Morrisville, NC, United States
Morrisville, NC, United States

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Patent
Humacyte | Date: 2012-05-21

The present invention provides compositions comprising isolated human collagen, isolated human elastin and a pharmaceutically acceptable carrier wherein the human elastin is substantially insoluble in water with a molecular weight greater than 100 kDa. The present invention further provides methods and kits for soft tissue augmentation.


Patent
Humacyte | Date: 2014-09-24

The present invention provides constructs including a tubular biodegradable polyglycolic acid scaffold, wherein the scaffold may be coated with extracellular matrix proteins and substantially acellular. The constructs can be utilized as an arteriovenous graft, a coronary graft, a peripheral artery bypass conduit, or a urinary conduit. The present invention also provides methods of producing such constructs.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 2.95M | Year: 2013

DESCRIPTION provided by applicant This Phase IIB SBIR application is responsive to NHLBI RFA HL andquot NHLBI SBIR Phase IIB Bridge Awards to Accelerate the Commercialization of Technologies for Heart Lung Blood and Sleep Disorders and Diseases R andquot This RFA solicits work on andquot 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 andquot 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 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 Phase IIB 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 grafts unit enabling production sufficient to support clinical trials and eventual commercialization 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 Humacyteandapos s vascular grafts in hemodialysis patients These grafts have the potential 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 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


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 217.28K | Year: 2014

The overall goal of this Phase I SBIR application is to develop a non-cell-based means of inhibiting coagulation and platelet activation on engineered vascular grafts, so that small-diameter arterial grafts may be available off the shelf. This arterial graft will consist of human engineered tissue that is decellularized and coated with a novel, covalently-bound layer that mimics aspects of the endothelial cell glycocalyx. By providing an anti-thrombotic function through inhibition of the intrinsic clotting pathway and platelets, this coating will address the main problem with current small diameter vascular grafts, which is early, severe clotting. If functional and successful, this engineered, coated arterial graft will provide an option for patients who lack available vein for bypass conduit, and possibly eliminate the need to harvest a patient's own vein tissue for use as a replacement conduit in vascular bypass surgeries. Cardiovascular disease is the most costly and deadly disease in the US and in mu


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 1.19M | Year: 2011

DESCRIPTION (provided by applicant): This Phase II SBIR application is responsive to Program Announcement PA-09- 113, Manufacturing Processes of Medical, Dental and Biological Technologies . This PA solicits work on technology for the manufacture of implantable devices and materials, prosthetic organs, and artificial tissues . Humacyte 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. This engineered tissue is then carefully decellularized, so as to remove the immunogenic cellular components, while retaining the collagenous extracellular matrix. These grafts have the advantage of being non-living, and hence can be stored on the shelf for periods of up to 9 months. Vascular dialysis grafts that are 6 mm in diameter function well in a baboon model of arterio-venous grafting, and are resistant to two important failure modes of synthetic dialysis grafts: thrombosis and intimal hyperplasia. This SBIR application is directed at scaling the manufacture of this exciting and novel engineered tissue. In our Phase I proposal, our aim was the construction and testing of a prototype, disposable vasculargraft bioreactor. In this Phase II proposal, we will build on our successful Phase I work, and we will refine and build a scaled-up manufacturing system that will enable cost-effective production of our unique, off-the-shelf vascular graft for dialysis access. This pilot scaled system will also be applicable to the manufacture of other types of engineered tissues, and hence will benefit the regenerative medicine field as a whole. We will hone the single-use bioreactor system and in parallel, we will definerapidly consumed components of culture medium and develop a strategy to supplement those limiting factors, thereby reducing overall culture medium usage. Together, these strategies will allow us to produce a scaled, economical manufacturing system. Dialysis grafts produced in the scaled system will be assessed using standard assays for graft biochemical extracellular matrix composition, cell viability, mechanical integrity, as well as graft in vivo function in a primate model. The results of these studieswill contribute to the submission of an IND application to the FDA. PUBLIC HEALTH RELEVANCE: This Phase II SBIR application addresses a critical need in regenerative medicine: the development of scaled manufacturing systems that produce engineeredtissues in a reproducible and economical fashion.


Patent
Humacyte | Date: 2016-04-27

The present invention provides constructs including a tubular non-woven biodegradable polyglycolic acid scaffold. The constructs can be utilised as an arteriovenous graft, a coronary graft, a peripheral artery bypass conduit, or a urinary conduit. The present invention also provides methods of producing such constructs.


Patent
Humacyte | Date: 2014-08-18

The present invention provides compositions comprising isolated human collagen, isolated human elastin and a pharmaceutically acceptable carrier wherein the human elastin is substantially insoluble in water with a molecular weight greater than 100 kDa. The present invention further provides methods and kits for soft tissue augmentation.


Patent
Humacyte | Date: 2012-01-06

The present invention provides constructs including a tubular biodegradable polyglycolic acid scaffold, wherein the scaffold may be coated with extracellular matrix proteins and substantially acellular. The constructs can be utilized as an arteriovenous graft, a coronary graft, a peripheral artery bypass conduit, or a urinary conduit. The present invention also provides methods of producing such constructs.


Patent
Humacyte | Date: 2014-09-24

The present invention provides constructs including a tubular biodegradable polyglycolic acid scaffold, wherein the scaffold may be coated with extracellular matrix proteins and substantially acellular. The constructs can be utilized as an arteriovenous graft, a coronary graft, a peripheral artery bypass conduit, or a urinary conduit. The present invention also provides methods of producing such constructs.


Adipose tissue has proven to serve as an abundant, accessible, and rich source of endothelial or vascular endothelial cells suitable for tissue engineering. We describe a detailed method for the isolation and purification of endothelial cells using purified enzymes and antibody-based selection. The cells can be obtained from liposuction procedures and used in vascular grafts.

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