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Trial record 1 of 3 for:    act-34
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ACT34-CMI -- Adult Autologous CD34+ Stem Cells

This study has been completed.
Information provided by:
Baxter Healthcare Corporation Identifier:
First received: March 6, 2006
Last updated: September 1, 2010
Last verified: September 2010
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 Intervention Phase
Myocardial Ischemia Device: stem cell injection Phase 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:

Further study details as provided by Baxter Healthcare Corporation:

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

Estimated Enrollment: 150
Study Start Date: March 2006
Study Completion Date: March 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
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.

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
  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 identifier: NCT00300053

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

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
Study First Received: March 6, 2006
Last Updated: September 1, 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 processed this record on September 19, 2017