ACT34-CMI -- Adult Autologous CD34+ Stem Cells
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ClinicalTrials.gov Identifier: NCT00300053 |
Recruitment Status
:
Completed
First Posted
: March 8, 2006
Last Update Posted
: September 6, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Myocardial Ischemia | Device: stem cell injection | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
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) |
Study Start Date : | March 2006 |
Actual Primary Completion Date : | March 2008 |
Actual Study Completion Date : | March 2009 |
- Frequency of angina episodes [ Time Frame: 6 months after treatment ]

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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00300053

Study Director: | Baxter Healthcare Corporation | One Baxter Parkway, Deerfield, IL 60015 |
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 |
First Posted: | March 8, 2006 Key Record Dates |
Last Update Posted: | September 6, 2010 |
Last Verified: | September 2010 |
Keywords provided by Baxter Healthcare Corporation:
angina |
Additional relevant MeSH terms:
Ischemia Myocardial Ischemia Coronary Artery Disease Pathologic Processes Heart Diseases |
Cardiovascular Diseases Vascular Diseases Coronary Disease Arteriosclerosis Arterial Occlusive Diseases |