Combination Stem Cell (MESENDO) Therapy for Utilization and Rescue of Infarcted Myocardium

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Myocardial Infarction, Heart Attack, Coronary Artery Bypass Grafting Read More

Inclusion Criteria:

ARM: A -

• Patients with acute myocardial infarction with ST elevation who underwent percutaneous revascularization between 4 and 24 hours after the initiation of symptoms.

  1. Able to give written informed consent
  2. Age: 18 to 70 years
  3. Gender: Male and Female

  4. Acute myocardial infarction occurring within 4-24 hours after onset of symptoms documented by at least one of the following:

     1. ST Segment elevation greater than 2mm in two or more consecutive leads
     2. New Bundle Branch Block with symptoms consistent of MI
     3. Troponin I greater than 2.0 ng/ml (Normal Range 0 - 1.5 ng/ml)
     4. Totally occluded artery as visualized by angiography

ARM - B

Patients who are candidates for coronary artery bypass grafting surgery according to ACC/AHA guidelines and have had a myocardial infarction in the past 12 months.

1. Able to give written informed consent
2. Patients with coronary artery disease who need coronary artery bypass surgery according to ACC/AHA guidelines
3. Patients with Left Ventricular Ejection Fraction £ 40%.
4. NYHA symptoms Class II (dyspnea with moderate effort)
5. Defined region of myocardial dysfunction related to previous myocardial infarction (within the past 12 months) involving the anterior, lateral, posterior or inferior walls by either of the followings: echocardiography, ventriculography, MRI, or SPECT.
6. Age: 18 to 70 years
7. Gender: Male and Female

Exclusion Criteria:

ARM - A

1. Pregnancy
2. Previous angiogenic therapy or myocardial laser therapy
3. History of cancer within 5 years
4. Known sensitivity to gentamycin and/or amphotericin B
5. Use or expected use of antineoplastic drugs
6. No informed consent or unable to provide informed consent.
7. 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 study results.
8. Any illness which might affect patient's survival over the study follow-up period
9. 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.
10. Patients with active infectious disease and/or who are known to have tested positive for HIV, HTLV, HBV-sAg, HCV, CMV and/or syphilis
11. Cardiogenic shock or severe compromise in left ventricular systolic function defined as ejection fraction lower than 20 %.
12. History of intolerance to amiodarone.
13. End stage renal disease
14. Contraindication for MRI
15. 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.
16. Inability to identify the infarct area intra operatively

ARM - B

1. Previous angiogenic therapy or myocardial laser therapy
2. History of cancer within 5 years
3. Cardiogenic shock or severe compromise in left ventricular systolic function defined as ejection fraction lower than 20 %.
4. Left Ventricular Ejection Fraction ≥ 40%.
5. Known sensitivity to gentamycin and/or amphotericin B
6. Use or expected use of antineoplastic drugs
7. No informed consent or unable to provide informed consent
8. Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
9. Any illness which might affect patient's survival over the study follow-up period
10. 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.
11. Patients with active infectious disease and/or who are known to have tested positive for HIV, HTLV, HBV-sAg, HCV, CMV and/or syphilis
12. Poor candidates for coronary artery bypass surgery
13. Patients who are in need of emergency bypass surgery
14. History of prior coronary artery bypass surgery
15. Patients with severe valvular heart disease
16. History of intolerance to amiodarone
17. End stage renal disease
18. Pregnancy
19. Contraindication for MRI
20. 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.
21. Inability to identify infarct area intra operatively.