Colorado-based Regenerative Science lost the first round when a U.S. District Judge ruled in favor of the U. S. Food and Drug Administration’s position that the company’s stem cell therapy is a drug. Attorneys representing Regenerative Science filed a notice of appeal earlier this month. According to Stephanie Baum, writing August 3 for Medcity News, the case is being closely watched by everyone with an interest in the use of stem cells in medicine. The case has ramifications for stem cell entrepreneurs who do not believe their treatments, using stem cells, amount to the administration of a drug or a biologic.
Regenerative Science has promoted its Regenexx procedure as an alternative to traditional surgery that can treat fractures that have failed to heal, joint cartilage problems, partial tears of tendons, muscles, or ligaments. To treat its patients, a physician takes a small bone marrow sample from the back of the patient’s hip through a needle and blood samples from a vein in the patient’s arm. The samples are sent to the Regenerative laboratory where the mesenchymal stem cells are isolated from the bone marrow and grown to greater numbers using growth factors in the patient’s blood. The stem cells are ultimately injected back into the relevant area in the patient.
In 2008 the FDA sent a warning letter to Regenerative after seeing its website. The company sued the FDA and, two years later, the FDA sought an injunction to shut it down. Andrew Ittleman of Fuerst Ittleman, part of the legal team representing Regenerative Science, said that the ruling doesn’t really change anything in the big picture of stem cell policy. “If anything [the decision] preserves the status quo, but the problem with that is that there’s so much uncertainty regarding what doctors can do and can’t do.”
Baum notes that the source for the debate comes from the regulatory framework the FDA set up in 2001 in response to the growth of research and medical treatments using human cells and tissues. The stated purpose at the time was “to improve protection of the public health without imposing unnecessary restrictions on research, development, or the availability of new products, ” according to court documents quoted by Baum.
One of the restrictions imposed was that human cell or tissue could only be minimally manipulated, which the FDA defined as “processing that does not alter the relevant biological characteristics of cells or tissues.” As Baum noted in Medcity News, if Regenerative Science ultimately loses it could lead to a significant decrease in the number of stem cell companies prepared to pay for the years of development needed to gain FDA approval for a drug or biologic. “Having members of the stem cell industry work with the FDA to hammer out some more coherent regulations could better fill the perceived gaps between the medical industry and drug and medical device companies, ” she wrote.
