NCT02304588
Unknown
Phase 1
Vascular Occlusive Diseases Such as Diabetic Foot Treated With Mesenchymal Stem Cell
Chinese PLA General Hospital1 site in 1 country20 target enrollmentJanuary 2013
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Diabetic Foot
- Sponsor
- Chinese PLA General Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Frequency of Adverse Events
- Last Updated
- 11 years ago
Overview
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.
Investigators
Xiaobing Fu
Academician
Chinese PLA General Hospital
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Frequency of Adverse Events
Time Frame: 6 months
Frequency and severity of Adverse Events
Secondary Outcomes
- Relative Wound Area Regression of 40% or More at 6 Week(6 week)
Study Sites (1)
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