Injection of Autologous CD34-Positive Cells for Critical Limb Ischemia - Full Text View

Sponsor:	Losordo, Douglas, M.D.
Collaborator:	Baxter Healthcare Corporation
Information provided by:	Losordo, Douglas, M.D.
ClinicalTrials.gov Identifier:	NCT00616980

Purpose

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).

Condition	Intervention	Phase
Peripheral Artery Disease Peripheral Vascular Disease Critical Limb Ischemia	Biological: Autologous Stem Cells (CD34+)	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Injection of Autologous CD34-Positive Cells for Improved Symptomatic Relief and Ischemic Wound Healing in Subjects With Moderate or High-Risk Critical Limb Ischemia

Resource links provided by NLM:

MedlinePlus related topics: Peripheral Arterial Disease Vascular Diseases

U.S. FDA Resources

Further study details as provided by Losordo, Douglas, M.D.:

Primary Outcome Measures:

Safety of Intramuscular Injection of CD34-positive cells [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Change in Rest Pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Ulcer Healing [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Functional Improvement [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Limb Salvage [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Disease Severity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Assessment of Co-morbidity [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	75
Study Start Date:	December 2007
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Biological: Autologous Stem Cells (CD34+) Intramuscular Injection
2: Active Comparator	Biological: Autologous Stem Cells (CD34+) Intramuscular Injection
3: Placebo Comparator	Biological: Autologous Stem Cells (CD34+) Intramuscular Injection

Eligibility

Ages Eligible for Study:	21 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

21-80 years of age
moderate or high-risk Critical Limb Ischemia (Rutherford Clinical Severity Score 4 or 5)
unsuitable for conventional revascularization

Exclusion Criteria:

advanced CLI (Rutherford Clinical Severity Score 6) characterized by extensive tissue loss or gangrene
advance AV block or NYHA Class III or Class IV heart failure
myocardial infarction within 3 months of treatment
successful coronary or lower extremity revascularization within 3 months of study enrollment
arterial insufficiency in the lower extremity is the result of a non-atherosclerotic disorder with the exception of thromboangitis obliterans (Buerger's Disease)
co-morbidity associated with life expectancy of less than 1 year

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616980

Locations

United States, Alabama
Cardiology, PC
Birmingham, Alabama, United States, 35211
United States, Florida
Florida Research Network LLC
Gainsville, Florida, United States, 32605
Orlando Regional Medical Center
Orlando, Florida, United States, 32806
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Mount Sinai School of Medicine Division of Vascular Surgery
New York, New York, United States, 10029
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
University Hospitals of Cleveland, Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Utah
University of Utah-Vascular Surgery Division
Salt Lake City, Utah, United States, 84132
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
United States, Wisconsin
Comprehensive Cardiovascular Care St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215

Sponsors and Collaborators

Losordo, Douglas, M.D.

Baxter Healthcare Corporation

More Information

No publications provided

Responsible Party:	Northwestern University ( Director, Feinberg Cardiovascular Research Institute )
Study ID Numbers:	11931-02
Study First Received:	January 24, 2008
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00616980 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Losordo, Douglas, M.D.:

PAD
PVD
CLI
Stem Cells

Additional relevant MeSH terms:

Pathologic Processes
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia

ClinicalTrials.gov processed this record on November 20, 2009