Injection of Autologous CD34-Positive Cells for Critical Limb Ischemia

Peripheral Artery Disease Clinical Trial

— ACT34-CLI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00616980
• Other study ID #: STU00009937/STU00001469
• Secondary ID: 11931-02
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 24, 2008
• Last updated: July 21, 2011
• Start date: December 2007
• Est. completion date: August 2010

Study information

• Verified date: July 2011
• Source: Losordo, Douglas, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Ischemia
• Peripheral Arterial Disease
• Peripheral Artery Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Biological:
• CD34-positive cells

• CD34-positive cells

• Saline and 5% autologous plasma

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Losordo, Douglas, M.D.	Baxter Healthcare Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Intramuscular Injection of CD34-positive cells		6 months and 1 year
Primary	Change in Rest Pain		6 months
Primary	Ulcer Healing		6 months
Primary	Functional Improvement		6 months
Primary	Limb Salvage		6 months
Secondary	Disease Severity		6 months
Secondary	Assessment of Co-morbidity		6 months