A district court ruled that the FDA can regulate the clinics that use stem cell-based therapies. The ruling now identifies stem cell as drugs. This decision ensures that stem cell therapies are subject to the FDA regulatory standards of other drugs, including that they are subject to the clinical trial process and have been approved for use. This ruling is especially important to ALS patients for two reasons, 1) many potentially promising ALS therapies are based on stem cells, and 2) there has been an unfortunate recent history of unregulated, unsafe, and disreputable stem cell treatments being offered to ALS patients.
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