SBIR-STTR Award

Neocartilage Chondral Allograft Development
Profile last edited on: 6/17/2008

Program
SBIR
Agency
NIH | NIAMS
Total Award Amount
$839,955
Award Phase
2
Principal Investigator
Joseph Feder
Activity Indicator

Company Information

ISTO Biologics Inc (AKA:ISTO Technologies, Inc)

1155 Olivette Executive Parkway Suite 200
St Louis, MO 63132
   (314) 995-6049
   info@istotech.com
   www.istotech.com
Multiple Locations:   
Congressional District:   01
County:   St. Louis

Phase I

Phase I year
1999
Phase I Amount
$90,000
Chondrocytes derived from human donor cartilage can be grown in vitro and under appropriate serum-free conditions form a biomechanically stable cartilage-like tissue (neocartilage) exhibiting biochemical and morphological properties similar to those of the native tissue. Allografts of such rabbit neocartilage have been implanted in surgically created articular defects in rabbits with impressive integration with the surrounding cartilage tissue. These studies support potential use of neocartilage as an allograft material for surgical repair of chondral and osteochondral lesions. To facilitate the use of the neocartilage for surgical repair it is necessary to optimize the growth and maturation conditions of the chondrocyte cultures, correlating endpoints of matrix production with measurable mechanical properties. The expansion potential of prepubescent chondrocytes, which still retain the potential for matrix production, will be determined. The effect of maturation, time in culture during neocartilage formation, on the biochemical composition and morphology of the neocartilage will be studied and correlated with several cartilage parameters of tissue composition and biomechanical properties. The goal of this project is to optimize the process for the production of functional cartilage allografts.

Thesaurus Terms:
biomechanics, cartilage development, chondrocyte, tissue /cell culture, tissue engineering cell age, growth media, tissue support frame human tissue, medical implant science

Phase II

Phase II year
2002 (last award $$: 2003)
Phase II Amount
$749,955
Because chondrocytes in culture are phenotypically unstable, techniques to grow tissue-engineered cartilage for the repair of injured or arthritic joints have met with limited success. Using human donor chondroctyes, we have developed an innovative method for producing what we call neocartilage, a viable, biomechanically stable tissue that we plan to commercialize for the repair of chondral defects in knee joints. Unlike native adult cartilage, which has no capacity for continued growth or repair, the chondrocytes in our neocartilage continue to produce cartilage molecules, resulting in a cartilage tissue that has the potential to repair chondral defects resulting from trauma. In this proposal , we will optimize tissue culture techniques needed for neocartilage production. As a preface to the transplantation studies, we will optimize methods for fixation of neocartilage allografts to the host tissue. In addition, we will evaluate the structural, biochemical, and biomechanical properties of the neocartilage allografts both pre- and post- transplanation in a weight-bearing sheep model. This proposal is unique because it combines biomechanical and biochemical methods of evaluating integrative repair of cartilage defects. We anticipate that upon completion of this proposal, the necessary data will be available to design a pre-clinical study for presentation to the FDA. PROPOSED COMMERCIAL APPLICATION: Our IstoCyte neocartilage has the potential to repair damaged chondral lesions in injured joints perhaps preventing these lesions from destroying bone and cartilage. Furthermore, the neocartilage allograft can offer arthritis patients an alternative to current therapies, perhaps preventing osteoarthritis or delaying total joint replacement.

Thesaurus Terms:
biomaterial development /preparation, biomechanics, cartilage development, chondrocyte, homologous transplantation, immunoregulation, tissue /cell culture, tissue engineering bone morphogenetic protein, cell proliferation, extracellular matrix, histocompatibility antigen, interleukin 4, knee, tensile strength, tissue support frame, transforming growth factor colorimetry, confocal scanning microscopy, gamma radiation, histochemistry /cytochemistry, immunofluorescence technique, medical implant science, nucleic acid purification, sheep