Illegal stem cell therapies injure 12 people

January 14, 2019

At least a dozen people were hospitalized in 2019 for infections related to unapproved stem cell therapies, the Centers for Disease Control and Prevention reported.

Patients in multiple states were injected with umbilical cord blood stem cells produced by a California company. One patient spent 58 days in the hospital with a bloodstream infection and spinal problems; another was hospitalized for 30 days with an infected knee The New York Times reported.

The CDC report noted that its investigation “highlights the serious potential risks to patients of stem cell therapies administered for unapproved and unproven uses.”

The only FDA-approved use for stem cells is part of the treatment for leukemia and lymphoma. The FDA warned the maker of the unapproved therapy, Genetech Inc. of San Diego, as well as at least 19 other companies about providing stem cell therapies without FDA approval.

“These clinics prey on people’s hopes of a cure or treatment and actually harm the patients,” said Scott Jones, Vice President for Scientific Affairs at BioBridge Global. “These rogue clinics not only affect the patients directly, but they also tarnish the name of legitimate stem therapies like we are enabling here at BBG.”

BioBridge Global only works with researchers dedicated to following FDA guidelines from beginning to end, Jones said.

“Places like BBG are working to help develop and manufacture real stem cell therapies, ones with scientific data to show their efficacy and that can treat and possibly cure human ailments,” he said.

Earlier in 2019, the FDA sought permanent injunctions against two clinics for unapproved stem cell therapies. In 2017, three patients of a Florida clinic were blinded after stem cells were injected into their eyes. A California clinic was administering a combination of smallpox vaccine and stem cells to cancer patients.

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