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Honolulu, HI, United States

Agency: Department of Health and Human Services | Branch: | Program: STTR | Phase: Phase I | Award Amount: 98.33K | Year: 2001

DESCRIPTION (Verbatim from Applicant): The objective of this Phase I protocol is to develop a novel approach for the repair of articular cartilage using gene enhanced tissue engineering (GETE). Successful clinical repair of articular cartilage continues to be elusive. The current study seeks to repair articular cartilage defects using constructs containing cultured periosteal cells transduced with IGF-l (insulin-like growth factor) and BMP-7 (bone morphogenic protein) genes as a bilayer implant. As growth factors with strong chondrogenic (IGF-l) and osteogenic (BMP-7) properties, these growth factors have good potential in the healing of osteochondral defects. Tissue constructs have been developed which deliver progenitor cells transduced with IGF-l and BMP-7 genes. Further development of the technology and efficacy will be evaluated in a series of in vivo tests using a lapine knee defect model. These studies will focus on the testing of an improved, safe, and reproducible approach to the repair of joint surfaces. The research design methods to develop the technology are as follows: 1) Construction of a retroviral expression system for delivery of IGF-l and BMP.7 genes. 2) Evaluation of GETE matrices as delivery vehicles for IGF-l and BMP-7 genes. 3) Evaluation of the cartilage reparative capacity using the GETE technology. The parameters for evaluating cartilage repair include: a) Collagen typing as compared to normal cartilage, b) Biochemical measurements of GAG, collagen, and water content within the repaired cartilage tissue, c) Histological characterization of the repaired cartilage, and d) Material properties compared to normal cartilage with respect to modulus and permeability. Further refinements will be the subject of a Phase Il study, which would evaluate this GETE technology in the repair of knee articular cartilage defects in a large animal (sheep) weight bearing joint model. This novel approach using GETE technology should further expand our knowledge of cartilage tissue repair and may have important clinical applications in the future. PROPOSED COMMERCIAL APPLICATION: There is no currently reliable and consistent method used for the repair of articular cartilage. The estimated market for such a device based on approximately 500,000 cases of arthroscopic surgery for damaged cartilage done per year with a price of about $2,000 per implant would mean a market size of 1.05 billion dollars a year for the U.S. market alone.

Agency: Department of Defense | Branch: Army | Program: SBIR | Phase: Phase II | Award Amount: 997.50K | Year: 2015

Tissue Genesis (TGI) is developing a low-cost, highly portable, fully automated adipose-derived stem cell (ADSC) isolation device that addresses current technology limitations including sterility breaks, process time, complexity, and cost. It is an outpatient cell recovery system that prioritizes cell yield, viability, and purity by using novel processes with improved biomaterials. The Phase I SBIR has successfully shown the feasibility of the new technologies being employed in the device, and has defined the path for prototype development. Phase II will take a prototype through iterative design and testing cycles, arriving at a matured product design that will produce high purity ADSCs suitable for all clinical applications. By leveraging ongoing FDA IDE trials and approvals, subsequent efforts will be structured to demonstrate equivalence with the companys industry leading TGI Icellator Cell Isolation System, thereby fast-tracking commercial introduction and use of the new device. In aggregate, this development will produce a commercially viable device that makes access to ADSCs simple, rapid, and cost effective, thereby making therapies using adult stem cells feasible in mainstream medicine for both warfighters and civilians worldwide.

Tissue Genesis, Inc | Date: 2016-07-06

Automated cell extraction systems, namely, electronic apparatus for cell separation for scientific and research use. Automated cell extraction systems, namely, electronic apparatus for cell separation for medical use.

Tissue Genesis, Inc | Date: 2014-09-16

Cell delivery matrices and methods for facilitating local delivery of adipose derived endothelial cells to a target tissue, body cavity, or joint are described. The cell delivery matrix may be a three-dimensional matrix scaffold comprising fibrin derived from the patients own body. The cell delivery matrix may be biocompatible and semi-permeable. The cell delivery matrix used in the methods of the invention may be comprised of any degradable, bioabsorbable or non-degradable, biocompatible polymer. Regenerative therapies comprising implanting in the subject cell delivery matrices localizing adipose derived endothelial cells are described. The cell delivery matrices maintain the adipose derived endothelial cells at the target for a therapeutically effective amount of time. The adipose derived endothelial cells can be allogenic or syngenic to the subject. The endothelial cells may be delivered alone or in combination with other therapeutic agents.

Devices and methods are provided for aspirating adipose tissue with a portable device. This device may include a processing chamber, a cannula, a vacuum source, a filter or screen for separating connective tissue strands from adipose tissue, a digestion area, and a product cell concentration chamber.

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