Send to

Choose Destination
Am Heart J. 2014 Nov;168(5):667-73. doi: 10.1016/j.ahj.2014.07.021. Epub 2014 Jul 30.

Rationale and design for PACE: patients with intermittent claudication injected with ALDH bright cells.

Author information

Texas Heart Institute, Houston, TX.
Indiana University School of Medicine, Indianapolis, IN.
Houston Methodist Research Institute, Houston, TX.
The University of Texas Health Science Center School of Public Health, Houston, TX. Electronic address:
Cedars-Sinai Heart Institute, Los Angeles, CA.
The University of Texas Health Science Center School of Public Health, Houston, TX.
Stanford University School of Medicine, Stanford, CA.
University of Florida School of Medicine, Gainesville, FL.
University of Colorado School of Medicine, Denver, CO.
Johns Hopkins University, Baltimore, MD.
National Heart, Lung, and Blood Institute, Bethesda, MD.
Lillehei Heart Institute, Cardiovascular Division, University of Minnesota School of Medicine, Minneapolis, MN.


Peripheral artery disease (PAD) is recognized as a public health issue because of its prevalence, functional limitations, and increased risk of systemic ischemic events. Current treatments for claudication, the primary symptom in patients with PAD, have limitations. Cells identified using cytosolic enzyme aldehyde dehydrogenase (ALDH) may benefit patients with severe PAD but has not been studied in patients with claudication. PACE is a randomized, double-blind, placebo-controlled clinical trial conducted by the Cardiovascular Cell Therapy Research Network to assess the safety and efficacy of autologous bone marrow-derived ALDH(br) cells delivered by direct intramuscular injections in 80 patients with symptom-limiting intermittent claudication. Eligible patients will have a significant stenosis or occlusion of infrainguinal arteries and a resting ankle-brachial index less than 0.90 and will be randomized 1:1 to cell or placebo treatment with a 1-year follow-up. The primary end points are the change in peak walking time and leg collateral arterial anatomy, calf muscle blood flow, and tissue perfusion as determined by magnetic resonance imaging at 6 months compared with baseline. The latter 3 measurements are new physiologic lower extremity tissue perfusion and PAD imaging-based end points that may help to quantify the biologic and mechanistic effects of cell therapy. This trial will collect important mechanistic and clinical information on the safety and efficacy of ALDH(br) cells in patients with claudication and provide valuable insight into the utility of advanced magnetic resonance imaging end points.

[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Elsevier Science Icon for PubMed Central
Loading ...
Support Center