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Abstract: PO0629

Five-Year Outcome in Patients with ESRD Who Received the Bioengineered Human Acellular Vessel for Dialysis Access

Session Information

Category: Development, Stem Cells, and Regenerative Medicine

  • 500 Development, Stem Cells, and Regenerative Medicine

Authors

  • Lawson, Jeffrey, Humacyte, Inc., Durham, North Carolina, United States
  • Niklason, Laura E., Humacyte, Inc., Durham, North Carolina, United States
  • Pilgrim, Alison Jane, Competitive Drug Development SAS, Castillon-du-Gard, France
  • Kirkton, Robert D., Humacyte, Inc., Durham, North Carolina, United States
  • Prichard, Heather L., Humacyte, Inc., Durham, North Carolina, United States
Background

In a previous prospective, phase 2 trial, where 40 Human Acellular Vessels (HAV) were implanted into 40 hemodialysis patients at 3 sites in Poland from 2012 to 2014 (NCT01744418), initial results demonstrated the HAV provided safe and functional hemodialysis access in these subjects at 2 years. This long-term follow-up assessed subject and conduit status in patients who continued routine dialysis with the HAV at 60 months.

Methods

HAVs are bioengineered by culturing human vascular smooth muscle cells (SMC) on a biodegradable polymer matrix within bioreactors that provide pulsatile mechanical strain. After a quantitative decellularization process, the final complete vessel comprises human vascular extracellular matrix constituents and has the mechanical strength of the original vessel without cellular components that might stimulate host immunologic recognition. In this study, subjects with patent HAV implants were followed for subject and functional conduit status every 3 months, starting after the main portion of the study (at Month 27) through at least 5 years post-implantation. This current report contains 5-year follow-up functional and histological data on 29 patients who were previously enrolled in our initial Phase 2 trial.

Results

At Month 60, 1 subject maintained primary patency, two subjects maintained primary-assisted patency, and ten subjects maintained secondary patency. Secondary patency was estimated at 58.2% (95% confidence interval: 39.2 to 73.1%) at 5 years, after censoring for deaths (n=8) and withdrawals (n=1). No infections of HAV conduits reported during follow up period.

Conclusion

This long-term follow up shows that the HAV provides durable and functional hemodialysis access for patients with end-stage renal disease who dialyze three times per week.