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Tissue, Cell Donors Screened Under New US Rule Reuters, 05.20.04, 3:09 PM ET By Maggie Fox, Health and Science Correspondent WASHINGTON, May 20 (Reuters) - Virtually all donated tissues and cells -- including sperm and stem cells -- or their donors, must be screened for diseases from syphilis to SARS under proposed new FDA regulations released on Thursday. Doctors, politicians and patient groups have been clamoring for the new rule, five years in the making. The pressure increased in recent years with the publicized deaths of patients who received infected transplants of seemingly innocuous tissue such as knee tendons and heart valves. Since 1993, the Food and Drug Administration has required that muscles and tendons, skin and eye tissue donations be tested for hepatitis B and C and for the AIDS virus. "Under this new rule, reproductive tissue (semen, ova, and embryos), hematopoietic (blood) stem cells derived from cord blood and peripheral blood sources (circulating blood sources as opposed to bone marrow), cellular therapies and other innovative products are also regulated," the FDA said in a statement. "In addition to including a broader range of tissues and cells, the new rule extends the scope of protection against additional communicable diseases that can be transmitted through transplanted tissues and cells," it added. These include the incurable brain-wasting Creutzfeldt-Jakob disease, syphilis and, for relevant tissues, human T-cell lymphotropic virus or HTLV, which is suspected of causing leukemia, and the bacteria that cause chlamydia and gonorrhea. NEW INFECTIOUS AGENTS The rule, which is open for comment, would also give FDA the option of imposing screening requirements for emerging new infections such as West Nile virus and Severe Acute Respiratory Syndrome. "This rule is a major step toward ensuring that tissue contaminated with life-threatening pathogens is not transplanted into unsuspecting patients," said U.S. Sen. Susan Collins, a Maine Republican who has led several hearings on tissue bank practices. "While I welcome this new rule, I remain perplexed by the FDA's repeated and unacceptable delays in implementing this rule. I am concerned that this delay may have put lives at risk," she added in a statement. Collins said there are now more than a million tissue transplants a year. They are known to transmit diseases such as gangrene, West Nile virus infection, CJD and AIDS. But Georgia-based CryoLife Corp. (nyse: CRY - news - people) has been targeted by dozens of lawsuits and FDA actions after selling tissues that later turned out to be infected with fungi and bacteria. In one case, a 23-year-old Minnesota man, Brian Lykins, died from an infection in 2001 after preventive knee surgery. "We now have new tissue technologies that hold the potential to provide treatments for diseases such as cancer, Parkinson's disease, hemophilia and many other serious conditions," said acting FDA Commissioner Dr. Lester Crawford. The FDA said its new rules do not include whole organs or bone marrow that has not been manipulated, as both are already regulated by the Health Resources and Services Administration. It also does not cover blood products for transfusion or products derived from animals, which FDA regulates as biologics. The rule, which becomes effective on May 25, 2005, is available on FDA's Internet website at http://www.fda.gov/cber/rules/suitdonor.pdf SOURCE: Reuters News Service / Forbes http://www.forbes.com/business/businesstech/newswire/2004/05/20/rtr1379268.html * * * ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn