The genipin-crosslinked fibrin hydrogel (FibGen) is a stiff, biocompatible hydrogel intended to fill tissue defects in load bearing tissue, and this 
particular formulation has the addition of fibronectin or collagen to enhance cell viability, proliferation and phenotypic characteristics. Dr. James Iatridis and his lab formulated the FibGen gel to close and repair the annulus fibrosus (AF) tissue within the intervertebral disc, but it can also be used in other soft tissues such as the meniscus. Defects in AF tissue can lead to internal disc disruption, and cause discogenic back pain in > 3 million people in the US alone.
The use of FibGen as a biocompatible adhesive would be applicable following nucleotomy, discectomy or discography, all surgeries that involve the necessary rupture of AF tissue. This gel can also be used to augment other annulus fibrosus repair strategies. These modified fibrin gels are injectable and cure rapidly in situ and fibrin glues are already used clinically for various applications. The FibGen gel is unique, in that it has been modified with genipin, a plant derived, low toxicity cross-linker and either fibronectin or collagen type I, both cell binding proteins found naturally in AF tissue.
Current Development Status
- In vitro testing showing enhanced AF cell growth and proliferation on gel substrate
- Ex vivo bovine IVD experiments demonstrate excellent adhesion and integration with native tissue
- Small/large animal in vivo testing to commence in Summer 2014
Applications
- Annulus Fibrosus repair for 3.2M US patients with Internal Disc Disruption
Advantages
- Mechanical properties better matched to native AF tissue than fibrin gel alone
- Superior longevity compared with fibrin gel alone (see figure)
- Gel degradation rate is tunable to match tissue specific needs
Publications
- Schek et al. Genipin-crosslinked fibrin hydrogels as a potential adhesive to augment IVD annular repair. Eur Cell Mater. 18, pp.373-83 (2011)
- Iatridis et al. Role of Biomechanics in Intervertebral disc degeneration and Regenerative Therapies: What Needs Repairing in the Disc and What are Promising Biomaterials for its Repair. Spine J. 13,pp.243-62 (2013)
- Guterl et al. Characterization of Mechanics and Cytocompatibility of Fibrin-Genipin Annulus Fibrosus Sealant with the Addition of Cell Adhesion Molecules. Tissue Eng Part A. April (2014), ahead of print
Patent Status
- US CIP Application 13/907,442 filed May 31, 2013
- Status: Pending. US Publication No. US-2013-0345321 A1
- US Divisional Application 14/483,284 filed September 11, 2014
- Status: Published. US Publication No. 2015-0004138 A1
Contact
Christopher Frenz, PhD
Business Development Analyst
Mount Sinai Innovation Partners | Icahn School of Medicine at Mount Sinai
Phone: 646.605.7316