학술논문
Outcome From a Randomized Controlled Clinical Trial ― Improvement of Peripheral Arterial Disease by Granulocyte Colony-Stimulating Factor-Mobilized Autologous Peripheral-Blood-Mononuclear Cell Transplantation (IMPACT) ―
Document Type
Journal Article
Author
Eiji Kaneko; Hideaki Kaneda; Hideaki Obara; Junichi Hoshino; Katsuhiko Sakaguchi; Ken Sakai; Kenichi Saigo; Kiyofumi Morishita; Kohmei Kubo; Masaharu Nishikido; Masanori Fukushima; Sayaka Hanada; Seiji Yamazaki; Shuzo Kobayashi; Takashi Horie; Tatsuo Tsukamoto; Teiji Oda; Tetsuya Haruna; Tetsuya Ioji; Yoshiaki Shintani; for the Japan Study Group of Peripheral Vascular Regeneration Cell Therapy (JPRCT)
Source
Circulation Journal. 2018, 82(8):2165
Subject
Language
English
ISSN
1346-9843
1347-4820
1347-4820
Abstract
Methods and Results:A randomized clinical trial was conducted to evaluate the efficacy and safety of granulocyte colony-stimulating factor (G-CSF)-mobilized PBMNC transplantation in patients with PAD (Fontaine stage II–IV and Rutherford category 1–5) caused by arteriosclerosis obliterans or Buerger’s disease. The primary endpoint was progression-free survival (PFS). In total, 107 subjects were enrolled. At baseline, Fontaine stage was II/III in 82 patients and IV in 21, and 54 patients were on hemodialysis. A total of 50 patients had intramuscular transplantation of PBMNC combined with standard of care (SOC) (cell therapy group), and 53 received SOC only (control group). PFS tended to be improved in the cell therapy group than in the control group (P=0.07). PFS in Fontaine stage II/III subgroup was significantly better in the cell therapy group than in the control group. Cell therapy-related adverse events were transient and not serious.