Status:
COMPLETED
Combination Stem Cell Therapy for the Treatment of Severe Coronary Ischemia
Lead Sponsor:
TCA Cellular Therapy
Conditions:
Coronary Ischemia
Coronary Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
The purpose of this research study is to determine if the infusion of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of new blood vessel...
Eligibility Criteria
Inclusion
- Male or Female age 18-20
- Angina Pectoris: CCS Class II or IV or angina symptom equivalent
- 70% blockage in at least one epicardial vessel documented within 6 months
- Stable medical therapy
- Reversible perfusion defects by SPECT
- Not a candidate for percutaneous intervention or coronary by-pass surgery
Exclusion
- Previous angiogenic therapy or myocardial laser therapy
- Severe valvular heart disease
- Recent malignancy or radiation therapy within 6 months
- Renal insufficiency with creatinine greater that 2.7
- White blood count greater than 13,000 or lower than 3,000
- Platelet count lower than 60,000 or higher that 500,000
- Pregnant or planning to become pregnant
- History of skeletal muscle disease
- AST or ALT greater than two times upper limit of normal
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00643981
Start Date
February 1 2008
End Date
February 1 2009
Last Update
April 28 2011
Active Locations (1)
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1
TCA Cellular Therapy, LLC
Covington, Louisiana, United States, 70433