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Clinical Study Demonstrates That CLEARANT PROCESS(R) Improves ACL Reconstructive Surgery Results; Study of 70 Patients Shows 0% Rate of Infection

Posted on: Tuesday, 26 July 2005, 09:01 CDT

Clearant, Inc., (OTCBB:CLRI) the developer of the CLEARANT PROCESS(R) for pathogen inactivation, announced today results from a one-year clinical evaluation of 70 patients undergoing anterior cruciate ligament (ACL) reconstructive surgery using the CLEARANT PROCESS(R), a terminal sterilization technology that virtually eliminates the pathogens that can cause post-operative surgical site infections. The study of 70 patients showed that there was a 0% infection rate, far superior to those patients observed with currently available, non-sterile implants. The results, consistent with the data from more than 4,000 patients implanted with soft tissue allografts using the CLEARANT PROCESS sterilization technology, were reported at the Annual Meeting of the American Orthopaedic Society for Sports Medicine.

Of the 70 recipients whose average age was 32 years, 63 patients had excellent outcomes and only 6 had failures (8.6%); these 6 patients were considered to be unusually very active, which could explain the reason for the failures. The results were comparable to the historical average allograft failure rate of 7.3% for non-irradiated, non sterile achilles implants (Siebold, et al, Arch Orthrop Trauma Surg, 2003).

Warren D. King, M.D., a reknowned sports medicine surgeon at the Palo Alto Medical Foundation and the lead study investigator, as well as the team physician for the Oakland Raiders and U.S. Rugby team, said of the results, "In my experience, the CLEARANT PROCESS(R) treated implants had a better outcome than alternative treatments, with no infection or no risk of infection and comparable mechanical performance in patients at one year."

Dr. King concluded that a new method of gamma irradiation, high-dose gamma combined with the CLEARANT PROCESS(R), which achieves a microbial-sterility assurance level of 10-6 (the level of sterility required and provided by medical device suppliers) and significant viral reduction does not compromise the mechanical integrity or clinical performance of allograft tissues.

In addition to the recent clinical study, Clearant previously conducted extensive static and cyclic mechanical integrity testing on over 1,000 allografts treated with the CLEARANT PROCESS(R). Also, a number of independent animal studies were conducted. Each independent animal study demonstrated that the biological activity of the CLEARANT PROCESS(R) treated implants was maintained.

Studies by Clearant have also shown that the dose used by the majority of the industry (low-dose gamma irradiation at 18 Kgys) is not adequate to achieve validated 10-6 sterility (the industry standard for medical devices) in allograft tissue implants for all types of bacteria including resistant bacteria such as clostridium species.

According to the Clinical Infectious Diseases study on allograft infections (July 15, 2005), "patient safety is not assured when allograft tissues have not undergone a sterilization process." In fact, the study states that "the infection rate for aseptically-processed allografts was 4.4%, compared with 0% for patients who received autografts or sterile allografts." Dr King's patients did not experience any infection related to the use of sterile CLEARANT PROCESS treated implants.

Currently, seven tissue processors have licensed the CLEARANT PROCESS(R) for allograft tissue sterilization.

Dr. King's study, published in a paper titled "Microbial Sterilization and Viral Inactivation in Soft Tissue Allografts Using High-Dose Gamma Irradiation: Report of a New Graft Preparation Technique and One-Year Clinical Follow-Up", showed that there was no significant difference in the tensile strength of grafts irradiated to 50 Kgy under controlled conditions using the CLEARANT PROCESS(R) when compared to fresh-frozen allografts. There was also no significant difference in collagen integrity. Robust pathogen inactivation of bacteria, fungi, lipid-enveloped viruses, and non-lipid-enveloped viruses was achieved. One-year follow-up of ACL reconstructions using the CLEARANT PROCESS(R) was comparable to control grafts.

About The American Orthopaedic Society for Sports Medicine The American Orthopaedic Society for Sports Medicine, a world leader in sports medicine education, research, communication, and fellowship, is a national organization of orthopaedic sports medicine specialists, including national and international sports medicine leaders. The Society works closely with many other sports medicine specialists and clinicians, including family physicians, emergency physicians, pediatricians, athletic trainers, and physical therapists to improve the identification, prevention, treatment, and rehabilitation of sports-related injuries.

About Clearant, Inc.

Clearant, Inc., a biotechnology company headquartered in Los Angeles, California, is a leader in pathogen inactivation for biological products. Clearant, Inc. has developed the patent protected CLEARANT PROCESS(R), designed to substantially reduce all types of pathogens in biological products while maintaining a high degree of the underlying protein. Various sterilization methods on the market today only kill specific types of pathogens, such as bacteria or lipid-enveloped viruses, for specific products. The CLEARANT PROCESS(R) can substantially reduce all types of pathogens for products across many market segments including plasma proteins, tissue implants, recombinant products and blood products, and can be applied at various stages of product processing/manufacturing, including in the final container.

Source: Business Wire

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