Are You Aware of the Hidden Risks from Stem Cell Treatments?

Stem cells are biological cells found in all multicellular organisms. Stem cells can be taken from umbilical cord blood just after birth. Autologous cells are obtained from one’s own body, just as one may bank his or her own blood for elective surgical procedures.

Dr. Jim Guest presented a talk at the World Stem Cell Summit this month.  He mentioned that if you receive a stem cell transplant, even the doctor injecting you doesn’t know for sure what’s coming through that syringe into your body.  He said that another underappreciated risk is not from the stem cells themselves, but rather from the procedure itself. He presented a stem cell treatment case in which the cells caused undesired tissue growth (angiogenesis), causing the patient to lose that kidney.

A second speaker, Dr. Allan Wu, a plastic surgeon with California’s Morrow Institute, advised patients to ask one important question when evaluating clinics and doctors for stem cell treatment. He said to ask, “If I have a complication will you be able to directly take care of me?”  He believes most stem cell clinics would be unable to honestly answer ‘yes’.”  Dr. Wu also pointed out that autologous doesn’t mean a stem cell treatment is safe and doesn’t mean it won’t cause a life-threatening autoimmune reaction.

Other risks to be aware of include lack of properly functioning autoclaves, putting patients at risk of infection, including life-threatening sepsis. If the instruments are not thoroughly sterilized, infection from pathogens becomes a risk, as well as cross-contamination with other patients’ cells.

Parents of a nine-year-old boy from Boca Raton, Florida traveled to Mexico for stem cell injections to help their son’s cerebral palsy. They discontinued the treatments in 2005 after spending $25,000 and seeing no improvement. They feel so fortunate that the treatments did not harm their son.

With promising breakthroughs in the news, as well as Internet hype, seriously ill patients, as well as desperate parents, may look to stem cell therapy as the modern miracle that could cure them or their loved ones. And perhaps one day, stem cells may routinely be used to repair damaged cells, improve the treatment of diseases and even cure paralysis.

However, there are hidden dangers to today’s stem cell treatments, both in the U.S. and offshore, scientists said at the World Stem Cell Summit in West Palm Beach. They pointed to reports of deaths, tumors, lumbar punctures and other potential harm, as well as vulnerable people being conned out of thousands of dollars.

Patients are “buying hope,” said University of Miami scientist James Guest, working on the Miami Project to Cure Paralysis. He and other scientists say that it takes many years to complete research.  Scientists urge consumers to look for regulated clinical trials at universities and research institutions, saying that even those are not without risks.

“Clinics are operating out of loopholes, a gray area disguised as the practice of medicine,” said George Q. Daley, director of the stem cell transplantation program at HHMI/Children’s Hospital in Boston.

Douglas Sipp, industry researcher, has kept records of more than 400 companies advertising stem cell procedures on websites since 2007. When he rechecked this summer, Sipp said 80 of the sites were no longer online, though they could have simply changed web addresses.

Many offshore clinics have been closed after patients died, according to Sipp, who leads the research unit for Science Policy and Ethics Studies at the RIKEN Center in Japan.

Dr. Wu says that consumers can be fooled by clinics using medical ‘buzz’ words like “autologous.” Some clinics claim on their websites that they are FDA-approved, which is untrue.

The FDA has only approved cord-blood stem cell products, being used in studies of leukemia, bone marrow disease and other blood disorders; no therapies have been approved.

State health regulators suspended the medical license of Bonita Springs, Florida cardiologist Zannos Grekos after his 69-year-old patient died in 2010. The patient was being treated for numbness in her feet. The state’s lawsuit contends that the patient’s medical records did not justify Dr. Grekos’ infusion of stem cells from bone marrow into the blood flow in the brain.  A judgment in the trial is expected in February.

In Boca Raton, Florida, an orthopedic specialist said he is making strides using stem cells in repairing the knee.

“Run from anybody who says they’re going to ‘cure’ your condition,” said Dr. Joesph Purita, who has been doing the experimental stem cell treatments for seven years. Although he has treated “dozens” of athletes with stem cell treatments, “we haven’t cured arthritis; we’ve found a way to make it better,” said Dr. Purita.

Would you trust a doctor to perform a treatment on you that has not been approved by the FDA? Feel free to comment on this blog post. Contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).

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