Emory one-of-a-kind stem cell study underway
ATLANTA (FOX 5 Atlanta) - For months, the FOX 5 I-Team has raised questions about some over the counter stem cell products marketed as medical magic and sold at high prices to sick patients.
Now, major changes are underway in an industry that has cropped up across the country.
Emory Medical School is launching a one of a kind stem cell study that could help guide patients in the future to the best stem cell option. And, the State Attorney General has opened its first-ever investigation into one local stem cell medical clinic.
With all the questions surrounding the promising and at times the troubling world of stem cell therapy, Emory Orthopedics & Spine Center hopes to find some answers.
Emory sports medicine physician, Dr. Ken Mautner says Emory and other orthopedic departments, plan a one of a kind two-year study of 500 patients, researching three different stem cell therapies to treat osteoarthritis in the knees.
“This is probably the largest stem cell study ever been done,” says Dr. Mautner.
The approved Emory study comes at a critical time in the stem cell industry. There has been an explosion of stem cell clinics across the country with doctors and chiropractors marketing cryogenically frozen fluids from a donor mother's umbilical cord that are supposed to contain live stem cells. They inject the fluid into a patient's, back, knees, joints - promising to rejuvenate cells and eliminate pain.
But there is one major problem: CDC Doctor Krista Powell says those umbilical cord blood products are not approved for these types of injections.
“What we're talking about are products that are illegally marketed so products that are not, they don't have FDA approval. They are unapproved and unproven,” says Dr. Powell.
In Texas, three patients filed a lawsuit against a manufacturer, distributor, clinic and two doctors claiming they got a contaminated stem cell product that not only made them violently ill but it "contained no living cells" and therefore no "stem cells.” The defendants deny any wrongdoing.
“I think it's selling them something with a bunch of smoke and mirrors,” said attorney Hartley Hampton.
Closer to home, the I-Team attended a free seminar where Superior Healthcare Group vowed their live stem cell injections can help reverse osteoarthritis, some heart and lung disease, sometimes even Parkinson's and cancer.
After attending a similar Superior Healthcare Group Seminar, Cheryl Armstrong signed up for multiple treatments for back, knee, and hip pain.
“I think they're relying on the hoopla they do at the seminars. They get people who are desperately hurting and in pain. And, they're looking for hope to fix it,” said Armstrong.
She signed a "Human Amniotic Fluid" consent form to allow the clinic "to perform stem cell injections."
After the first injections, she complained to the FDA that she suffered from "massive burning and tingling in my hands" and canceled her next scheduled treatment.
In a letter to Superior Healthcare, Chery's attorney demanded her money back calling the clinic's amniotic "purported 'stem cell' injection program is a total sham."
“They're taking advantage of people that they're hurting people and they're lining their pockets full of money,” said Armstrong.
Superior Healthcare wrote back stating Cheryl received injections of "amniotic cellular tissue" and "platelet-rich plasma" and was scheduled later to get a stem cell treatment using her own bone marrow.
The clinic doctor wrote that he was "sorry to hear that she is still in pain" however "not receiving the second phase of therapy certainly can affect outcomes." They refunded her money.
Cheryl Armstrong also filed a complaint against Superior Healthcare with the Attorney General's office. We asked for a copy of the complaint. The AG said, by law, they could not release the complaint, writing, "our investigation of this entity is currently pending."
Emory University Medical ethicist Dr. Paul Root Wolpe fears regulators like a state attorney general or the Food and Drug Administration cannot keep up with an exploding industry that makes so much money selling hope to so many people.
“People have been harmed, significantly harmed by bogus stem cell treatments,” says Root Wolpe.
He wants federal regulators to do more to protect patients from what the FDA has already called bad actors in the stem cell industry.
“It’s very disturbing when any profession plays on its public trust to mislead people. I think it is the worst kind of betrayal,” says Root Wolpe.
Now, Emory hopes to discover whether stem cell treatments work on osteoarthritis. Which treatment works best?
They plan to compare umbilical cord stem cell treatments, with stem cells taken from a patient's own body - either bone marrow or fat tissue. The answer, at least for arthritis in the knees, perhaps one study away.
“We're trying to do the right thing. We are trying to move the field forward as well as help patients feel better, versus these companies who are most likely trying to make large profits and are making completely false claims without any evidence behind them,” said Dr. Mautner.