Author + information
- Peter Johnston1,
- Eric Duckers2,
- Amish Raval3,
- Thomas Cook4,
- Jay Traverse5,
- William Abraham6,
- Peter Altman7 and
- Carl Pepine8
- 1Johns Hopkins University School of Medicine, Baltimore, Maryland, United States
- 2BioCardia, Inc., San Carlos, California, United States
- 3University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, United States
- 4University of Wisconsin, Madison, Wisconsin, United States
- 5Minneapolis Heart Institute Foundation, Minneapolis, Minnesota, United States
- 6Ohio State University, Columbus, Ohio, United States
- 7BioCardia, San Carlos, California, United States
- 8University of Florida, Gainsville, Florida, United States
Stem cell therapy shows promise in experimental ischemic cardiomyopathy (ICM), although results in clinical trials are variable. Growing data suggests that marked differences in stem cell regenerative potential contribute to differential effects. The CardiAMP Heart Failure Trial (CardiAMP-HF) is the first to prospectively assess stem cell therapeutic potency as part of enrollment criteria. Here we report first results from the CardiAMP-HF Roll-In Phase.
Patients with chronic ICM, ejection fraction 20-40%, on optimal medical therapy with NYHA Class 2-3 heart failure symptoms were screened; all underwent screening bone marrow aspiration (BMA). Ten patients who met criteria were enrolled in the unblinded "Roll-In" phase and received intramyocardial injection of high dose (target 2x108) autologous bone marrow mononuclear cells (BM-MNCs). Briefly, after repeat BMA, BM-MNCs were isolated with the point-of-care CardiAMP Cell Separator. Intramyocardial delivery of BM-MNCs at the infarct border was performed using the BioCardia Helical Injection catheter. To date Roll-In participants have been followed for 9 months with a primary outcome of 6-minute walk distance (6MWD) and secondary outcomes including NYHA Class and MLWHFQ score.
All patients had successful BMA, BM-MNC isolation, and delivery with no peri-procedural SAE. At 9 months there was significant improvement in 6-MWD: +72.7m+76.8, a 21.3% improvement relative to baseline (p=0.022). Similar results were seen for change in NHYA Class at 6 months: 4/10 with 1 or 2 class improvement (p=0.037) and borderline at 9 months: 4/9 (p=0.051). A trend for improvement in MLWHFQ score was also seen at 9 months: -8.6+18.4, a 26% relative change (p=0.20). Twelve month follow-up results and additional data will be available by the time of presentation.
CardiAMP-HF is the first multicenter clinical cell therapy trial to prospectively screen for stem cell therapeutic potency. Early results from the unblinded "Roll-In" phase of the study suggest improvement in 6MWD and NYHA class and support continued investigation in the 250 patient randomized double-blind sham-controlled phase of CardiAMP-HF, which is actively enrolling.
OTHER: Cell Therapy and Angiogenesis