• Aastrom Biosciences (Ann Arbor, Michigan) reported that it has expanded the U.S. Phase I/II clinical trial of its adult stem cell-based Tissue Repair Cells (TRCs) in the treatment of severe long bone non-union fractures to include the department of orthopedic surgery at William Beaumont Hospital (Royal Oak, Michigan). This is the third site now engaged in the U.S. multi-center trial, which is currently underway. Accrual of patients into the study is expected to begin immediately.

• BD (Becton, Dickinson and Co.; Franklin Lakes, New Jersey), through its BD Diagnostics business, reported that the FDA has cleared the BBL CHROMagar MRSA product. The new prepared plated medium simplifies the process, decreases the time to result and offers high sensitivity and specificity for methicillin-resistant Staphylococcus aureus (MRSA) identification. BBL CHROMagar MRSA allows microbiology laboratories to identify patients colonized with MRSA more quickly and easily than the processes currently available, within 24 hours. BBL CHROMagar MRSA uses a new chromogenic technology that permits the detection of MRSA using chromogenic substrates and a cephalosporin. MRSA strains will grow in the presence of antibiotics and produce mauve-colored colonies resulting from hydrolysis of the chromogenic substrates.

• Ethicon Products, a division of Ethicon (Somerville, New Jersey), reported the results of a study demonstrating that the company's Ultrapro Partially Absorbable Lightweight Mesh provides high initial burst strength during the critical time period of tissue-mesh incorporation. The data also demonstrates that following tissue incorporation, the lightweight mesh maintains a mean burst strength comparable to midweight polypropylene mesh, while becoming less stiff than heavier meshes. The investigators concluded that the findings may contribute to more physiologic abdominal wall compliance after long-term implantation of the lightweight mesh. The study data was presented at the recent Association for Academic Surgery meeting in Houston.

• Infectech (Sharon, Pennsylvania) reported that it has filed with the FDA to begin the production, marketing and commercialization of its biophasic system devices intended to cultivate and identify certain pathogenic microorganisms. The devices contain one or more components that suppress the growth of certain microorganisms while either promoting or not affecting the growth of other microorganisms, and aid in the diagnosis of disease caused by the pathogenic microorganisms.

• StemCells (Palo Alto, California) reported the filing of its first investigational new drug application to the FDA. Subject to approval, the company plans to begin its first clinical investigation of its human neural stem cells (HuCNS-SC) product in Batten disease, a rare, fatal genetic disorder that affects the central nervous system of children. If approved by the FDA, this would mark the first-ever FDA-approved clinical trial to use a purified composition of human neural stem cells as the potential therapeutic agent. The proposed Phase I trial is designed to investigate the safety of HuCNS-SC in the treatment of infantile and late-infantile neuronal ceroid lipofuscinosis, the most severe forms of Batten disease. The trial will be an open-label study of two dose levels involving three subjects in each of two cohorts. The primary objective will be to measure the safety of HuCNS-SC. The trial will also will evaluate HuCNS-SC's ability to affect the progression of the disease. The patient/subject evaluation will be up to one year post-HuCNS-SC transplantation.

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