After years of legal wrangling, the US District Court in Washington, DC, last week upheld the Food and Drug Administration's power to regulate adult stem cell treatments in which the cells are more than "minimally manipulated" before being injected back into the patient. The court ruled that the FDA was operating within its legal mandate when it filed suit against Colorado-based stem cell treatment clinic Regenerative Sciences in 2010 to stop them from extracting, processing, and then reinjecting patients' own bone marrow stem cells to treat bone and joint disorders.
The FDA argued that the treatment fell under its purview and was subject to approval like any new drug because the extracted cells were significantly modified using reagents that cross state lines. Regenerative Sciences disagreed, characterizing the treatment as a simple medical procedure, which don’t require FDA approval. The court sided with the FDA, making similar stem cell clinics popping ...
