Nearly 250 people visited the center last year. The center advertises that the initial round of stem cell injections will cost $7,200. A coordinator explained that most patients would have to pay the cost out-of-pocket during the initial phone call. The center’s stem-cell therapies will not be covered by insurance because they have not been approved or deemed effective by the Food and Drug Administration. According to a paper published in Cell Stem Cell this summer, the Gulf Coast Stem Cell Treatment Center was one of 570 clinics that sell expensive stem cell therapies to their customers. However, there is no scientific evidence to support these therapies working. The FDA held a public hearing last month on regulation of stem cells at National Institutes of Health. Many scientists called for the agency to crack down on unproven clinics. Dr. Vincent Herrin (associate professor and member of University of Mississippi Medical Center’s Hematology Care Team), said that “it’s not harmless.” This stem cell operation is accredited by the Foundation for Accreditation of Cellular Therapy. According to Dr. Jack Mosher (scientific affairs manager at International Society for Stem Cell Research), “It is important in medicine that you follow proven therapies or if something experimental it must be done through an established clinical study so…the patient is better protected that way.” Current approved adult stem cell treatments in the United States include stem cells taken from bone marrow and blood for certain cancers. He said that these treatments have been subject to a series of independent, rigorous clinical trials. Those who are labeled as “unproven” and “experimental”, have not. Patients are the ones who have voiced their disapproval at the FDA’s inspection of these clinics. Patients gave testimony about how the therapies helped them live normal lives during last month’s FDA hearings. Patients who claim that stem cell treatments have helped them with multiple sclerosis and lung disease, gave Gulf Coast Stem Cell 4.9 stars. Terrie Kieper (47), from Dallas, was diagnosed with MS in 2007. She left five stars. Terrie Kieper, 47, of Dallas, was diagnosed with MS in 2007. She left a five-star review. She said that three shelves in her kitchen cupboard had been used for pills back then to help her get through the day. “Just from the top of my mind, I was on my MS modifying medication Copaxone. Gabapentin was for tremors. I also took Xanax, Hydrocodone, Valium, and Valium for vertigo. I was also on Nuvigil for fatigue. Ambien CR was my CR. Kieper stated that Zomig was prescribed for my migraines. There was also another medication. “I said, “I’m going do this or I need to use a gun and a bullet.” Because I can’t keep going the same way. Copaxone, two years and two stem-cell treatments later, is her only prescription medication. “It’s hard to express my gratitude for Dr. Barmada when people ask me about him. Kieper stated that he saved my life. “I was in such pain. Barmada is full with anecdotes from other patients, like Kieper. He is unable to explain how these therapies work, even if they do. Barmada stated, “If I feel that I am benefiting someone else and they don’t have any light at the end the tunnel,” he said. Can you explain? “No, I can’t. It’s hard to explain and it still puzzles me. Is it possible that it is true? It is. It is true. Bienville Orthopaedic Specialists in Ocean Springs suspended stem-cell treatment and removed all information from its website shortly after the FDA hearings. Bienville spokeswoman for Bienville stated that she was not sure if it was because of increased FDA scrutiny, but that these treatments were not a major part of Bienville’s business. Erica Shrock (Director of Marketing for Bienville) stated that while it is not impossible for doctors to accept it back up, it is currently off the table. Stem cells have captured people’s imaginations over the past decade due to their extraordinary regenerative abilities. Mosher says that these “experimental clinics” have capitalized on the fact that stem cells are so powerful. More than a dozen stem-cell treatment centers have been opened in neighboring states since 2007, including three in Tennessee, eight in Arkansas, and two in Alabama. Mosher stated that the public has been misinformed about stem cells’ capabilities. Many of the healing properties that are attributed to stem cells are specific to embryonic stem cell, which are extremely rare, highly regulated, and highly controversial in the United States. Although adult stem cells are less tightly regulated, they have limited ability to regrow certain tissues. For example, a bone marrow stem cell is still immature. Herrin stated that it can be transformed into many different blood cells but not into brain tissue, kidney tissue, or nerve tissue. So stem cells taken from adults cannot be used to make anything. However, I believe people think they can. Mosher says that this is what these clinics have in common. Mosher stated that it should be flagged when a clinic claims that one type of stem cell can treat more than 20 diseases. These diseases span many systems, including neurological and urological. “So if they offer one type of stem cell (for example, taking the fat from someone’s love handles and making claims that it will treat ALS, COPD (chronic obstructive pulmonary disorder), it will treat autism, there is just no scientific support for such types of claims.” The Mississippi Stem Cell Treatment Center also uses stem cells taken from fat. Barmada stated that even though there is no scientific evidence to support his treatments, he believes they can heal. Mississippi Today reached out to them less than two hours later and they launched a new website. It now clarifies stem cell therapy as an “investigational” procedure and claims it “may promote healing and tissue generation.” Barmada stated that the website’s design and language were scheduled for an update within one week. These therapies aren’t FDA-approved but they aren’t illegal. They rely on an FDA loophole that allows them to treat patients with their own tissue as a surgical procedure, and not as drugs. This loophole may be closing. To be FDA compliant, the cells must be injected in the same area of the body where they were taken. Mosher stated that if the cells are taking fat from your body, they must use it as fat. The FDA sent a warning letter in December to Irvine Stem Cell Treatment Center. This was an affiliate of the Cell Surgical Network of which Gulf Coast Stem Cell also is a member. Incorrectly using adipose derived fat cells was one of the violations. This is the same method that Gulf Coast Stem Cell uses, as well as many other clinics within the Cell Surgical Networks. Gulf Coast Stem Cell also states that the treatments are funded by patients. Barmada stated that he uploads his results to clinicaltrials.gov which is managed by the National Institutes of Health. Although no results were found for his trials, a trial from Cell Surgical Network was listed. Mosher stressed, however, that the posting of data does not make a treatment a clinical trial. Mosher stated that there is no oversight or regulation in this space. Mosher said that clinics can claim to be registered with the (National Institutes of Health), but this is not proof of legitimacy. Mosher stated that there are legitimate clinical trials being conducted on the therapies offered at these clinics. However, it is difficult to see the website to tell which one is which. It’s difficult to determine how effective the treatments offered by these clinics. This is part of the problem of not having clinical data. Is this a one-off event? Is it a placebo effect? It’s difficult to say. It’s hard to tell.” Barmada agreed. Barmada argued that increasing FDA scrutiny would only benefit his business and similar stem-cell treatment centres. Barmada stated that people often misunderstand the feelings people have towards the FDA. “I believe that the FDA is there to protect me. “I don’t fear the FDA and I believe there is plenty of space for us to collaborate… and I think myself, my colleagues, are really happy to support the FDA.” Mosher understands the feelings of patients who will spend thousands of dollars for unproven therapies. Many of them believe that there is a chance of success, and they will spend thousands of dollars to get it. In many cases, they might be paying for treatments without solid scientific backing that they will work. 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