Posted on behalf of Meredith Wadman

Is it possible to catch a sexually transmitted disease from a transplant of reproductive-tract tissue? That gross-out possibility doesn’t seem too likely, the US Food and Drug Administration (FDA) was advised this week.

A panel of expert advisers to the US regulatory agency said on 14 May that, while rigorous data are lacking, epidemiologic and anecdotal evidence suggests that the transmission of Chlamydia trachomatis and Neisseria gonorrhoeae through products like amniotic membrane transplants used in eye surgery (pictured) are exceedingly slight.

“Any potential for transmission with these products would seem to be very low— acceptably low,” said panel member Emily Erbelding, an infectious-disease specialist at Johns Hopkins University School of Medicine in Baltimore, Maryland.

The agency had convened the panel to advise it on the potential for transmission of the two sexually-transmitted agents by products harvested from the reproductive system. The FDA does not currently require donor screening or testing for C. trachomatis or N. gonorrhoeae as it does for other infectious agents like HIV and hepatitis B and C. But recent growth in use of these products prompted it to seek expert advice. Amniotic membrane is used in treatment of leg ulcers, wound coverings and eye repairs. Placental cells and menstrual blood are sources of stem cells, as is umbilical cord blood. Placental cells are also used to replace damaged skin, and fibroblast cells from foreskin are used in treating diabetic foot ulcers.

While the panel was in general agreement about the low risk, it did not dissuade the agency from instituting a requirement that donors be screened — meaning having their medical history of the diseases taken – as opposed to tested for active disease. Currently some and perhaps all US companies voluntarily screen donors for the two diseases. But with products produced overseas — like umbilical cord blood, about one-third of which is imported – less is known about screening procedures.

“We are so new in this field and there is so much potential,” said Doris Taylor, an expert in cell and tissue therapy at the Center for Cardiovascular Repair at the University of Minnesota in Minneapolis. “Especially if a third of the products are coming from overseas…. I worry about the potential backlash if we do this wrong.”

Image: Bio-Tissue