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Novel Manufacturing Processes for Tissue Engineered Vascular Grafts

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
Program Year/Program:
2013 / SBIR
Agency Tracking Number:
R44HL118736
Solicitation Year:
2013
Solicitation Topic Code:
NHLBI
Solicitation Number:
HL13-016
Small Business Information
HUMACYTE, INC.
PO BOX 12695 RESEARCH TRIANGLE PARK, NC 27709-
View profile »
Woman-Owned: Yes
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2013
Title: Novel Manufacturing Processes for Tissue Engineered Vascular Grafts
Agency: HHS
Contract: 9R44HL118736-04
Award Amount: $2,947,501.00
 

Abstract:

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.

Principal Investigator:

Shannon L. Dahl
919-597-6625
dahl@humacyte.com

Business Contact:

Shannon L. Dahl
919-313-9633
dahl@humacyte.com
Small Business Information at Submission:

HUMACYTE, INC.
PO BOX 12695 RESEARCH TRIANGLE PARK, NC 27709-

EIN/Tax ID: 184166129
DUNS: N/A
Number of Employees: N/A
Woman-Owned: Yes
Minority-Owned: No
HUBZone-Owned: No