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Clinical Trials/NCT02304588
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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
December 2017
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Chinese PLA General Hospital
Responsible Party
Principal Investigator
Principal Investigator

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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