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Fraudulent Stem Cell Practices Lead To FDA Warning

Stem cell research continues to be one of the most debated practices of the 21st century. While many suggest that such research is unethical, proponents profess that the benefits of stem cell research are limitless in their possibilities. While their nature remains ambiguous, stem cell therapies offer patients the potential to treat conditions that are currently ravaging the globe. However, representatives at the U.S. Food and Drug Administration (FDA) are worried that such a promising future may leave patients vulnerable to seedy providers of stem cell treatments that are illegal and potentially harmful.

Stem cells, otherwise referred to as the body’s “master cells,” are the precursor for future cells that will eventually develop into blood, brain, bones, organs and every other physical aspect of the human body. These distinct cells are found in all multicellular organisms and have the ability to divide into diversely specialized cell types with renewal capabilities. Therefore, stem cells are tasked with repairing the body and replenishing adult tissue. Subsequently, research has suggested that such a mechanism of action may be transitioned over to medical applications.

Their potentially ground breaking future in medical treatment is due to their ability to repair, restore, replace and regenerate damaged cells. While still in the initial stages of testing, stem cell research is on the brink of a significant breakthrough. The FDA has currently endorsed and approved one stem cell product. Known as Hemacord, this product is a cord blood-derived treatment manufactured by the New York Blood Center and used for specified indications in patients with disorders affecting the body’s blood-forming system.

The success demonstrated by Hemacord suggests that future stem cell research has the potential to alter the foundation of the medical community. Accordingly, several stem cell treatments are currently in the beginning phases of pre-market testing. With so many potential options for stem cell treatment, the FDA has cautioned consumers to make sure that any stem cell treatment they are considering has been approved by FDA or is being studied under a clinical investigation that has been submitted to and allowed to proceed by FDA.

The FDA is concerned that the hope that patients have for cures not yet available may leave them vulnerable to unscrupulous providers of stem cell treatments that are illegal and potentially harmful. Therefore, the FDA has suggested to seek FDA approved treatments only.

According to Stephanie Simek, Ph.D., deputy director of FDA’s Office of Cellular, Tissue and Gene Therapies, the FDA regulates stem cell therapies to ensure that they are safe and effective. Simek acknowledges that stem cells can “come from many different sources and under the right conditions can give rise to many different cell types.” Therefore, it is important to gain a better understanding of their ambiguous nature before treatments are implemented.

Current practices witness doctors extract umbilical cord blood from the placenta. Following extraction, the cells are then isolated, processed, and frozen and stored in a cord blood bank for future use. The extraction and use of cord blood is a regulated process that is presided over by strict FDA and cord blood bank rules.

However, similar stem cell products do not share the same level of regulation. Several stem cell products, including those of cord blood nature, are currently in the process of investigational studies. Investigational products undergo a thorough review process as the sponsor prepares to study the safety and effectiveness of the product in adequate and well-controlled human studies. Clinical trials such as these are intended to provide consumers with a safe product without the potential for adverse complications.

Unfortunately, there is significant evidence that medical practitioners are applying stem cell therapy without approval from the FDA. Such a practice demonstrates a propensity for danger and disregard for public safety.

As recent as December 2011, three men were arrested in the United States and charged with 15 counts of criminal activity related to manufacturing, selling and using stem cells without FDA sanction or approval.

According to an FDA Consumer Update a licensed midwife who operated a maternity care clinic in Texas, obtained umbilical cord blood from birth mothers, telling them it was for “research” purposes. Instead, the midwife sold the cord blood to a laboratory in Arizona which, in turn, sent the blood to a paid consultant at a university in South Carolina. The owner of the laboratory in Arizona was convicted in August 2011 of unlawfully introducing stem cells into interstate commerce. She faces up to 3 years in prison and a fine of up to $10,000.

Subsequently, the consultant used university facilities to manufacture stem cell products. He then proceeded to send the products back to the lab, who in turn sold them to a man claiming to be a licensed physician. The man then traveled to Mexico to perform unapproved stem cell procedures on people suffering from cancer, multiple sclerosis and other autoimmune diseases.

The three defendants allegedly received more than $1.5 million from patients seeking treatment for incurable diseases.

“Scammers like these offer false hope to people with incurable diseases in order to line their own pockets with money,” says Special Agent in Charge Patrick J. Holland of FDA’s Office of Criminal Investigations (OCI), Kansas City Field Office. “FDA will continue to aggressively pursue perpetrators who expose the American public to the dangers of unapproved stem cells and ensure that they are punished to the full extent of the law.”

Do I Have a Stem Cell Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in stem cell lawsuits. We are currently accepting new cases in all 50 states.

If you or a loved one has been injured by the malpractice of stem cell therapy, you may be entitled to financial compensation. For a free case review, please click the link below or call toll free 24 hrs/day 1-800-773-0849.

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