Safety Study of Adult Stem Cells to Treat Patients With Severe Leg Artery Disease
Stopped early · Phase 1
Conditions studied: Critical Limb Ischemia, Arterial Occlusive Disease, Vascular Diseases
In brief
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. Adult stem cells injected into affected legs may cause new blood vessel formation and improve blood flow. The purpose of this study is to determine the feasibility and safety of injecting adult stem cells into the leg muscles of patients with severe PAD, in an attempt to improve blood flow.
Key facts
- Study ID
- NCT00913900
- Run by
- University of Wisconsin, Madison
- People needed
- 10
- Starts
- 2009-05-01
- Expected to finish
- 2013-12-01
- Last updated by the study team
- 2014-12-05
Who can join
Age: 21 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Gangrene(Rutherford 6) or pre-existing major tissue loss
- Unstable Angina, MI, stroke, CHF (class III or IV) within 6 months of study treatment
Where it is running
- University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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