1. 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) ―
- Author
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Kiyofumi Morishita, Kohmei Kubo, Kenichi Saigo, Hideaki Obara, Sayaka Hanada, Masaharu Nishikido, Ken Sakai, Takashi Horie, Tatsuo Tsukamoto, Hideaki Kaneda, Tetsuya Haruna, Junichi Hoshino, Katsuhiko Sakaguchi, Masanori Fukushima, Eiji Kaneko, Teiji Oda, Seiji Yamazaki, Yoshiaki Shintani, Shuzo Kobayashi, and Tetsuya Ioji
- Subjects
Male ,medicine.medical_specialty ,030204 cardiovascular system & hematology ,Transplantation, Autologous ,Peripheral blood mononuclear cell ,Gastroenterology ,law.invention ,Peripheral Arterial Disease ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Internal medicine ,Granulocyte Colony-Stimulating Factor ,medicine ,Clinical endpoint ,Humans ,030212 general & internal medicine ,Progression-free survival ,Aged ,Peripheral Blood Stem Cell Transplantation ,Arteriosclerosis obliterans ,business.industry ,Thromboangiitis Obliterans ,Arteriosclerosis Obliterans ,General Medicine ,Middle Aged ,medicine.disease ,Hematopoietic Stem Cell Mobilization ,Progression-Free Survival ,Granulocyte colony-stimulating factor ,Clinical trial ,Transplantation ,Disease Progression ,Leukocytes, Mononuclear ,Female ,Cardiology and Cardiovascular Medicine ,business - Abstract
Background The clinical usefulness of peripheral blood (PB) mononuclear cell (MNC) transplantation in patients with peripheral arterial disease (PAD), especially in those with mild-to-moderate severity, has not been fully clarified.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. Conclusions In this first randomized, large-scale clinical trial of G-CSF-mobilized PBMNC transplantation, the cell therapy was tolerated by a variety of PAD patients. The PBMNC therapy was significantly effective for inhibiting disease progression in mild-to-moderate PAD.
- Published
- 2018