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A Randomized, Controlled Pilot Study of Autologous CD34+ Cell Therapy for Critical Limb Ischemia
Author(s) -
Douglas W. Losordo,
Melina R. Kibbe,
Farrell O. Mendelsohn,
William A. Marston,
Vickie R. Driver,
Mel J. Sharafuddin,
Victoria Teodorescu,
Bret N. Wiechmann,
Charles S. Thompson,
Larry W. Kraiss,
Teresa L. Carman,
Suhail Dohad,
Paul P. Huang,
Candice Junge,
Kenneth Story,
Tara Weistroffer,
Tina Thorne,
Meredith Millay,
John Paul Runyon,
Robert M. Schainfeld
Publication year - 2012
Publication title -
circulation cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.621
H-Index - 95
eISSN - 1941-7632
pISSN - 1941-7640
DOI - 10.1161/circinterventions.112.968321
Subject(s) - medicine , critical limb ischemia , randomized controlled trial , stem cell therapy , ischemia , cell therapy , limb ischemia , surgery , vascular disease , stem cell , transplantation , arterial disease , biology , genetics
Critical limb ischemia portends a risk of major amputation of 25% to 35% within 1 year of diagnosis. Preclinical studies provide evidence that intramuscular injection of autologous CD34+ cells improves limb perfusion and reduces amputation risk. In this randomized, double-blind, placebo-controlled pilot study, we evaluated the safety and efficacy of intramuscular injections of autologous CD34+ cells in subjects with moderate or high-risk critical limb ischemia, who were poor or noncandidates for surgical or percutaneous revascularization (ACT34-CLI).

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