California, Florida stem cell clinics target of US lawsuit

FDA Cracks Down on Stem Cell Clinics But Patients Are Still at Risk

Comments by Dr. Mike are in Bold

The firms put consumers at risk by promising benefits from treatments and products never approved by the Food and Drug Administration, the Justice Department alleged in court filings in both states.

LOS ANGELES — Federal prosecutors in California and Florida sued on Wednesday to stop two companies from providing stem cell treatments, alleging the clinics marketed their procedures as remedies for ailments including cancer and heart disease without proof of safety and efficacy.

Comment: In medicine, there are never any guarantees. The FDA basically took ownership of a word in our dictionary: cure. According to the FDA only drugs can cure. Therefore, any product or food item or therapy cannot claim it cures anything and a disclaimer is needed to promote those products or items or therapies. On the other hand, it’s not prudent for stem cell clinics to market their therapies as a remedy, unless peer reviewed and scientific published evidence shows there may be benefits and the product and procedure are safe. The job of the FDA is to protect the public from potential harmful drugs, products and procedures. In this case, it may be doing its job (see below) while in most instances it allows for harmful drugs, vaccines and treatments to enter the marketplace.

The firms put consumers at risk by promising benefits from treatments and products never approved by the Food and Drug Administration, the Justice Department alleged in court filings in both states.

Comment: The FDA only approves drugs. Therefore, it’s impossible to receive FDA approval for this procedure. However, the FDA regulates HCT/P’s (Human Cellular Tissues and products) under Section 361. These clinics therefore need to adhere strictly to the regulations set forth by the FDA in section 361.

The complaints involve cells taken from patients’ own fat tissue. It’s a growing practice where practitioners collect the fluid from patients via liposuction, treat it with chemicals and then inject it back into the body to treat various conditions.

The use of adult stem cells (patient’s own fat or bone marrow) is outdated and has many disadvantages:

Adult stem cells are currently in wide use for a broad range of clinical applications. These cells are usually derived from autologous (from patient) bone marrow or fat cells, which are extracted in one procedure, isolated, treated and amplified, and then reinserted to the target pathological area through another interventional procedure.

There exists a wide variety of methods by which the cells are isolated, treated and amplified.  These can vary even from procedure to procedure within a single clinic.  Most of these processes are proprietary, and many are protected by patent.  As a result, there is no simple way to determine if a procedure or a particular application has clinical validity.  Much of the information available takes on an air of being anecdotal, and resistant to investigation through rigorous scientific method.  Most, if not all, of the current clinical use of adult stem cells in the United States would fall under this rather inauspicious descriptor.

Besides the fact that the use of adult stem cells is non-standardized, and there’s no uniformity and no quality control, the application requires a surgical intervention to harvest the stem cells. This surgical intervention increases risk (as with any surgery) and increases the cost to the patient.

Furthermore, the results are NOT CONSISTENT. That’s because these adult stem cells may lack the 3 essential components necessary for a successful tissue engineering: Growth factors (GF’s), Bio-active molecules and collagen scaffold. In addition, Scientific research clearly shows that the number of

adult stem cells drastically declines with age, so often not enough healthy cells can be harvested. In addition, these adult stem cells are low in quality, in other words their ability to replicate is diminished. These adult stem cell procedures rely on the quantity and quality of the patients’ own stem cells which are low in number and quality, hence many patients do not get the results they were looking for.

The lawsuits target Stem Cell Treatment Center, with two locations in Southern California, and U.S. Stem Cell Clinic of Sunrise, Florida.

Mark Berman, co-director of the California clinics, said he stands by his treatments and looks forward to fighting the lawsuit. He said the government had outdated views of stem cell research.

“The idea that we’re doing something dangerous is erroneous,” Berman said.

U.S. Stem Cell said in a statement that it would “vigorously” defend itself in court.

“I remain steadfast that no government agency should deprive individuals of their right to harness the cells that exist in their body,” said Dr. Kristin Comella, the Florida company’s chief science officer.

According to the complaints, the defendants used their products on thousands of patients without first obtaining necessary FDA approvals. The clinics claim the procedures can treat ailments including cancer, pulmonary disease, arthritis, stroke, Parkinson’s disease, spinal cord injuries and traumatic brain injury.

The court filings allege that that in some cases patients suffered “adverse events” including infections that required hospitalization and, in at least one instance, retinal detachments after receiving eye injections.

Comment: These clinics seem rather careless since infections can be prevented when following universal precautions. However, the risk of infection obviously increases with a surgical intervention. Again, these types of stem cell therapies are outdated and pose unnecessary risk to the patient while providing inconsistent results. Today, stem cells can be safely and effectively sourced from umbilical cord tissue. Stem cells from umbilical cord tissue (Wharton’s Jelly) are much higher in quantity and quality and have many proven advantages over the use of adult stem cells.  

The suits were filed at the request of the FDA, officials said. Last year the FDA laid out a strategy for regulating cell-based medicine, including hundreds of private clinics that have opened across the nation in the last decade. Many of the businesses promote stem cell injections for dozens of diseases. They can cost $5,000 to $50,000, but there’s little research that such procedures are safe or effective.

Stem cells have long been recognized for their ability to reproduce and regenerate tissue. And while emerging research suggests that they will eventually be used to treat a range of debilitating diseases, they are currently only approved for a handful of medical procedures. For instance, adult stem cells from bone marrow transplants have long been used to treat leukemia and other blood diseases.

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