Abstract 13688: Randomized, Double-Blind, Placebo-Controlled Pilot Trial of Autologous CD34+ Cell Therapy for Severe Intermittent Claudication: Interim Results
Background: Surgical bypass techniques and percutaneous catheter-based interventions may be used to successfully revascularize the limbs of patients with claudication. In many patients, however, the anatomic extent and distribution of arterial occlusion is too severe to permit relief of pain. Limited medical therapy is available for these pts.
Methods: A phase IIa randomized, double-blind, placebo-controlled clinical trial of autologous CD34+ stem cell (CD34) therapy was performed in pts with Rutherford class 3 at 3 centers in US. 3 treatment groups: placebo, low (1x10^5 CD34/kg body wt) and high dose (1x10^6 CD34/kg). All pts underwent mobilization with GCSF 5 mcg/kg/day SC for 5 d, followed by apheresis on d5 followed by selection for CD34 with Isolex 300i device. CD34 were injected IM at 8 locations in the ischemic limb. Placebo injections consisted of identical volumes of the diluent only.
Results: A total of 17 pts have been randomized, completed the injection procedure and completed the 12 mo evaluation. Mean age of pts is 65.6(range 55-75), 3 female and 14 male. At 12 mo the mean increase in peak walking time(min) was 0.2±0.7 in control, 3.4±1.6 in low dose and 5.1±2.6 in hi dose. The mean increase in claudication onset time was 0.5±1.5 in control, 0.9±1.1 in low dose and 4.7±2.1 in hi dose. At 1 yr no pt had death, MI or stroke. One pt had DVT and one had vascular access complication.
Conclusions: A single administration of unmodified, autologous CD34 cell therapy was associated with improved peak walking time and claudication onset time in pts with severe claudication who are not suitable candidates for revascularization. These data support the performance of additional clinical trials of CD34 cell therapy for claudication.
- © 2011 by American Heart Association, Inc.