Patients With Intermittent Claudication Injected With ALDH Bright Cells (NCT01774097) | Clinical Trial Compass
CompletedPhase 2
Patients With Intermittent Claudication Injected With ALDH Bright Cells
United States82 participantsStarted 2013-06
Plain-language summary
The purpose of this study is to find out if aldehyde dehydrogenase bright (ALDHbr) cells taken from a patient's bone marrow can be placed safely, via intramuscular injections, into their affected calf and lower thigh muscles and improve blood flow and/or peak walking time in patients experiencing pain associated with blocked blood vessels in the leg.
Who can participate
Age range40 Years
SexALL
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Inclusion criteria
✓. Patients with atherosclerotic peripheral artery disease with classic claudication (exercise-induced pain, cramps, fatigue, or other equivalent discomfort involving large muscle groups of the leg(s) that is consistently relieved by rest) or atypical leg pain (exertional leg pain that does not begin at rest or does not resolve consistently with rest) as defined by the San Diego Claudication Questionnaire.
✓. Age ≥40 years
✓. Resting ankle-brachial index \<0.90 or a resting toe-brachial index of \<0.70 at baseline testing
✓. Presence of significant stenosis or occlusion of infrainguinal arteries including the superficial femoral artery, popliteal artery and/or infrapopliteal arteries as determined by: Duplex ultrasound imaging (occlusion or focal doubling of peak systolic velocity of one or more affected segments) OR lower extremity computed Tomography Angiography (CTA) OR lower extremity magnetic resonance angiography (MRA) OR lower extremity catheter-based contrast arteriography. Each of these noninvasive and invasive anatomic assessments will identify patients with at least a 50% stenosis in the affected segment.
Exclusion criteria
✕. Presence of any musculoskeletal disease, cardiac or pulmonary disease, or neurological disease that limits the patient's ability to walk to fulfill protocol requirements (claudication must be the consistent primary exercise limitation)
✕. Inability to complete treadmill testing per protocol requirements.
✕. Ability to walk for more than 12 minutes on the treadmill during treadmill testing.
✕. Patients who identify both legs as equivocally symptomatic or alternate between symptomatic legs on the baseline treadmill tests.
✕. Patients with critical limb ischemia (ischemic rest pain or ischemia-related non healing wounds or tissue loss (Rutherford categories 4-6).
✕. Recent (\<3 months) infrainguinal revascularization (surgery or endovascular revascularization) or revascularization planned during study period
✕. Patients with a patent infrainguinal bypass graft in the index limb, with or without evidence of a hemodynamically significant stenosis or other defect (kinking, pseudoaneurysm, or fistula). Patients with an occluded infrainguinal bypass graft or a patent aortobifemoral or femoral-femoral bypass graft are NOT excluded.
✕. Patients with \>2+ lower extremity pitting edema