Transplantation of autologous endothelial progenitor cells may be beneficial in patients with idiopathic pulmonary arterial hypertension: a pilot randomized controlled trial.
OBJECTIVE
The goal of this study was to investigate the feasibility, safety, and initial clinical outcome of intravenous infusion of autologous endothelial progenitor cells (EPCs) in patients with idiopathic pulmonary arterial hypertension (IPAH).


BACKGROUND
Experimental data suggest that transplantation of EPCs attenuates monocrotaline-induced pulmonary hypertension in rats and dogs. In addition, clinical studies suggest that autologous progenitor cell transplantation is feasible and safe in patients with ischemic diseases.


METHODS
We conducted a prospective, randomized trial comparing the effects of EPC transplantation plus conventional therapy with those of conventional therapy alone in patients with IPAH. The primary end point was change in the 6-min walk distance using a standardized protocol. The secondary end points were changes in hemodynamic variables as assessed by right heart catheterization.


RESULTS
After 12 weeks of follow-up, the mean distance walked in 6 min increased by 48.2 m in the cell infusion group (from 263 +/- 42 m to 312 +/- 34 m), and an increase of 5.7 m occurred in the conventional therapy group (from 264 +/- 42 m to 270 +/- 44 m). The mean difference between the 2 groups was 42.5 m (95% confidence interval 28.7 to 56.3 m, p < 0.001). The patients in the cell infusion group also had significant improvement in mean pulmonary artery pressure, pulmonary vascular resistance, and cardiac output. There were no severe adverse events with cell infusion.


CONCLUSIONS
This preliminary study showed that intravenous infusion of autologous EPCs seemed to be feasible and safe, and might have beneficial effects on exercise capacity and pulmonary hemodynamics in patients with IPAH. (Safety and Efficacy Study of Transplantation of EPCs to Treat Idiopathic Pulmonary Arterial Hypertension; http://www.clinicaltrials.gov/ct/show/NCT00257413?order=1; NCT00257413).
Wang
Xing-Xiang
XX
Department of Cardiology, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.
Zhang
Fu-Rong
FR
Shang
Yun-Peng
YP
Zhu
Jun-Hui
JH
Xie
Xu-Dong
XD
Tao
Qian-Min
QM
Zhu
Jian-Hua
JH
Chen
Jun-Zhu
JZ
D000328:Adult; D042783:Endothelial Cells / Q000637:transplantation*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D006976:Hypertension, Pulmonary / Q000601:surgery*; D007262:Infusions, Intravenous; D008297:Male; D010865:Pilot Projects; D011446:Prospective Studies; D033581:Stem Cell Transplantation