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A federal judge on Monday sent a blow to justice fast growing the stem cell industry, serving the Food and Drug Administration as part of its efforts to stop treatment at US Stem Cell, a clinic in Sunrise, Florida, which blinded three patients by injecting a fat extract in the eyes.
The decision does not close the clinic but indicates that the F.D.A. has the power to regulate it and is entitled to an injunction against it. Judge Ursula Ungaro of the United States District Court for the Southern District of Florida is expected to issue a new ruling shortly specifying measures to be taken against the clinic.
American stem cells practice liposuction on patients to suck belly fat, transform fat to extract what it describes as stem cells, and then reinject the extract to patients. He said the process could treat neurological, autoimmune, orthopedic and degenerative diseases, including Parkinson's disease, amyotrophic lateral sclerosis (also known as ALS or Lou Gehrig's disease), lung diseases, back diseases, back pain, arthritis and others.
The clinic is one of hundreds of poorly regulated stem cell companies that have grown across the country and offer to treat a large number of diseases. Some use fat cells, some use the patient's bone marrow or platelets, and some use cord blood or other birth tissues such as amniotic membranes.
The industry has grown so fast that it has barely been able to keep up. The agency has focused on the so-called bad actors who have harmed patients or who have endured dangerous acts that may well hurt someone.
The F.D.A. applied for a permanent injunction against US stem cells in May 2018, with the aim of preventing it from commercializing stem cell products without F.D.A. approval. Patients who became blind received the injections in 2015 and their case attracted public attention in 2017. Monday's court decision does not mention these cases, but it is reported that multiple inspections have revealed that the company had violated the rules of good manufacturing practices even after the warnings.
The company and its scientific leader, Kristin Comella, argued that because she was treating patients with their own cells, the F.D.A. did not have regulatory authority. The agency disagreed, saying the cells were heavily transformed and altered from their natural state, making them similar to drugs, which the F.D.A. does not regulate. The judge sits on the side of the F.D.A.
US stem cells did not immediately respond to a request for comment.
"We have taken steps, like this case, against clinics that abuse patients' trust and put their health at risk," said F.D.A. The spokeswoman, Stephanie Caccomo, said in a statement. "We will continue to promote the healthy and scientific development of regenerative medicine products, but we will not tolerate those who try to circumvent the law and put patients at risk in this area."
Scott Gottlieb, who was F.D.A. The director, when the agency sought the injunction, said the decision was very important and said it provided "a strong legal basis for the F.D.A. to intervene and take much more robust measures. He adds, "It sends a strong message to people who straddle the line that they can not cross it. "
In her decision, Judge Ungaro said: "The Court agrees with the F.D.A. that it is reasonably probable that the defendants will continue to violate the Food, Drugs and Cosmetics Act. "
The F.D.A. has also sought a permanent injunction against another stem cell company, Cell Surgical Network, based in Beverly Hills, California, and has dozens of affiliates in the country. This case is ongoing.
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