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

This study has been completed.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by:
Losordo, Douglas, M.D.
ClinicalTrials.gov Identifier:
NCT00616980
First received: January 24, 2008
Last updated: July 21, 2011
Last verified: July 2011
  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: CD34-positive cells
Biological: Saline and 5% autologous plasma
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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 and 1 year ] [ 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 ]

Enrollment: 28
Study Start Date: December 2007
Study Completion Date: August 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
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, see Learn About Clinical Studies.

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 by Losordo, Douglas, M.D.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Feinberg Cardiovascular Research Institute, Northwestern University
ClinicalTrials.gov Identifier: NCT00616980     History of Changes
Other Study ID Numbers: STU00009937/STU00001469, 11931-02
Study First Received: January 24, 2008
Last Updated: July 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Losordo, Douglas, M.D.:
PAD
PVD
CLI
Stem Cells

Additional relevant MeSH terms:
Ischemia
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Pathologic Processes
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on July 29, 2014