Terminal Sterilization of Tendon Allografts Using Supercritical CO2- Phase II

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Department of Health and Human Services
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Phase II
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(607) 330-2772
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DESCRIPTION (provided by applicant): Currently, most tissue banks use a two step process to sterilize soft tissue allografts. The initial step reduces the bioburden with the second step in sterilization resulting in terminal sterilization . The direct res ult of Phase 1 funding has been the development of a terminal sterilization technology using supercritical CO2 and a proprietary additive that will allow tissue banks to easily process soft tissue allografts to a sterility assurance level equal to that cal led for in medical devices (SAL6) in a one step process. Sterilization was confirmed according to the standards in AMI/ISO 11737-1 and 2. The sterilization technology is capable of inactivating a wide variety of microorganisms at concentrations of greater than 106 colony forming units (CFUs) in a half cycle. Utilizing sterilization times as determined from D-value calculations according to the methods of Stumbo-Murphy-Cochran (terminal sterilization at 2.5 hours and overkill at 4 hours) we assessed the affe ct of our supercritical CO2 process on the biomechanical properties of bone-tendon-bone (BTB) patellar tendon allografts. Biomechanical data obtained revealed no significant difference between the supercritical CO2 sterilized and control group (ANOVA stati stical analysis and paired T-testing). The technology developed in Phase 1 will offer an alternative to methods of sterilization of soft tissue allografts used by tissue banks. Musculoskeletal conditions (diseases and disorders) have a tremendous impact on society. In the United States alone, musculoskeletal conditions cost society an estimated 254 billion yearly with 1 out of every 7 Americans reporting a musculoskeletal impairment. Each year, 28.6 million Americans incur a musculoskeletal injury with app roximately 7.5 million musculoskeletal procedures performed by physicians. The importance of allograft tissue in the treatment of orthopedic patients has grown rapidly during the last decade. Tendon, ligament and joint injuries represent 45% of the musculo skeletal injuries each year. Tendon injuries are especially common, requiring surgical repair to replace shoulder rotator cuff tendons (51,000/year), achilles tendon (44,000/year), and the patellar tendon (42,000/year) to name a few. Concomitant with the i ncreased demand for tissue has been the increase potential of exposures to pathogens. There is high potential for bacterial or viral contamination of allograft tissue without adequate secondary sterilization processing. Thus, the safety of allograft tissue has become a primary focus for the tissue bank industry, clinicians, and the FDA. Phase II funding will allow us to further optimize the sterilization process by addressing packaging (double packaging and header packs) as recommended by tissue banks and o rthopedic surgeons. This packaging will result in a terminally sterilized product ready for direct transfer for transplant. The importance of allograft material in the treatment of orthopedic patients has grown rapidly during the last decade, which lea ds to a growing concern for an increased potential of exposure to pathogens. Viral and bacterial contamination of allograft tissue without adequate secondary sterilization processing remains an issue. Thus, the safety of allograft tissue has become a prima ry focus for the tissue bank industry, clinicians and the FDA. The tissue bank industry and processing centers have invested numerous hours and a large amount of money into methods of processing to achieve a high quality and safe. By providing a one step t erminal sterilization process (sterilized grafts in final packaging), our company would be adding value and safety to the processing that occurs in the tissue bank industry. The only two processes capable of terminal sterilization of allografts are ethylen e oxide and gamma irradiation which suffer from major drawbacks if used at a concentration to achieve SAL6 thus requiring a two step process to minimize the

* information listed above is at the time of submission.

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