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F.D.A. Can act against stem cell clinic, judge rules



A federal judge struck a blow on Monday against the fast-growing stem cell industry. He chose the Food and Drug Administration to discontinue treatment by US Stem Cell, a clinic in Sunrise, Florida.

The decision does not exclude the clinic, but states that the FDA is empowered to regulate this, and is entitled to a restraining order. The Judge, Ursula Ungaro of the United States District Court for the Southern District of Florida, is expected to take another decision soon to determine what action can be taken against the clinic.

Stem Cell liposuction patients to suck belly fat, processes the fat to extract what it calls stem cells, and then injects the extract back into the patient. It has been claimed that the method can treat neurological, autoimmune, orthopedic and degenerative diseases, including Parkinson's disease, Amyotrophic Lateral Sclerosis (also known as A. L. S. or Lou Gehrig's disease), lung disease, heart disease, back pain, arthritis and other problems.

The clinic is one of hundreds of loosely regulated stem cell companies that have sprung up across the country to treat a range of diseases. Some use cells from fat, others use the patient's own bone marrow or platelets, and others use umbilical cord blood or other birth tissue such as amniotic fluid membranes.

The industry has grown so fast that the F.D.A. could barely keep up. The agency focused its efforts on so-called bad actors who have harmed patients or who have been found to be carrying out risky procedures that are very likely to hurt someone.

The F.D.A. filed an injunction against US stem cells in May 2018 requesting the marketing of stem cell products without F.D.A. approval. The patients who were blind received the injections in 2015 and their cases received public attention in 2017. The Monday decision does not mention these cases, but it is found that several inspections have revealed that the company has violated good manufacturing practices and has not made any improvements, even after warnings.

The company and its scientific director Kristin Comella argued that it had treated patients with their own cells, the FDA, no regulator. The agency disagreed, arguing that the cells were heavily processed and altered from their natural state, making them similar to drugs used by F.D.A. regulates. The judge was on the side of F.D.A.

US. Stem Cell did not respond immediately to a request for comment.

"As in this case, we have taken action against clinics that abuse patient confidence and jeopardize their health," said F.D.A. Spokeswoman, Stephanie Caccomo, said in a statement. "We will continue to promote the solid and scientific development of regenerative medicine products, but we will not tolerate those in the field who are trying to circumvent the law and put patients at risk."

Dr. Scott Gottlieb, F.D.A. Director, when the Agency applied for the injunction, described the judgment as very important and said it "provides a firm legal basis for the F.D.A. to intervene and act much more determined. He added: "It sends a strong message to the people who cross the border, that they can not cross it.


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