Publications

Transendocardial Autologous Bone Marrow Cells in Chronic Myocardial Infarction Using Helical Needle Catheter, Six Month Follow-up in an Open-Label, Non-Randomized, Single-Center Pilot Study of an Adult Stem Cell Stimulation Program (the TABMMI Study)

Luis De La Fuente, et. al., The Stem Cell Meeting, March 2007, San Francisco, CA

Cell therapy has shown benefit in preclinical and clinical studies, although debate continues on the mechanism of action and the most appropriate methods for performing such therapies.  We assessed the hypothesis that helical needle transendocardial (TE) delivery of ABM around regions of dyskinesia in chronic post-MI patients would be safe and possibly improve ejection fraction, as this system presents theoretical advantages over other TE delivery systems and was applied to promote a specific mechanism of action.  Methods: Stable post-MI Patients (N=10) with an ejection fraction (EF) <40% were enrolled.  ABM cells were aspirated from the iliac crest and delivered percutaneously with a TE helical needle catheter. 86 x 106 cells were injected into 7.1+/-3.1 sites around the infarct to target the peri-infarct zones. 2D echo LV EF measurements, 24 hour Holter, and exercise tolerance testing were performed at baseline, day of procedure, and at 1W, 3M, and 6M after procedure. Results: Of the cells prepared for delivery 98% were viable, 2.2% were CD34+, and 0.03% were CD133/1+. There were no adverse events associated with the catheter based cell transplantation procedure. One hour after the procedure, there was a statistically significant rise in Troponin I and CK MB. At most recent follow-up of 6 months, there were statistically significant increases in LV EF on echo (35.4 +/- 4.1 to 40.8+/-4.5, p=0.003, N=10); with no acute events or sustained arrhythmias. Twelve month data on these patients has been submitted for peer review publication.   Conclusion: ABM cells delivered transendocardially with the helical needle in this pilot study improved ventricular wall motion in chronic MI patients without arrhythmias, or other clinical complications.  Based on this safety profile an application to initiate a larger double blind trial in the United States is planned for submission to the FDA in 2007.