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Regenerative Sciences, LLC
Regenerative Sciences, LLC or Regenerative Sciences, Inc. is a Colorado company based in Broomfield, Colorado where two doctors, Dr. Christopher Centeno and Dr. John Schultz operate a small medical clinic. In this clinic, they offer a treatment called "Regenexx-C." The goal of this treatment is to use the stem cells of the patient to repair the damaged bone and cartilage. There are two things that are needed from the patient for this treatment to occur. First, a bone marrow must be extracted from the patient's hip using a needle. Second, blood must be drawn from the patient's arm. There are growth hormones in the patient's blood that can be used to accelerate the growth of stem cells that are from the bone marrow. The patient's bone marrow and blood is then sent to a Regenerative Sciences Lab where the physician's goal is to multiply the stem cells. This process takes about 7 days. After 7 days, the newly grown stem cells are reinjected back into the injured area of the patient.

It should be noted that Regenerative Sciences, LLC charges $7000-9000 for the treatment.

History
In the late 1990s FDA proposed regulating more than minimally manipulated (MAS Cells) cells as drugs. Public hearings were held which led to significant opposition from industry, professional groups, and academia. For example, the American Red Cross submitted written testimony that it opposed the FDA's position that cells should be regulated as drugs, instead proposing they be regulated as medical devices. The American Society of Clinical Oncology stated in their written testimony, "ASCO objects in the strongest terms to FDA's proposed regulation of stem cell transplants. This misguided proposal is unnecessary, would jeopardize the proper treatment of cancer patients and impede the development of new therapies, would substantially increase the cost of stem cell transplants, and exceeds FDA's legal authority." Northwestern University also opposed this new regulatory schema, as did other groups such as the Biotechnology Industry Organization, Reprogenesis, Osiris Therapeutics, and the Society for Assisted Reproductive Technology.

In 2005-6, Regenerative Sciences obtained multiple legal opinions that their planned use of autologous, cultured bone marrow in their own patients was the practice of medicine. In 2006, the FDA made a one word change in its 21 CFR 1271 regulations, changing the wording from "into another human" to "into a human", thereby extending its regulatory authority over autologous stem cell therapies. In 2007 Regenerative began offering the cultured stem cell service to patients. In July 2008, Regenerative received an Untitled letter from the Food and Drug Administration Center for Biological Evaluation and Research which stated the Regenexx-C Procedure may not in compliance with the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. '''More specifically, the FDA considered Regenerative Sciences' Regenexx-C to be a drug under section 201(g) of the FDCA and under section 351(i) of the PHSA to be a biological product which means that the FDA has the authority to regulate Regenexx-C. Furthermore, the company failed obtaining a BLA or filing an IND. ''' Regenerative responded in writing and asked for an administrative hearing with the FDA on the issue, which was denied. In 2009, Regenerative sued FDA in Denver District Court over the issue of whether the FFDCA allowed the FDA to regulate a small medical practice like a drug manufacturer. FDA claimed in court documents that it had not yet taken "final agency action" on the matter. As a result, judge Wiley Daniels ruled that the case was not ripe for judicial review.

In August 2010, The FDA filed for an injunction that would prohibit Regenerative Sciences from continuing to provide the Regenexx-C Procedure. Regenerative advanced a counterclaim holding that the Regenexx-C Procedure should not be subject to FDA regulation because, as a medical procedure, it is not a drug but part of the practice of medicine. Further, they argued that if it was found to fall within federal regulation, then it would still be found exempt of manufacturing and labeling requirements of the Federal Food, Drug, and Cosmetic Act. The U.S. District Court for the District of Columbia rejected the counterclaim and upheld the injunction. Regenerative Sciences appealed.

Culture During the Case
Overall, the dispute between the FDA and Regenerative Sciences received little to no attention from the mainstream media, however, there were articles, comments from the public and patients, internet reports that commented on this case. With the FDA's position on regulating stem cells, the perspective seems to be that the costs of stem cell therapy will increase because of the new regulations that will be put into place which means that developing new stem cell therapies will increase. The public also believed that the FDA was acting on the interests of "Big Pharma," as mentioned, only they can develop new stem cell therapies or that having stem cell therapies will block the Big Pharma profits. Moreover, there were some that believed that the FDA was violating the liberty of the people because the government was trying to control what a person can and can not do to their own body. In addition to the general public, the media had a largely positive view of stem cell therapies, citing procedure as proven to be safe when no factual evidence has been provided and only anecdotal evidence or testimonies have been given. There was also a growing phenomenon that stem cell therapies were a natural product akin to essential oil and not a drug. In general, the public had a positive view of stem cell therapy and disliked the FDA's position on regulating autologous cells.

FDA Claims
1) The FDA claimed that the Regenexx-C Procedure falls under the regulation of the FDA because it is a "drug." In addition, the Regenerative Sciences' Website mentions that this procedure is intended to cure the injured area of the patient. According to the FDA, the way Regenerative Sciences marketed the Procedure shows that   the Procedure is indeed a drug. Citing examples such as "prevents the need for surgery," "an Alternative to Traditional Surgery," and "shown to be safer than traditional surgery techniques..." Moreover, the FDA claims that Regenexx-C Procedure is a prescription drug because the procedure requires a licensed physician to execute the drawing of blood and bone marrow, growing the stem cells, and reinjecting the stem cells back to the patient. Additionally, experts of stem cell therapies do not formally recognize the Procedure as safe or effective at all because the FDA claims that no studies have been demonstrated to prove the effectiveness of Regenexx-C Procedure. As such, the FDA identified the Product as a "new drug." Because of this, the FDA states that Regenerative Sciences failed to file a NDA or an IND when the company was developing the new Procedure.

2) The FDA claimed that under PHSA, Regenexx-C Procedure is a "biological product." Because Regenexx-C Procedure can be used to treat multiple conditions of the human body such as arthritis and bone fractures, Regenerative Sciences failed to file a BLA which is needed for "biological product."

3) The FDA argued that Regenexx-C Procedure did not qualify to be exempted from a pre-market review and that the product should have been reviewed before hitting the market. Moreover, an IND, NDA, and a BLA should have been filed by Regenerative Sciences. The FDA also concludes that because the procedure involves many steps such as blood drawing, extracting a bone marrow, the mixing of growth hormones with the stem cell, the cells that undergo the Procedure is considered to be a more than minimally manipulated cell which is subject to stricter section 351 regulations.

4) The FDA argued that the Regenexx-C Procedure is an adulterated drug meaning that it is rendered to be of inferior quality. When the FDA inspected the facilities of Regenerative Sciences two times back in 2009, the FDA allegedly found violations of cGMPs, current Good Manufacturing Practices, such as failing to exhibit procedures preventing contamination.

5) The FDA accused Regenerative Sciences of misbranding the Regenexx Procedure because the FDA found adult stem cells in plastic bags that were labeled with "drug" like directions and furthermore, because the FDA labels the Regenexx-C Procedure as a prescription drug product, the company failed to label the product with "Rx only."

Regenerative Sciences, LLC Claims
1) Regenerative Sciences argued that the procedure of Regenexx-C, in which bone marrow and blood is taken from a patient, and stem cell is grown, is a medical practice which means that the FDA has no authority at all to oversee the procedure. Furthermore, the company argues that under Section 361, the FDA has no authority to regulate the procedure as a biological product or a drug.

Decision
On February 4, 2014, the United States Court of Appeals for the District of Columbia Circuit affirmed the district court’s injunction against Regenerative Sciences’ use of the Regenexx-C Procedure and also dismissed the counterclaims. '''The counterclaim that the use of stem cells was practice of medicine was rejected by the court because the FDA oversees the medical practice of physicians. The court also mentioned that FDA can regulate the stem cells due to the possibility of spreading diseases. Furthermore, because the stem cells went under the Regenexx-C Procedure, the court found that the stem cells are "more than minimal manipulation" which puts them under the authority of the FDA as a biological product or a drug.''' The court also found that the mixture used in Regenexx-C could not be exempted from manufacturing and labeling requirements of the Federal Food, Drug, and Cosmetic Act as a compound drug because mesenchymal stem cells have not been FDA-approved as components for use in compound drugs. Having rejected the counterclaims and establishing that the Regenexx-C mixture is both a drug and subject to FDA regulation, the court then found that these regulations had been violated, and upheld the injunction.