Clinical and MR Imaging Assessments in Patients With Intermittent Claudication Following Injection of Bone Marrow Derived ALDH Bright Cells

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.

Stanford is now accepting new patients for this trial. Please contact Fouzia Khan at 650-736-1410 for more information.

Investigator(s):

Intervention(s):

  • biological : Placebo (vehicle)
  • biological : ALD-301

Phase: Phase 2

Eligibility

Ages Eligible For Study:

40 Years - N/A

Inclusion Criteria

1. Patients with atherosclerotic peripheral arterial 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. 2. Age ?40 years 3. Resting ankle-brachial index less than <0.90 4. 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.

External Links

Explore related trials

Contact information

Primary Contact:

Fouzia Khan 650-736-1410

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

Stanford Medicine Resources:

Footer Links: