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ACT34-CMI -- Adult Autologous CD34+ Stem Cells

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ClinicalTrials.gov Identifier: NCT00300053
Recruitment Status : Completed
First Posted : March 8, 2006
Last Update Posted : September 6, 2010
Sponsor:
Information provided by:
Baxter Healthcare Corporation

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of intramyocardial injections of adult stem cells in patients with refractory chronic myocardial ischemia.

Condition or disease Intervention/treatment Phase
Myocardial Ischemia Device: stem cell injection Phase 2

Detailed Description:
This is a double-blind, prospective, randomized, placebo-controlled trial to determine the tolerability, efficacy, safety and dose range of intramyocardial injections of adult autologous CD34+ cells mobilized with granulocyte colony stimulating factor for the reduction of angina episodes in patients with refractory chronic myocardial ischemia.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-blind, Prospective, Randomized, Placebo-controlled Study to Determine the Tolerability, Efficacy, Safety, and Dose Range of Intramyocardial Injections of G-CSF Mobilized Auto--CD34+ Cells for Reduction of Angina Episodes in Patients With Refractory Chronic Myocardial Ischemia (ACT34-CMI)
Study Start Date : March 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2009

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Frequency of angina episodes [ Time Frame: 6 months after treatment ]

Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  • 21-80 years of age
  • CCS functional class III or IV chronic refractory angina
  • unsuitable for conventional revascularization

Exclusion Criteria:

  • predominant congestive heart failure
  • left ventricular ejection fraction of less than 25% at screening
  • myocardial infarction within 60 days of treatment
  • successful coronary revascularization within 6 months of study enrollment
  • history of moderate to severe aortic stenosis or prosthetic aortic valve
  • co-morbidity associated with life expectancy of less than 1 year
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00300053


  Show 26 Study Locations
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Study Director: Baxter Healthcare Corporation One Baxter Parkway, Deerfield, IL 60015
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Suzann Hammel, Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00300053     History of Changes
Other Study ID Numbers: 24779
First Posted: March 8, 2006    Key Record Dates
Last Update Posted: September 6, 2010
Last Verified: September 2010

Keywords provided by Baxter Healthcare Corporation:
angina

Additional relevant MeSH terms:
Ischemia
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Heart Diseases
 Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases