PACE Trial

The Patients with Intermittent Claudication Injected with ALDH Bright Cells trial assessed the safety and efficacy of injecting aldehyde dehydrogenase bright cells into the affected areas of patients with claudication.

Design: Randomized, double blind, parallel assignment

Patients: 78

Centers: 9

Country: United States

Results: Change in peak walking time at 6 months was 2.1 minutes in the cell group vs. 1.2 minutes in the placebo group (difference, 0.9; 95% CI, –0.6 to 2.5). There were no differences between the groups in 6-month change in collateral artery count (weight-adjusted P = .081), peak hyperemic flow (weight-adjusted P = .835) or capillary perfusion (weight-adjusted P = .937). In patients with baseline ankle-brachial index < 0.6, cell therapy was associated with greater change in collateral artery count at 6 months (weight-adjusted P = .021).

Original Publications:
Perin EC, et al. Circulation. 2017;doi:10.1161/CIRCULATIONAHA.116.025707

Healio/Cardiology News Coverage:
PACE: ALDH bright cells fail to improve functional outcomes in claudication