Status:
UNKNOWN
Safety and Efficacy Study of Autologous BM-MNC Processed by Two Methods for Treating Patients With Chronic Limb Ischemia
Lead Sponsor:
Xuanwu Hospital, Beijing
Collaborating Sponsors:
Thermogenesis Corp.
Hebei Medical University
Conditions:
Critical Limb Ischemia
Peripheral Arterial Disease
Eligibility:
All Genders
20-80 years
Phase:
PHASE1
PHASE2
Brief Summary
Using autologous bone marrow mononuclear cells (BM-MNC) to treat patients with chronic limb ischemia has been proved safe and effective. However, processing bone marrow by Ficoll density gradient cent...
Detailed Description
Using autologous bone marrow mononuclear cells (BM-MNC) to treat patients with chronic limb ischemia has been proved safe and effective. However, processing bone marrow by Ficoll density gradient cent...
Eligibility Criteria
Inclusion
- fontaine's stage 2-4 or resting ABI \<0.7
- age between 20 and 80 years old
- sign informed consent, voluntary subjects
- diagnosis of lower extremity arterial occlusive disease, or diabetic lower limb ischemia, or Buerger's disease
Exclusion
- poorly controlled diabetes (HBA1c\> 7.0%) and proliferative retinopathy (III-IV stage)
- malignancy history in the past five years or serum level of tumor markers elevated more than doubled
- severe heart, liver, kidney, respiratory failure or poor general condition can not tolerate BM-MNC transplantation
- serious infections (such as cellulitis, osteomyelitis, etc.)or gangrene that a major amputation cannot be avoided
- aortic or iliac or common femoral artery occlusion
- pregnant female, or reproductive age female who wants to give birth throughout the course of the study
- life expectancy less than a year
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01446055
Start Date
October 1 2011
End Date
April 1 2013
Last Update
October 12 2011
Active Locations (1)
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1
Xuan Wu Hospital
Beijing, Beijing Municipality, China