Surgeons world-wide currently perform more than 240,000 corneal transplants a year to address a wide range of eye diseases. Researchers and physicians, however, estimate as many as 10 million patients could benefit from the procedure if enough viable tissue was available.
The University of Missouri-Kansas City Vision Research Center is part of a $1.5-million National Institutes of Health grant-funded project exploring the capability of a novel, ultra-fast technique of cryopreservation that could help meet those far-reaching clinical needs in ophthalmology and a number of other fields of medicine.
The NIH awarded a phase II Small Business Innovation Research (SBIR) grant to CryoCrate, a Columbia, Missouri-based company active in biomedicine working with the University of Missouri-Kansas City Vision Research Center. The new two-year award is for $1,566,168 and includes a subcontract of $722,870 to UMKC’s Vision Research Center. It is a follow-up grant to previous phase I SBIR funding from the NIH for earlier collaborative work between CyroCrate and UMKC.
With current techniques, many types of cells and tissues, including cornea tissues, cannot be preserved at all or lose their function when subjected to the freeze-thaw process of cryopreservation. Peter Koulen, Ph.D., professor of ophthalmology, endowed chair in vision research at the UMKC School of Medicine and director of basic research at the UMKC Vision Research Center, and Xu Han, Ph.D., president and Chief Technology Officer of CryoCrate, jointly developed a new cryopreservation technique to preserve the viability and functionality of cornea and bioartificial ocular tissues. The new phase II SBIR funding will allow Han and Koulen to extensively test and refine the technology before taking it to the clinics.
Thus far, traditional methods of cryopreservation have been unsuccessful to preserve and store human corneas for use in patients due to the fact that cells critical for cornea function are lost during freezing. Corneas need adequate numbers of such cells to be present and properly functioning in the grafted tissue for the surgery to be successful. This currently limits storage of corneas to refrigeration, which is insufficient in delaying the deterioration of cornea tissue beyond a few days and creates numerous clinical challenges shared by other areas of transplantation.
CryoCrate is headquartered at the Missouri Innovation Center. It commercializes a new cooling method that better preserves tissue in a frozen state with only negligible mechanical damage to the tissue. The technology is co-developed and co-owned by CryoCrate and UMKC. It also eliminates the need for so called cryoprotectants, chemicals that facilitate successful recovery of live tissue from freezing, but pose a range of medical and regulatory challenges. International patents pending and patents by CryoCrate and UMKC protect the technology and will enable CryoCrate and Koulen’s team at UMKC to address the urgent worldwide clinical needs and rapidly evolving fields of transplantation medicine.
The new NIH SBIR phase II grant allows Han and Koulen to further develop an upgraded system that is equally effective in the cryopreservation of whole corneas and large bioartificial tissue. This would enable long-term storage of the tissues and could make them more readily available when and where needed for clinical use and research.
Early tests at the UMKC Vision Research Center detected no statistical difference in the number and quality of the cells that determine cornea health and function, when comparing corneas cryopreserved using the new technology with fresh cornea tissue. This level of efficiency in preserving corneal tissue has not been achieved previously with traditional corneal cryopreservation techniques.
If further tests prove to be equally effective, the goal is to introduce the new cryopreservation products for clinical use in patients following completion of the new NIH SBIR phase II grant and subsequent regulatory steps of product development.