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ACT34-CMI -- Adult Autologous CD34+ Stem Cells

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00300053
First received: March 6, 2006
Last updated: September 1, 2010
Last verified: September 2010
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Frequency of angina episodes [ Time Frame: 6 months after treatment ] [ Designated as safety issue: Yes ]

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.

  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
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Baxter Healthcare Corporation

Additional 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
Study First Received: March 6, 2006
Last Updated: September 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Baxter Healthcare Corporation:
angina

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

ClinicalTrials.gov processed this record on June 18, 2013