FDA issues Zika recommendations for cell and tissue donation

The FDA released new guidelines on March 1st to decrease the potential transmission of the Zika virus through the donation of human cells, tissues, and cellular and tissue-based products (HCT/Ps). The non-binding recommendations apply to living and deceased donors of umbilical cord blood, placenta, and other gestational tissues. “Though there is more to be learned about the transmission of Zika virus, given what we know about the virus at this point, which also is informed by our understanding of similar viruses, we must address the potential risk of Zika virus transmission by human cells and tissues,” director of the FDA’s Center for Biologics Evaluation and Research Peter Marks said in a press release. “Providing HCT/P establishments with donor eligibility recommendations will help reduce that potential risk.”

In theory, the risk for Zika transmission by HCT/Ps – which also include corneas, bone, skin, heart valves, hematopoietic stem/progenitor cells (HPCs) from cord blood and peripheral blood, and reproductive tissues such as semen – exists. By way of example, “the virus was detected in semen 62 days after onset of symptoms in one individual, and possibly up to 10 weeks after onset of symptoms in a different individual,” the FDA document says. Moreover, Zika has also been found in amniotic membranes and fluid. In fact, a study published in The Lancet suggests that the virus can cross the placental barrier and infect a fetus. The new guidelines are the latest installment in the FDA’s efforts to reduce the risk non-mosquito Zika transmission, following a set of recommendations to decrease the risk Zika blood transfusion transmission.

Recommendations for Living Donors of HCT/Ps

Living donors should be considered ineligible if they have:

1.       Been diagnosed with Zika infection in the past six months.

2.       Resided in or traveled to an area with active Zika transmission in the past six months.

3.       Had sexual relations in the past six months with a male who has either 1 or 2.

donors of umbilical cord blood, placenta, or other gestational tissues should be considered ineligible if the birth mother who seeks to donate gestational tissues has:

1.       Been diagnosed with Zika infection at any point during pregnancy.

2.       Resided in or traveled to an area with active Zika transmission at any point during pregnancy.

3.       Had sexual relations at any point during pregnancy with a male who has either 1 or 2 in the above list.

Recommendations for Deceased Donors of HCT/Ps

Deceased donors should be considered ineligible if they were:

1.       Diagnosed with Zika infection in the past six months.

 

The six-month deferral period was decided on due to the dearth of knowledge regarding how long the virus can linger in all tissues. There is still a lot that experts do not know about the Zika virus. There is no cure and no vaccine has been developed yet. The only treatment consists of relieving the pain and fever characteristic of the infection. Unfortunately, the virus has also been linked to cases of microcephaly in Brazil, and of Guillain-Barre syndrome in other Latin American countries.

Related: Instructions for diagnostic testing of the Zika virus