Status:
SUSPENDED
Phase II Combination Stem Cell Therapy for the Treatment of Severe Coronary Ischemia(CI)
Lead Sponsor:
TCA Cellular Therapy
Conditions:
Heart Disease
Blocked Arteries
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The present investigation will be a Phase II, single center, placebo-controlled, randomized, dose escalation, infusion modality (intracoronary vs transendocardial injection using the Cordis Biosense N...
Detailed Description
Enrolled individuals (60) will be divided in 2 Treatment groups for the infusion of the cell /placebo product: 1. Treatment Group A (30 individuals, including patients and placebo controls) will rece...
Eligibility Criteria
Inclusion
- Age 18 to 80
- Male or female
- Angina pectoris: Canadian Cardiovascular Society Class III or IV or symptoms consistent with angina equivalent (dyspnea) CCS Class III or IV (Functional Class)
- Chronic coronary artery disease in at least one epicardial vessel with stenosis \> 70% by coronary angiography within the last 6 months
- Stable medical therapy for at least one month
- Reversible perfusion defects by SPECT
- Not a candidate for coronary artery by-pass surgery due to poor targets or small vessels and not a candidate for percutaneous intervention due to small vessels or unreachable coronary lesions due to complicated anatomy
Exclusion
- Inability to give written informed consent
- Previous angiogenic therapy or myocardial laser therapy
- Recent (\< 4 weeks) acute ST-elevation myocardial infarction
- Patients with severe valvular heart disease
- Recent malignancy or radiation therapy (\< 6 months) and not expected to survive 6 months
- Known sensitivity to gentamycin and/or amphotericin B
- Use or expected use of antineoplastic drugs
- Renal insufficiency with creatinine greater than 2.7 unless on dialysis
- WBC greater than 13,000 or lower than 3,000
- Hematocrit lower than 30 or higher than 50
- Platelet counts lower than 60,000 or higher than 500,000
- Child bearing potential without use of contraceptives
- Pregnant or planning to become pregnant
- Any illness which, in the investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient's safety, or interfere with the interpretation of the sturdy results
- Any illness which might affect patient's survival over the study follow-up period
- History of skeletal muscle disease, either primary (i.e. myopathy) or secondary (i.e. ischemic) or any underlying myopathy such as myasthenia gravis, muscular dystrophy, etc
- Patients with active infectious disease and/or who are known to have tested positive for HIV, HTLV, HBV-sAg, HCV, AST or ALT \> 2 times ULRR
- Cardiogenic shock
- Any significant laboratory abnormality which will in the investigator's opinion interfere with the patient's ability to comply with the protocol, compromise the patient's safety, or interfere with the interpretation of the study result
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00790764
Start Date
November 1 2008
End Date
May 1 2014
Last Update
May 9 2014
Active Locations (1)
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1
TCA Cellular Therapy
Covington, Louisiana, United States, 70433