Injection of Autologous CD34-Positive Cells for Critical Limb Ischemia (ACT34-CLI)
This study has been completed.
Sponsor:
Losordo, Douglas, M.D.
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
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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
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 May 22, 2013