ACT34-CMI -- Adult Autologous CD34+ Stem Cells - Tabular View

Tracking Information

First Received Date ^ICMJE

March 6, 2006

Last Updated Date

October 28, 2009

Start Date ^ICMJE

March 2006

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Frequency of angina episodes

Change History

Complete list of historical versions of study NCT00300053 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

ACT34-CMI -- Adult Autologous CD34+ Stem Cells

Official Title ^ICMJE

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)

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.

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Myocardial Ischemia

Intervention ^ICMJE

Device: stem cell injection

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

150

Completion Date

March 2009

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

21 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00300053

Responsible Party

Peter Adams, Baxter Healthcare Corporation

Study ID Numbers ^ICMJE

24779

Study Sponsor ^ICMJE

Baxter Healthcare Corporation

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Baxter Healthcare Corporation

One Baxter Parkway, Deerfield, IL 60015

Information Provided By

Baxter Healthcare Corporation

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP