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Injection of Autologous CD34-Positive Cells for Critical Limb Ischemia (ACT34-CLI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00616980
Recruitment Status : Completed
First Posted : February 15, 2008
Last Update Posted : July 25, 2011
Baxter Healthcare Corporation
Information provided by:
Losordo, Douglas, M.D.

Brief Summary:
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 or disease Intervention/treatment Phase
Peripheral Artery Disease Peripheral Vascular Disease Critical Limb Ischemia Biological: CD34-positive cells Biological: Saline and 5% autologous plasma Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : December 2007
Actual Primary Completion Date : April 2010
Actual Study Completion Date : August 2010

Arm Intervention/treatment
Active Comparator: Low Dose Biological: CD34-positive cells
Active Comparator: High Dose Biological: CD34-positive cells
Placebo Comparator: Saline Biological: Saline and 5% autologous plasma

Primary Outcome Measures :
  1. Safety of Intramuscular Injection of CD34-positive cells [ Time Frame: 6 months and 1 year ]
  2. Change in Rest Pain [ Time Frame: 6 months ]
  3. Ulcer Healing [ Time Frame: 6 months ]
  4. Functional Improvement [ Time Frame: 6 months ]
  5. Limb Salvage [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Disease Severity [ Time Frame: 6 months ]
  2. Assessment of Co-morbidity [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00616980

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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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Director, Feinberg Cardiovascular Research Institute, Northwestern University Identifier: NCT00616980    
Other Study ID Numbers: STU00009937/STU00001469
11931-02 ( Other Identifier: Sponsor protocol number )
First Posted: February 15, 2008    Key Record Dates
Last Update Posted: July 25, 2011
Last Verified: July 2011
Keywords provided by Losordo, Douglas, M.D.:
Stem Cells
Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Pathologic Processes
Cardiovascular Diseases
Arterial Occlusive Diseases