Phase II Clinical Trial of CD34+ Cell Therapy to Explore Endpoint Selection and Timing in Patients With Critical Limb Ischemia

Background: A prior phase I/IIa clinical trial provided evidence for safety, feasibility and potential efficacy of i.m. injection of granulocyte colony-stimulating factor (G-CSF)-mobilized CD34+ cells in patients with critical limb ischemia (CLI). Methods and Results: A phase II trial of CD34+ cell...

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Bibliographic Details
Published in:Circulation Journal 2014, Vol.78(2), pp.490-501
Main Authors: Fujita, Yasuyuki, Kinoshita, Makoto, Furukawa, Yutaka, Nagano, Tohru, Hashimoto, Hisako, Hirami, Yasuhiko, Kurimoto, Yasuo, Arakawa, Kyosuke, Yamazaki, Kazuo, Okada, Yukikatsu, Katakami, Nobuyuki, Uno, Emiko, Matsubara, Yoshihiro, Fukushima, Masanori, Nada, Adel, Losordo, Douglas W., Asahara, Takayuki, Okita, Yutaka, Kawamoto, Atsuhiko
Format: Article
Language:English
Subjects:
Adult
Aged
Antigens, CD34
Autografts
CD34+ cell therapy
Cell- and Tissue-Based Therapy - methods
Clinical trial
Critical limb ischemia
Endothelial progenitor cells
Female
Humans
Ischemia - physiopathology
Ischemia - therapy
Lower Extremity - blood supply
Lower Extremity - physiopathology
Male
Middle Aged
Pain - physiopathology
Pain Management
Stem Cell Transplantation
Stem Cells
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Summary:Background: A prior phase I/IIa clinical trial provided evidence for safety, feasibility and potential efficacy of i.m. injection of granulocyte colony-stimulating factor (G-CSF)-mobilized CD34+ cells in patients with critical limb ischemia (CLI). Methods and Results: A phase II trial of CD34+ cell therapy was conducted in patients with CLI to explore endpoint selection and timing. No-option CLI patients (n=11) underwent i.m. transplantation of G-CSF-mobilized CD34+ cells isolated by magnetic sorting. Ischemic rest pain scales improved from week 2 vs. baseline (P
ISSN:1346-9843
1347-4820
DOI:10.1253/circj.CJ-13-0864