ACT34-CMI -- Adult Autologous CD34+ Stem Cells - Full Text View

Sponsored by:	Baxter Healthcare Corporation
Information provided by:	Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT00300053

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 II

MedlinePlus related topics: Angina

Drug Information available for: Granulocyte colony-stimulating factor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:

Frequency of angina episodes

Estimated Enrollment:	150
Study Start Date:	March 2006

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

Investigator:

Baxter Healthcare Corporation

One Baxter Parkway, Deerfield, IL 60015

More Information

Study ID Numbers:	24779
Study First Received:	March 6, 2006
Last Updated:	January 14, 2008
ClinicalTrials.gov Identifier:	NCT00300053
Health Authority:	United States: Food and Drug Administration

Keywords provided by Baxter Healthcare Corporation:

angina

Study placed in the following topic categories:

Heart Diseases
Myocardial Ischemia
Vascular Diseases
Angina Pectoris
Ischemia

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009