A US federal court has found that stem cell therapy offered by a Colorado clinic meets the definition of a regulated drug. The decision could stimulate repression US Food and Drug Administration on other clinics offering treatments of adult stem cells are not tested in the United States.
The company, Regenerative Sciences Inc. in Broomfield, Colorado, uses stem cells extracted from bone marrow of a patient to treat bone and joint injuries. The company says that its treatment is a medical procedure and not subject to federal oversight. But in a suit in 2010 seeking to block the company to sell the treatment, the US government argued that because science regenerative stem cells are more than "minimal manipulation" and reagents for use that cross state lines, the cells are a biological medicinal FDA regulated.
On July 1 decision 23 (the first time by New Scientist ), the US District Court for the District of Columbia in Washington, DC, agreed that "the product of cultured cells is a drug "under federal law.
The decision could have implications for stem cell clinics in Texas. In April, the Texas Medical Board approved the first policy of the State to supervise the treatment of experimental stem cells. Critics said the policy would allow doctors to avoid scrutiny. But an official of the board, showing the current suit against Regenerative Sciences, said state rules were necessary because of the uncertainty of the FDA authority to regulate stem cells.
CellTex, a stem cell bank in Sugar Land, Texas, involved in the treatment of Gov. Rick Perry (R-TX) with his own stem cells last summer, also said its cells that it provides are not an experimental drug. In June, however, the FDA found problems with the CellTex manufacturing process and describes its product as a biological drug.
University of Minnesota bioethicist Leigh Turner said the court decision this week "is particularly important given that we are seeing in the United States the proliferation of clinical stem cell procedures of marketing," many of which "appear to be push the quackery of stem cells, "he said.
Science regenerative CEO Christopher Centeno said New Scientist that the company plans to appeal.
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