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Abstract: TH-PO755

Immunomodulation Therapy Improves Cardiac Function in Chronic Heart Failure (CHF)

Session Information

  • Bioengineering
    October 25, 2018 | Location: Exhibit Hall, San Diego Convention Center
    Abstract Time: 10:00 AM - 12:00 PM

Category: Bioengineering

  • 300 Bioengineering

Authors

  • Buffington, D., Innovative BioTherapies, Inc., Ann Arbor, Michigan, United States
  • Westover, A., Innovative BioTherapies, Inc., Ann Arbor, Michigan, United States
  • Lou, L., Innovative BioTherapies, Inc., Ann Arbor, Michigan, United States
  • Pino, C., Innovative BioTherapies, Inc., Ann Arbor, Michigan, United States
  • Johnston, K., Innovative BioTherapies, Inc., Ann Arbor, Michigan, United States
  • Sabbah, Hani N., Henry Ford Health System, Detroit, Michigan, United States
  • Humes, H. David, Innovative BioTherapies, Inc., Ann Arbor, Michigan, United States
Background

Cardiovascular disease is the leading cause of mortality in the US, accounting for 45% of all deaths. CHF and cardiorenal syndrome (CRS) are now understood to be multi-system disease processes involving not only the cardiovascular system but also the renal, neuroendocrine and immune systems. No effective therapy is currently available to treat the most severe subset of CHF patients that have progressed to acute decompensated HF. The Selective Cytopheric Device (SCD) is an immuno-regulating, extracorporeal, membrane device targeted to modulate the cardio-depressant effects that are associated with CHF. SCD is a platform technology focused on immunomodulation of the acute and chronic inflammation associated with acute and chronic organ dysfunction. SCD polysulfone fibers selectively sequester and immunomodulate activated systemic leukocytes as they flow through the fiber casing via an extracorporeal circuit and are subsequently released back to the systemic circulation.

Methods

12 dogs with advanced CHF (ejection fraction (EF) <35%) were used: 5 dogs received sham therapy (No Rx) and 7 dogs received SCD Rx sessions. 6-hour Rx sessions were administered every 48-72 hours for a total of 3 times over a 1-week period. Cardiac parameters were measured at 48 hours, 2 and 4-weeks post. Samples were taken to evaluate of systemic cytokines, leukocyte immune state, spleen density, and macrophage distribution in heart tissue and peritoneal lavage.

Results

EF% significantly increased in SCD Rx animals from 34.0±0.8 to 38.7±1.2% (p<0.01) measured at 48 hours post Rx and sustained through 4 weeks at 39.3±1.5% (p<0.005). EF% correlated with significant increases in stroke volume, end systolic volume and overall cardiac output. Changes were not observed in control animals. Changes in cardiac parameters correlated to a decrease in systemic leukocyte activation as measured by CD11b, decrease in macrophage density in heart, less pro-inflammatory macrophages in peritoneal lavage, and normalization of spleen cell density.

Conclusion

Pre-clinical study results show SCD Rx for CHF to have clinically relevant therapeutic benefit that was sustained over the 4-week follow-up period. A pilot clinical study is planned to evaluate this approach in severe CRS.

Funding

  • Other NIH Support