Novel Manufacturing Processes for Tissue Engineered Vascular Grafts

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 9R44HL118736-04
Agency Tracking Number: R44HL118736
Amount: $2,947,501.00
Phase: Phase II
Program: SBIR
Awards Year: 2013
Solicitation Year: 2013
Solicitation Topic Code: NHLBI
Solicitation Number: HL13-016
Small Business Information
DUNS: 557190449
HUBZone Owned: N
Woman Owned: Y
Socially and Economically Disadvantaged: N
Principal Investigator
 (919) 597-6625
Business Contact
Phone: (919) 313-9633
Research Institution
DESCRIPTION (provided by applicant): This Phase IIB SBIR application is responsive to NHLBI RFA HL-13-016, NHLBI SBIR Phase IIB Bridge Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood and Sleep Disorders and Diseases (R44) . This RFA solicits work on basic, applied, and clinical research on all product and service development related to the mission of the NHLBI... including cardiovascular complications of diabetes and obesity, ... and peripheral vascular diseases. Humaycte has developed a novel vascular graft that has shown excellent function in large animal models. The graft is made by culturing allogeneic human smooth muscle cells in a bioreactor to produce an engineered vascular tissue, which is then carefully decellularized. Vascular dialysis grafts that are 6 mm in diameter function well in a baboon model of arterio-venous grafting. In our Phase II proposal, our aim was the construction and testing of a prototype, disposable vascular graft bioreactor. In this PhaseIIB proposal, we will build on our successful Phase II work, and we will develop a closed, FDA-compliant manufacturing system that can produce manufacturing batches of 100 grafts/unit, enabling production sufficient to support clinical trials and eventualcommercialization. This Phase IIB application will also support a Phase I/II clinical trial examining the safety and efficacy of the engineered vascular graft for hemodialysis access. Manufacturing data from this system, combined with clinical data from our Phase I/II trial, will be submitted to the FDA. At the conclusion of this study, we will file a Special Protocol Assessment (SPA) in support of a Phase III trial in the U.S. on Humacyte's vascular grafts in hemodialysis patients. These grafts have thepotential to decrease morbidity from graft-related complications in patients with end-stage renal disease, as well as other patients requiring arterial bypass grafts. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: This Phase IIB SBIR application addresses a critical need in regenerative medicine: the development of scaled manufacturing systems that produce engineered tissues in a reproducible and economical fashion. This application also tests an engineered vascular graft in end-stage renal disease patients requiring hemodialysis access.

* Information listed above is at the time of submission. *

Agency Micro-sites

SBA logo
Department of Agriculture logo
Department of Commerce logo
Department of Defense logo
Department of Education logo
Department of Energy logo
Department of Health and Human Services logo
Department of Homeland Security logo
Department of Transportation logo
Environmental Protection Agency logo
National Aeronautics and Space Administration logo
National Science Foundation logo
US Flag An Official Website of the United States Government