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

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:

MedlinePlus related topics: Angina Coronary Artery Disease

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

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 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):

Povsic TJ, Losordo DW, Story K, Junge CE, Schatz RA, Harrington RA, Henry TD. Incidence and clinical significance of cardiac biomarker elevation during stem cell mobilization, apheresis, and intramyocardial delivery: an analysis from ACT34-CMI. Am Heart J. 2012 Nov;164(5):689-697.e3. doi: 10.1016/j.ahj.2012.06.022.

Losordo DW, Henry TD, Davidson C, Sup Lee J, Costa MA, Bass T, Mendelsohn F, Fortuin FD, Pepine CJ, Traverse JH, Amrani D, Ewenstein BM, Riedel N, Story K, Barker K, Povsic TJ, Harrington RA, Schatz RA; ACT34-CMI Investigators. Intramyocardial, autologous CD34+ cell therapy for refractory angina. Circ Res. 2011 Aug 5;109(4):428-36. doi: 10.1161/CIRCRESAHA.111.245993. Epub 2011 Jul 7.


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:


Coronary Artery Disease Myocardial Ischemia Arterial Occlusive Diseases Arteriosclerosis	Cardiovascular Diseases Coronary Disease Heart Diseases Vascular Diseases

ClinicalTrials.gov processed this record on March 03, 2015