Stem Cell Treatments: 6 False-Hope Warning Signs
Unproven, Risky Treatments Mislead Patients to Seek Cutting-Edge Therapy
No Results, No Regrets continued...
In Tijuana, Gusty got heavy metal
, growth hormone shots, drugs to stimulate the production of
. Bone marrow drained from her leg was injected directly into her spine, into her muscle, and infused into her bloodstream.
After her first visit, she felt more energetic, although she was disappointed that her condition didn't improve much. After the second treatment, she says she felt "a slight improvement, and then I settled into the same condition I had been in."
Still, she sees a different kind of value in it. "I learned so much," she says. "It changed my direction and put me on the path I am on now. I am not seeing a traditional neurologist, and not taking standard medicine."
6 Warning Signs
The International Society for Stem Cell Research (ISSCR), a group of established stem cell researchers concerned with the proliferation of unproven treatments, has issued a patient handbook on stem cell therapies.
The ISSCR advises patients to seek only stem cell treatments being tested in clinical trials approved by the FDA (or, if abroad, by a national regulatory agency such as the European Medicines Agency). It also allows for smaller studies approved by an independent Institutional Review Board (IRB) or Ethics Review Board (ERB).
The ISSCR lists these warning signs that a stem cell treatment is not legitimate:
It makes claims based on patient testimonials.
The same stem cells are used to treat multiple diseases.
The source of the stem cells is not clearly documented.
How the treatment will be done is not clearly documented in a "protocol" that serves as the medical practitioner's operating manual for the procedure.
Claims there is no risk. All medical procedures carry some risk.
High cost or hidden costs. Legitimate clinical trials don't charge patients. Some even pay them to participate.
Anyone still considering a therapy after checking all of the above can
download the 26-item list of questions
the ISSCR recommends asking. Ask a doctor or medical professional to help you understand the answers to these questions about the treatment, scientific evidence behind it, oversight of the clinic and practitioner, safety and emergency plans, patient rights, and costs.
"One of the notorious signs of an unproven therapy is the claim it will treat anything," Levine says. "A lot of people say we have stem cells that will seek out your ailments and cure them, whatever they are, anything from spinal cord injury to
. It is hard to imagine how a single therapy could really be beneficial for all of these things."
Stem Cell Treatments and the FDA
In the U.S., the FDA says "stem cells, like other medical products that are intended to treat, cure, or prevent disease, generally require FDA approval before they can be marketed."