The purpose of this study is to evaluate the safety and efficacy of intramuscular injections of adult stem cells in patients with Critical Limb Ischemia (CLI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
28
Cardiology, PC
Birmingham, Alabama, United States
Florida Research Network LLC
Gainsville, Florida, United States
Orlando Regional Medical Center
Orlando, Florida, United States
Safety of Intramuscular Injection of CD34-positive cells
Time frame: 6 months and 1 year
Change in Rest Pain
Time frame: 6 months
Ulcer Healing
Time frame: 6 months
Functional Improvement
Time frame: 6 months
Limb Salvage
Time frame: 6 months
Disease Severity
Time frame: 6 months
Assessment of Co-morbidity
Time frame: 6 months
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Northwestern University
Chicago, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mount Sinai School of Medicine Division of Vascular Surgery
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
University Hospitals of Cleveland, Case Medical Center
Cleveland, Ohio, United States
University of Utah-Vascular Surgery Division
Salt Lake City, Utah, United States
...and 2 more locations