Stem Cell Study for Patients With Heart Disease
Injection of Autologous CD34-Positive Cells for Neovascularization and Symptom Relief in Patients With Myocardial Ischemia
1 other identifier
interventional
24
1 country
3
Brief Summary
The purpose of this study is to determine if cell therapy with your own cells (autologous cells) delivered with a catheter to regions of the heart with poor blood flow will be safe and if it will relieve your chest pain and/or your ability to exercise.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2004
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 26, 2004
CompletedFirst Posted
Study publicly available on registry
April 28, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedJanuary 29, 2008
January 1, 2008
2.2 years
April 26, 2004
January 23, 2008
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Subjects with functional class (CCS) III or IV angina.
- Subjects who have attempted "best" medical therapy without control of symptoms.
- All subjects must have a recent coronary angiogram (within the last 3 months).
- Clinical signs and symptoms of clinically significant ischemia on nuclear perfusion imaging.
- Subjects must be able to complete a minimum of 1 minute but no more than 6 minutes of the Standard Bruce Protocol.
- Subject experiences angina during the baseline exercise tolerance test.
- Subjects must either be no longer capable of reproduction or taking acceptable measures to prevent reproduction during the study.
- Normal renal function.
- Normal liver function.
- Normal blood count.
- Total occlusion of an epicardial coronary artery.
- Candidates at high risk for percutaneous coronary angioplasty of treatment zone(s) based upon clinical or anatomic considerations including but not limited to the following: diabetes, congestive heart failure (severe right heart failure, NYHA class III or IV), left main disease, pulmonary hypertension, severe proximal vessel tortuosity, severe bendpoint obstructions, diffuse disease (\>2 cm in length), small vessel (\<2 mm reference diameter), stenosis which are either diffuse (\>2 cm in length) or distal, incessant restenosis lesions, unfavorable bifurcation stenosis, and degenerated or thrombosed saphenous vein grafts.
You may not qualify if:
- Predominant congestive heart failure symptoms.
- Patients who have been hospitalized with a primary diagnosis of CHF in the prior 6 months.
- Patients who have had diuretics added to their medical regimen or an increase in diuretic dosage for signs or symptoms of CHF in the past 6 months.
- Patients with a left ventricular ejection fraction of less than 25% as determined by transthoracic echocardiography.
- Patients with physical findings consistent with ongoing uncontrolled CHF.
- Myocardial infarction within 30 days of treatment.
- Successful coronary revascularization procedures within 3 months of study enrollment.
- Documented stroke or transient ischemic attack (TIA) within 60 days of study enrollment.
- History of severe aortic stenosis or insufficiency; severe mitral stenosis; or severe mitral insufficiency.
- Severe co-morbidity associated with a reduction in life expectancy of less than 1 year.
- Subjects with PT, PTT or platelet counts greater than the upper limit of normal and those with a hematocrit \<35%.
- Subjects with uncontrolled hypertension.
- Currently enrolled in another investigational device or drug trial (IDE or IND) that has not completed the required follow-up period.
- History of alcohol or drug abuse within 3 months of screening.
- Joint or peripheral vascular disease that severely limits treadmill walking.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Scripps Clinic
La Jolla, California, 92037, United States
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, 02135, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
Related Publications (1)
Losordo DW, Schatz RA, White CJ, Udelson JE, Veereshwarayya V, Durgin M, Poh KK, Weinstein R, Kearney M, Chaudhry M, Burg A, Eaton L, Heyd L, Thorne T, Shturman L, Hoffmeister P, Story K, Zak V, Dowling D, Traverse JH, Olson RE, Flanagan J, Sodano D, Murayama T, Kawamoto A, Kusano KF, Wollins J, Welt F, Shah P, Soukas P, Asahara T, Henry TD. Intramyocardial transplantation of autologous CD34+ stem cells for intractable angina: a phase I/IIa double-blind, randomized controlled trial. Circulation. 2007 Jun 26;115(25):3165-72. doi: 10.1161/CIRCULATIONAHA.106.687376. Epub 2007 Jun 11.
PMID: 17562958DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDIV
Study Record Dates
First Submitted
April 26, 2004
First Posted
April 28, 2004
Study Start
January 1, 2004
Primary Completion
March 1, 2006
Study Completion
June 1, 2006
Last Updated
January 29, 2008
Record last verified: 2008-01