic criteria. * with severe lower limb ischemia (defined as the resting state of ankle brachial index (ABI) 0.4-0.85, accompanied by resting or intermittent toe line. * treatment on a voluntary basis, and sign the informed consent.
Exclusion criteria
* with severe heart, liver, kidney, lung function failure or general condition is very poor can't tolerate the stem cell transplant. * clear over the past five years tumor markers in patients with malignant disease and blood levels increased significantly. * the prodrome of acute infectious diseases. * participated in clinical subjects within three months before test. * adherence is poor, can not complete the course.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Adverse Events | 6 months | Frequency and severity of Adverse Events |
Secondary
| Measure | Time frame |
|---|---|
| Relative Wound Area Regression of 40% or More at 6 Week | 6 week |
Other
| Measure | Time frame | Description |
|---|---|---|
| Reduced pain | 6 months after treatment | Reduced pain, measured by VAS scale and use of analgesics |
Countries
China
Contacts
Primary Contactxiaobing FU
Outcome results
None listed