Cutting edge stem cell therapy is being touted as a possible cure for everything from spinal cord injuries to Parkinson's and Alzheimer's.
But it's largely unregulated here in the U.S. Boston 25 News looked into the burgeoning business.
WHAT ARE STEM CELLS?
Stem cells are special human cells that have the ability to develop into many different cell types, from muscle cells to brain cells. In some cases, they also have the ability to repair damaged tissues.
Stem cells used for stem cell therapy can come from different sources like cord blood or placenta tissue.
They can be injected everywhere from your brain to your sore knee.
STEM CELL THERAPY FOR AUTISM
Marty Kelley of Bangor, Maine tells Boston 25 News her son, Ken, is able to talk to her today because of stem cell therapy.
"Our first treatment was such a miracle," said Kelley. "He immediately started talking to us. He talked about the past for the very first time. This was a child who couldn't answer who, what, when, where why questions."
Ken was diagnosed with autism at Boston Children's Hospital when he was 2. His mother says by the time he was 8, he still couldn't fully communicate. The Kelleys traveled from Bangor to Panama where Ken received stem cells from umbilical cord tissue.
"Within 9 months, he was completely reading. He picked up a book and was able to read," said Kelley.
Ken has now been to Panama 8 times for stem cell therapy. Each time, his mother says she sees progress.
HAPPENING IN MASSACHUSETTS: STEM CELL THERAPY FOR JOINTS
You don't have to go overseas anymore to find clinics offering stem cell therapy. There are hundreds of clinics that have popped up here in the U.S., including a handful right here in Massachusetts.
At Maragal Medical in Leominster, Dr. Timothy Gallagher, a chiropractor, is using stem cells from placenta tissue to treat joint problems for painful conditions like Arthritis. Injections can cost anywhere from $4,500 to $10,000. Dr. Gallagher says many patients experience the quality of life improvements. For example, he says a patient who couldn't take his or her dog for a walk may now be able to do that. He says they've seen a 90% patient satisfaction rate with his patients.
ONE SOLUTION TO THE OPIOID CRISIS?
And Dr. Gallagher believes it's safe. He even sees stem cell therapy a potential way to help counter the opioid crisis, because it's a drug-free way to treat pain.
But he's also upfront that stem cells don't work for everyone.
"And we're very clear with patients," said Gallagher. "For 4% of the population it's just not going to work and we don't know why. There's never ever been a reported adverse side effect from an amniotic allograft injection, ever."
"So far we're at an over 90% patient satisfaction rate. And we're very clear with patients. For 4% of the population, it's just not going to work - we don't know why."
STEM CELL TREATMENTS GONE WRONG
Stem cell therapy did not work for Doris Tyler. Instead, she says it left her completely blind. Tyler received the treatment for her macular degeneration.
Her Doctor in Georgia injected stem cells from her own body fat into her eye.
She later found out she was the clinic's first macular patient.
"It hurts because I trusted in them. This was gonna be the most wonderful thing that ever happened to me," said Tyler.
Brigham and Women's Neurosurgeon Dr. John Chi has been vocal about those types of bad outcomes from stem cell therapy, after one of his patients traveled around the world for injections, to try to treat his partial paralysis. His patient received stem cells from fetal tissue he bought in Russia and then was injected with it in clinics in Argentina, China, and Mexico. When the patient wound up in pain in Dr. Chi's office, Dr. Chi discovered a growth on the patient's spine where some of the stem cells had been injected. He became fully paralyzed.
"Many, if not all of these of these small local clinics are just providing treatments without really the backing for it," said Dr. John Chi.
Dr. Chi says treatment needs to be tested and regulated.
WHERE DOES THE FDA STAND ON STEM CELLS?
So far stem cells have been a gray area for the Food and Drug Administration.
The FDA told Boston 25 News, the only stem cell-based products that are FDA-approved are derived from cord blood and only for a small number of conditions, including leukemia and immune system disorders.
But we found several local companies making FDA-approved stem cell products including:
- "Vericel" in Cambridge for knee repair
- "Organogenesis" in Canton for dental applications
- "Biovex" in Woburn for melanoma tumors.
THE BOTTOM LINE
For patients looking for a miracle cure, Dr. Chi recommends taking a closer look at the fine print.
"Most of these other clinics will have a disclaimer somewhere in the paperwork or in their office that says that they are not purporting that any of the benefits that they have otherwise marketed are actually scientifically proven," said Dr. Chi.
The FDA recently issued a letter to rogue stem-cell clinics and manufacturers warning them to stop selling unproven treatments.
But it stopped short of threatening legal action.
And some other guidelines for people considering stem cell therapy: Dr. Gallagher recommends making sure the clinic offering it is approved by the state through the Mass Medical Board. He also says ask for proof that the clinic gets its stem cells from a lab that is registered by the FDA. And ask about the clinic's training and protocols.
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