FDA Raids One Stem Cell Lab and Warns Another in Regulatory Push
- Agency to get tough on those touting unproven cell therapies
- Regulator to help legitimate developers gain sales approval
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U.S. health authorities will more closely regulate a burgeoning, and sometimes unproven, field of medicine that employs the body’s own cells or tissues to help treat a wide variety of diseases or conditions.
On Monday, the Food and Drug Administration released a warning letter it sent last week to Florida-based U.S. Stem Cell Inc. for selling unapproved stem-cell treatments and injecting them into patients’ spinal cords. And it raided a San Diego-based stem cell treatment center and seized vials of a live virus typically reserved for people at high risk of smallpox that was being mixed with stem cells and injected directly into cancer patients’ tumors.