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) ―

Japan Study Group of Peripheral Vascular Regeneration Cell Therapy (JPRCT)

Research output: Contribution to journalArticle

2 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)2165-2174
Number of pages10
JournalCirculation Journal
Volume82
Issue number8
DOIs
Publication statusPublished - 2018 Jan 1

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Peripheral Arterial Disease
Cell Transplantation
Granulocyte Colony-Stimulating Factor
Cell- and Tissue-Based Therapy
Blood Cells
Randomized Controlled Trials
Disease-Free Survival
Transplantation
Standard of Care
Control Groups
Arteriosclerosis Obliterans
Thromboangiitis Obliterans
Renal Dialysis
Disease Progression
Clinical Trials
Safety

Keywords

  • Granulocyte colony stimulating factor
  • Peripheral arterial disease
  • Peripheral blood mononuclear cells
  • Progression-free survival

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

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) ―. / Japan Study Group of Peripheral Vascular Regeneration Cell Therapy (JPRCT).

In: Circulation Journal, Vol. 82, No. 8, 01.01.2018, p. 2165-2174.

Research output: Contribution to journalArticle

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title = "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) ―",
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.",
keywords = "Granulocyte colony stimulating factor, Peripheral arterial disease, Peripheral blood mononuclear cells, Progression-free survival",
author = "{Japan Study Group of Peripheral Vascular Regeneration Cell Therapy (JPRCT)} and Takashi Horie and Seiji Yamazaki and Sayaka Hanada and Shuzo Kobayashi and Tatsuo Tsukamoto and Tetsuya Haruna and Katsuhiko Sakaguchi and Ken Sakai and Hideaki Obara and Kiyofumi Morishita and Kenichi Saigo and Yoshiaki Shintani and Kohmei Kubo and Junichi Hoshino and Teiji Oda and Eiji Kaneko and Masaharu Nishikido and Tetsuya Ioji and Hideaki Kaneda and Masanori Fukushima and Makoto Akamatsu and Yukio Ichikawa and Akaru Ishida and Chikara Iwashita and Akio Kawamura and Kazuki Mizuiri and Takeyasu Otake and Akio Sakata",
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T1 - 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) ―

AU - Japan Study Group of Peripheral Vascular Regeneration Cell Therapy (JPRCT)

AU - Horie, Takashi

AU - Yamazaki, Seiji

AU - Hanada, Sayaka

AU - Kobayashi, Shuzo

AU - Tsukamoto, Tatsuo

AU - Haruna, Tetsuya

AU - Sakaguchi, Katsuhiko

AU - Sakai, Ken

AU - Obara, Hideaki

AU - Morishita, Kiyofumi

AU - Saigo, Kenichi

AU - Shintani, Yoshiaki

AU - Kubo, Kohmei

AU - Hoshino, Junichi

AU - Oda, Teiji

AU - Kaneko, Eiji

AU - Nishikido, Masaharu

AU - Ioji, Tetsuya

AU - Kaneda, Hideaki

AU - Fukushima, Masanori

AU - Akamatsu, Makoto

AU - Ichikawa, Yukio

AU - Ishida, Akaru

AU - Iwashita, Chikara

AU - Kawamura, Akio

AU - Mizuiri, Kazuki

AU - Otake, Takeyasu

AU - Sakata, Akio

PY - 2018/1/1

Y1 - 2018/1/1

N2 - 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.

AB - 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.

KW - Granulocyte colony stimulating factor

KW - Peripheral arterial disease

KW - Peripheral blood mononuclear cells

KW - Progression-free survival

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U2 - 10.1253/circj.CJ-17-1220

DO - 10.1253/circj.CJ-17-1220

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JO - Circulation Journal

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