Stem-cell injections linked to outbreak
NEW YORK (AP) — Health officials on Thursday reported an outbreak of bacterial infections in people who got injections of stems cells derived from umbilical cord blood.
At least 12 patients in three states — Florida, Texas and Arizona — became infected after getting injections for problems like joint and back pain, the Centers for Disease Control and Prevention said. All 12 were hospitalized, three of them for a month or longer. None died.
Investigators don’t think the contamination occurred at the clinics where the shots were given, because they found bacteria in unopened vials provided by the distributor, Yorba Linda, California-based Liveyon.
Liveyon voluntarily recalled the stem cells in October.
Last month, the Food and Drug Administration sent a warning to Genetech Inc., the small San Diego company that processed the stem cells. The FDA said the company should not be marketing the stem cells without regulators’ approval and has deviated from manufacturing requirements in ways that could have led to bacterial contamination.
Stem cells are very young cells than can develop into specialized cells, like blood cells, bone cells and brain cells. The cells are being studied as a potential way to treat many diseases and are currently approved for a handful of medical procedures. In recent years, hundreds of private clinics have opened promoting their use for diseases in which there is little evidence they are safe or effective.
Stem cells can be harvested from adults, but another source is umbilical cord blood, which can be collected at the time of birth, stored and used later.