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Tracking down tissues
FDA inspections of tissue banks remain a work in progress, and no clear path yet exists for procuring human tissues for biomedicine or drug development. Emily Waltz investigates.
http://www.nature.com/naturebiotechnology
Last years headlines about an underground trade in human body parts in New Jersey1
prompted a public outcry and the formation of the Human Tissue Task Force (HTTF)an internal US Food and Drug Administration (FDA) body with the specific mission of tightening the oversight of human tissue procurement. This summer, the HTTF released its first report, which identified several areas in need of improvement, such as tracking systems and more regular audits2. Two months later, FDA inspections of a few hundred (of several thousand) human tissue banking and procuring facilities revealed that the number of establishments with objectionable conditions had more than doubled (http://www.fda.gov/cber/ tissue/inspdata.htm). Although according to the FDA these situations pose little risk to human health, companies requiring human tissue for R&D still face a mlange of options in a supply system that is disorganized and scattered. And as the demand for human tissue grows, companies are having to find their own ways of collecting material and determining its quality.
Big demand
The HTTF was set up last year by the FDA after it discovered that a New Jersey tissue recovery company and several funeral homes were stealing body parts from the deceased, forging medical records and passing the tissues on to hospitals for transplant. The FDA closed down the company and the principals were indicted.
Experts say this kind of egregious abuse is driven largely by the great demand from the medical community for donated human tissuea demand that has increased rapidly over the past two decades. As drug discovery becomes increasingly target driven, scientists are finding more applications for human tissue. Nearly any scientist who tests drug candidates, harvests regenerative cells, makes delivery devices or creates bioimplants will likely have a use for donated human tissues.
But with the unpredictability of death and the reluctance of the public to donate, there often isnt enough tissue to go around. If supply wasnt a problem, human tissue would be used in every procedure out there, says Jamie Grooms, CEO of AxoGen...