Status:
TERMINATED
Safety Study of Adult Stem Cells to Treat Patients With Severe Leg Artery Disease
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Critical Limb Ischemia
Arterial Occlusive Disease
Eligibility:
All Genders
21-90 years
Phase:
PHASE1
Brief Summary
Peripheral artery disease (PAD) due to leg artery blockages can result in painful leg muscles, skin ulcers and infection due to poor blood flow. In severe forms, the only treatment may be amputation. ...
Detailed Description
Lower extremity peripheral artery disease (PAD) is a common, debilitating and potentially life-threatening illness. Obstructive PAD can progress to limb-threatening ischemia with rest pain, ulcers, an...
Eligibility Criteria
Inclusion
- Ambulatory critical limb ischemia (Rutherford Score 4/5)
- Not optimal for surgical or catheter-based revascularization
- Obstructive atherosclerosis of at least 1 major artery in both limbs
- Ankle-Brachial Index \<0.6 or Absolute Ankle pressure \<60mmHg or toe pressure \<40mmHg or pulse volume recording that is flat or barely pulsatile
Exclusion
- Gangrene(Rutherford 6) or pre-existing major tissue loss
- Unstable Angina, MI, stroke, CHF (class III or IV) within 6 months of study treatment
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00913900
Start Date
May 1 2009
End Date
December 1 2013
Last Update
December 5 2014
Active Locations (1)
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1
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792