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ACT34-CMI -- Adult Autologous CD34+ Stem Cells

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

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 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
Primary Completion Date : March 2008
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Information from the National Library of Medicine

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

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

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): NCT00300053

  Show 26 Study Locations
Sponsors and Collaborators
Baxter Healthcare Corporation
Study Director: Baxter Healthcare Corporation One Baxter Parkway, Deerfield, IL 60015

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Suzann Hammel, Baxter Healthcare Corporation 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:

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