Status:
COMPLETED
Safety and Efficacy of Autologous, Intracoronary Stem Cell Injections in Total Coronary Artery Occlusions
Lead Sponsor:
Case Western Reserve University
Collaborating Sponsors:
University Hospitals Cleveland Medical Center
Arteriocyte, Inc.
Conditions:
Coronary Occlusion
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I clinical trial will evaluate the safety and efficacy of intra-coronary injection of AC133 selected autologous marrow-derived stem cells in patients with chronic coronary artery occlusion....
Detailed Description
This study is composed of one phase. The objective of Phase I is to assess the safety and feasibility of performing escalating doses of autologous AC133+ selected bone marrow-derived stem cell with in...
Eligibility Criteria
Inclusion
- The patient must have at least one region of chronically ischemic myocardium formerly perfused by a coronary artery which is now 100% occluded and not revascularizable by conventional percutaneous or surgical methods.
- Well-established collateral vessels at least 1.5-mm luminal diameter by coronary angiography to the chronically ischemic myocardium must be identified at the time of diagnostic coronary angiography.
- Evidence of viable myocardium in the area supplied by collateral conduits intended for stem cell infusion must be demonstrated by nuclear (sestamibi) stress imaging.
- Left ventricular ejection fraction of \>45% as per 2D echocardiogram.
- Patient must experience class II - IV angina as defined by the Canadian Cardiovascular Society (CCS).
- Patient will be followed by the investigating team over the 12 month follow-up period.
- The patient must be at least 18 years of age and have signed an informed consent.
- If the patient is a female of child-bearing potential, a pregnancy test is negative.
Exclusion
- Patients meeting any of the following exclusion criteria will be excluded from the study:
- Patient with coronary lesions amenable to percutaneous coronary intervention including brachytherapy, or where CABG is indicated.
- Any contraindication for cardiac catheterization and percutaneous coronary intervention as per institutional guidelines.
- Any contraindication for bone marrow aspiration as per institutional guidelines.
- Myocardial infarction within the previous 3 months.
- Documented bleeding diathesis.
- Known malignancy involving the hematopoietic/lymphoid system.
- Patients with baseline ECG abnormalities that would hinder interpretation of baseline ECG uninterpretable for ischemia (e.g., left bundle branch block, left ventricular hypertrophy with strain pattern, Wolff-Parkinson-White syndrome).
- Patients with severe co-morbidities including renal failure (serum creatinine \> 2.0).
- Anticipated unavailability for follow-up visits secondary to psychological or social reasons.
- NYHA class III or IV congestive heart failure
- Anemia with hemoglobin concentration \< 8 mg/dl
- Thrombocytopenia with platelet count \< 100 x 103
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00365326
Start Date
January 1 2006
End Date
June 1 2008
Last Update
March 24 2022
Active Locations (1)
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1
Case Western Reserve University
Cleveland, Ohio, United States, 44106