Intramyocardial Delivery of Autologous Bone Marrow

U.S. FDA Resources

Enrollment:	13
Study Start Date:	May 2007
Estimated Study Completion Date:	December 2018
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Detailed Description:

Inclusion criteria:

1. Subjects >21 years old;
2. Subjects with functional class (CCS) III or IV angina;
3. Subjects with left ventricular (LV) ejection fraction ³ 30%
4. Attempted "best" tolerated medical therapy
5. Clinical signs and symptoms of myocardial ischemia with reversible ischemia on perfusion imaging;
6. Patient deemed to be a poor candidate or at high surgical risk;
7. Subject must be able to complete a minimum of 2 minutes but no more than 10 minutes exercise test (Bruce Protocol);
8. Subject (or their legal guardian) understands the nature of the procedure and provides written consent prior to the procedure;
9. Subject is willing to comply with specified follow-up evaluations;
10. Patient must develop angina and a horizontal or down-sloping ST-segment depression of ³ 1 mm during exercise, compared to pre-exercise ST segment, 80 ms from the J point or moderate angina with or without the above ST segment changes.

Angiographic Inclusion Criteria:

1. Severe obstruction (lumen diameter stenosis > 70%) in a coronary or surgical conduit felt to be solely or partially responsible for angina and myocardial ischemia;
2. There must be at least one coronary or surgical conduit with < 70% diameter stenosis
3. Poor candidate for percutaneous coronary intervention of treatment zone
4. Poor candidates for surgical revascularization procedures, such as inadequate target coronary anatomy or lack of potential surgical conduits.

Exclusion Criteria:

1. Pregnant women;
2. Left ventricular ejection fraction <30% as assessed by either echocardiography or left ventriculography;
3. Severe cardiac heart failure with NYHA functional class III-IV symptoms;
4. Chronic atrial fibrillation;
5. Prosthetic aortic valve;
6. Severe (grade III-IV) mitral or aortic insufficiency;
7. Wall thickness of <8 mm (defined by echocardiography) of the proposed target region of myocardium;
8. Severe co-morbidity associated with a reduction in life expectancy of <1 year, such as chronic medical illnesses
9. Braunwald class II unstable angina
10. Severe peripheral (or aortic) vascular disease which might increase the risk of vascular complications (perforation, dissection or embolization);
11. Significant aortic valve pathologic sclerosis or stenosis
12. LV thrombus (mobile or mural-based) seen on echocardiography;
13. Recent (within 4 weeks) documented myocardial infarction (Q and/or non-Q wave) defined as CK-MB >3times upper normal level;
14. Currently enrolled in another investigational device or drug trial that has not completed the required follow-up period;
15. Thrombocytopenia or history of heparin-induced thrombocytopenia or thrombocytosis
16. Leukopenia
17. Leukocytosis
18. Anemia or erythrocytosis
19. Active peptic ulcer or active gastrointestinal bleeding;
20. Chronic renal failure requiring dialysis;
21. Prior or current malignancy
22. Other conditions that can significantly affect the bone-marrow
23. Evidence of concurrent infection (WBC >12.000 mm3, temperature >38.5° C);
24. Serological of clinical evidence of HIV
25. Immunotherapy
26. Abnormal bone-marrow morphology as evident in bone-marrow smear prior to the intervention

Angiographic/Ventriculographic Exclusion Criteria:

1. LV thrombus (mobile or mural-based) seen on left ventriculography;
2. Coronary lesions suitable for percutaneous coronary interventions;
3. Unprotected left main coronary artery disease

IRCCS San Raffaele

Intramyocardial Autologous Bone Marrow Randomized

Percutaneous CD34+ Refractory Angina Pectoris.