A proposed class action lawsuit alleges the companies and individuals behind Giostar.com have fraudulently touted both the efficacy of using stem cells to treat a number of blood-related diseases and their own apparent qualifications and affiliations within the medical community.
The Orange County, California cancer survivor who filed the suit claims she paid more than $20,000 to defendants Global Institute of Stem Cell Therapy and Research USA, Giostar Labs, Bioscience Americas and four individuals based on the parties’ misrepresentations that stem cell treatment would be a “cure-all” for her Stage II Hodgkin lymphoma.
According to the 42-page lawsuit, however, the plaintiff, who was 29 when she was diagnosed with the treatable form of cancer, took a preventable turn for the worse after the defendants administered stem cell treatment without first requiring the woman to undergo chemotherapy or radiation to kill the cancer cells, or properly matching injected cells with cells in the plaintiff’s body. The plaintiff claims that following treatment with the defendants, her cancer progressed from Stage II to Stage IV within months, leading a medical expert to inform the woman “it was unlikely she would survive for more than a year.”
After receiving treatment in India from the defendants, who are not licensed to perform stem cell therapy in the U.S., the plaintiff was forced to endure surgery, blood transfusions and eight months of aggressive chemotherapy before entering remission, the case says.
The lawsuit alleges the defendants, who own, operate and are responsible for the content on Giostar.com, have misrepresented that stem cell therapy can treat and cure diseases, including sickle cell anemia, leukemia, lymphoma and thalassemia. Further, the defendants have misrepresented the process by which patients will receive stem cell treatment, as well as the “reach and breadth” of the institution by claiming they have advanced treatment and research centers that, in truth, they do not have, the lawsuit says.
In addition, the suit claims the parties have misrepresented the purported medical and research affiliations, overall qualifications and educational background of one of the individual defendants, a co-founder of Giostar. What’s more, three prominent scientists listed by the defendants as Giostar board members claim they have no connection with the company, and have repeatedly asked that their names be removed from its website, the case says.
Stems cell transplants are generally ineffective at directly treating cancer and may instead be used to restore blood-forming cells in those whose cells have been destroyed by high doses of chemotherapy or radiation therapy, the suit says. Given chemotherapy and radiation therapy kill both cancer and stem cells in bone marrow, it is only after such treatment is complete that stem cells should be introduced to a patient in order to replace those that were destroyed, according to the case.
“The administration of stem cells by Defendants to treat diseases such as cancer, without first destroying the disease causing cells by chemotherapy or radiation, is exceptionally dangerous and risks patient health and life,” the case reads.
The lawsuit adds that replacement stem cells from a donor must match those of a recipient or the donor cells may attack a patient’s healthy cells, leading to possible organ damage.
Per the complaint, the FDA has issued multiple advisories with regard to the safety of stem cell therapies, warning that the agency is concerned patients seeking cures and remedies may be vulnerable to illegal and potentially harmful treatments. The suit says the FDA has warned against clinics inappropriately advertising stem cell clinical trials without submitting an Investigational New Drug Application, and suggesting to patients that FDA review and approval of stem cell therapy is unnecessary.
The plaintiff claims she relied on the defendants’ representations in deciding to undergo stem cell therapy almost a year after her diagnosis while she was pain- and symptom-free. According to the case, the woman paid $22,500 for the defendants’ treatment plan, which included three stem cell transplants, two hotel stays in India, food and transportation to and from the airport.
"To this day, Plaintiff continues to be medically monitored for a resurgence of the cancer and continues to undergo medical procedures to try to prevent its return," the suit says.
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