Q Fever Outbreak Among Travelers to Germany Who Received Live Cell Therapy — United States and Canada, 2014

Misha P. Robyn, DVM; Alexandra P. Newman, DVM; Michael Amato, MPH; Mary Walawander; Cynthia Kothe; James D. Nerone; Cynthia Pomerantz; Casey Barton Behravesh, DVM; Holly M. Biggs, MD; F. Scott Dahlgren, MSPH; Emily G. Pieracci, DVM; Yvonne Whitfield, MPH; Doug Sider, MD; Omar Ozaldin, MSc; Lisa Berger, MD; Peter A. Buck, DVM; Mark Downing, MD; Debra Blog, MD

Disclosures

Morbidity and Mortality Weekly Report. 2015;64(38):1071-1073. 

In This Article

Discussion

The treatment known as live cell therapy was developed in Switzerland during the 1930s by Paul Niehans. Practitioners have used organs, glands, and fetuses of multiple species, including sheep, cows, and sharks*.[1]

No published clinical evidence supporting therapeutic claims of the treatment known as live cell therapy is available. It is advertised as having anti-aging effects and as a treatment for multiple conditions and diseases (e.g., erectile dysfunction, depression, and joint, neurologic, heart, kidney, lung, endocrine, and liver disease). Serious adverse events have been reported, including anaphylaxis, vasculitis, encephalitis, polyradiculitis, clostridial infections, paresis, and death.[3–5]

The treatment known as live cell therapy is a type of xenotransplantation when it involves administration of live cells from a nonhuman animal source into a human recipient.[6] Xenotransplantation carries a public health risk for transmission of known and unknown infectious agents from the donor organism to the human recipient and possible recombination or reassortment to form new pathogens.[6] There is a theoretic potential for dissemination of disease from the original recipient to others. For this reason, discussions on safety requirements for xenotransplantation by international and domestic public health agencies continue to occur.[7]

Regulation of xenotransplantation varies among countries. In the United States, the Food and Drug Administration (FDA) regulates xenotransplantation products as Biologic Drugs under section 351 of the Public Health Service Act§ and the Federal Food, Drug, and Cosmetic Act. FDA approval of a Biologics License Application (BLA) is required to introduce, or deliver for introduction, a biologic product into interstate commerce. FDA has not approved a BLA for a xenotransplantation product known as live cell therapy. If a xenotransplantation product is proposed for use in a clinical investigation in the United States, an Investigational New Drug Application would be required. In Canada, xenotransplantation cell therapy products are regulated as drugs under the Food and Drugs Act** and the Food and Drug Regulations.†† Authorities in Canada have not authorized for sale any xenotransplantation products, nor have any clinical trials that involve xenotransplantation been authorized. In Germany, xenotransplantation products are regulated under the Medicinal Products Act; however, an attempt to ban fresh cell therapy in 1997 was later determined to be null and void because the federal law does not cover drugs manufactured by doctors only for use in their own patients.[8] According to an assessment supported by the World Health Organization and its partners, during January 1994–September 2009, xenotransplantation procedures were identified in 12 different countries, of which nine had no clear national regulations on xenotransplantation.[9]

This outbreak highlights one of the public health issues associated with xenotourism, the travel outside a country of residence for the purpose of participating in xenotransplantation programs. FDA recommends that xenotransplantation product recipients enrolled in research studies remain under lifelong surveillance with periodic clinical and laboratory monitoring and that both they and their intimate contacts refrain from blood and tissue donation.[6] However, other than self-reporting, no method to identify returned xenotourists is available. Clinicians should be aware of xenotourism and consider the potential for zoonotic disease in a patient with a history of xenotransplantation.

*Additional information available at http://www.extendlife.com/livecell.php.
Additional information available at http://www.janson-mueller.de/index.php?id=22&L=2.
§42 U.S.C. 262.
21 U.S.C. 321 et seq.
*R.S.C., 1985, c. F-27.
††C.R.C., c. 870.

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