Save our stem cells, patients ask judge in FDA case
Frank Poucher, a retired Air Force colonel from California, insists that the two stem cell treatments he has received for his Stage 4 congestive heart failure helped him regain his quality of life.
“If it wasn’t a miracle, it was a remarkable improvement,” the 79-year-old said in an interview. Many physicians, scientists, and regulators from the U.S. Food and Drug Administration would disagree, saying there’s no proof stem cell treatments work as marketed for any of a wide variety of conditions.
Poucher is one of about 100 clients of Sunrise-based U.S. Stem Cell and associated clinics who are seeking to amend a court ruling that ordered the destruction of all of their stored stem cell tissues by July 25.
The order was part of an June 25 injunction by U.S. District Judge Ursula Ungaro to permanently stop the clinic from marketing stem cell treatments that have not been approved by the FDA.
The FDA sought the injunction in May 2018, saying U.S. Stem Cell failed to heed earlier warnings to stop marketing stem cell treatments that have not been subjected to clinical drug trials.
U.S. Stem Cell, the FDA said, was processing body fat into a stem cell product and injecting it intravenously and directly into the spinal cord of patients to treat a variety of serious diseases or conditions, including Parkinson’s disease, amyotrophic lateral sclerosis (known as Lou Gehrig’s disease), chronic obstructive pulmonary disease, heart disease and pulmonary fibrosis.
Thousands of patients received the unapproved treatment, the U.S. Department of Justice said. Several suffered adverse consequences. Three elderly women with macular degeneration lost their vision after having stem cells injected into their eyes in June
2015. The clinic stopped eye injections after their cases were publicized but continued using the procedure for other conditions.
U.S. Stem Cell sent statements to its patients notifying them that the injunction prohibits the company from receiving, processing and distributing tissue-derived stem cells. The company also said it was required to destroy the stem cells stored in its tissue bank within 30 days of the June 25 ruling “unless this injunction is modified.”
The statement directed patients to speak with their personal attorneys or write to the court “if you wish to be heard on this destruction order.” In a follow-up letter to patients, the company provided the name of an Aventura-based attorney familiar with the injunction in case they decided to contest the destruction order.
Since the order, 94 letters have been sent to the federal court overseeing the case in Miami, according to the case file accessible through the court’s online filing system. Five letters were added to the file prior to June 25.
Letter writers include Josephine Spataro, of Danville, Calif., who wrote that two stem cell treatments left one of her knees “free of pain and completely functional” compared to her other knee “which is still somewhat painful” three years after a conventional knee replacement.
Another letter, from Genevieve Fleischman of Fort Myers, said recurring stem cell treatments have resulted in improvements for a friend with ALS, a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord.