Research Reports Clearant Process Sterilization Reduces Infectious Risks in Soft Tissue Allografts

LOS ANGELES -- Clearant, Inc. announces that positive results from a study examining the safety and biomechanical integrity of tissue sterilized with the Clearant Process were published recently in the Journal of Orthopaedic Research (Vol. 24, No. 5). The study concluded that the Clearant Process method of terminal sterilization -- gamma irradiation (50kGy dose) under controlled conditions and following a treatment with radio-protective solution -- can virtually eliminate infections risks associated with soft tissue allografts while maintaining the pre-implantation biomechanical performance of the tissue. According to the company, the Clearant Process is the first method capable of substantially reducing all types of pathogens in tissue implant sterilized in its final packaging, while maintaining the integrity of the essential underlying protein in the tissue.

"Any pathogen inactivation method for allografts should provide the broadest and greatest reduction in infectivity while preserving the biomechanical and biological properties of the tissue. The benefits of sterilization using irradiation are well-known. However, past attempts to sterilize allograft tissues with gamma irradiation have had an adverse effect on tissues' biomechanical properties or the dose of gamma irradiation was not sufficient to sterilize the tissue," commented one of the study's authors, Dr. Jack Lin. "In this study, we've demonstrated that tendon allografts irradiated under the specific conditions of the Clearant Process actually do deliver sterile implants that exhibit favorable biomechanics. The development of such a sterilization method that does not adversely affect tissue function provides added safety to tissues for transplantation."

The investigation examined 28 semitendinosus tendons from donors, ages 15-55 years. The tendons were assigned to a non-irradiated non-sterile control group and the Clearant Process sterile group, and then compared for biomechanical integrity. Pathogen inactivation was also quantified. Additionally, the groups were compared to tendons that had been irradiated to 18 kGy, standard practice at some commercial tissue banks.

Key findings include:

-- No difference was generally detected in the preimplantation biomechanical properties of sterile tendons treated by the Clearant Process when compared to non-sterile, non-irradiated tendons

-- The inactivation of model viruses for HIV, hepatitis C, and West Nile Virus demonstrates that the Clearant Process substantially reduces the risk of viral transmission

-- The bacterial inactivation achieved with the Clearant Process exceeds the FDA minimum requirement for sterility of medical devices

 "This important study provides additional compelling evidence showing that allografts treated with the Clearant Process demonstrate comparable strength and functionality to conventional allografts while significantly reducing the risk of infection. We anticipate that these results will spark a corresponding increase in the adoption of Clearant Process soft tissue implants among surgeons and their patients," said Alain Delongchamp, chief executive officer for Clearant. "The Clearant Process has the potential to bridge the growing divide between supply and patient demand for sterile tissues for transplantation by combining the safety of autograft implants with the convenience of allograft implants."

Source: Clearant, Inc.