ATLANTA (FOX 5 Atlanta) - The Centers for Disease Control and Prevention in Atlanta issued a nationwide call for reports of any patients who were infected by contaminated off-the-shelf stem cell products.
To date, the CDC has identified at least 13 patients who were hospitalized by bacterial infections after receiving stem cell cord blood treatments.
FOX 5 Senior I-Team Reporter Dale Russell has been investigating umbilical cord blood stem cell products for weeks now and traveled across the country to find out what happened.
The CDC reported in December that patients in three states got sick, some hospitalized for a month or more. We set out to find out what the patients went through.
On a cool winter morning, as the sun rises over Houston Texas, Dr. Sammy Tao arrives at his Chiropractic clinic. The FOX 5 I-Team was waiting for him.
We wanted to ask him about a lawsuit. What lawsuit? Who is Dr. Tao? And, why were we in Houston?
The FOX 5 I-Team has been investigating the marketing and sale of various off-the-shelf products sold to patients claiming to contain live stem cells.
Doctors and chiropractors market these cryogenically frozen fluids from a donor mother's umbilical cord. They inject the fluid into a patient's, back, knees, joints...promising to rejuvenate cells and eliminate pain.
But there is one 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,” said Dr.Powell
The CDC in Atlanta recently reported at least 12 patients in 3 states were hospitalized because of an infection from a contaminated umbilical cord stem cell product. There were no reported cases in Georgia. So, we traveled to Texas to find out what happened and why.
Three of those patients have sued Houston chiropractor Dr. Tao and his clinic for "negligently" injecting them with a stem cell product that was "contaminated."
In the lawsuit, Dr. Tao and the clinic "deny" the allegations and argue any damages were caused by "the acts" of other "parties."
Here is what happened. Late last year, state health departments in Texas and Florida, discovered patients were getting sick after getting injections from doctors or chiropractors using an umbilical cord blood-derived product manufactured in California and distributed by Liveyon.
In this press release, Liveyon announced a voluntary recall "due to reported possible adverse reactions" and immediately stopped buying the California product they sold. In response to the patient's lawsuit, Liveyon "deny" any wrongdoing.
So, when the CDC learned patients were hospitalized they put out a nationwide call for any more victims. The CDC identified as of now - 13 patients who got sick after getting a stem cell injection.
“Luckily, no patients died. But all of the patients required hospitalization and some hospitalizations were quite lengthy///but half of the patients required hospitalization for at least two weeks. And one patient even required hospitalization for two months,” said Dr. Howell.
Dorothy O'Connell was one of those patients. We met her and her daughter in Houston. She says she had severe back pain. She turned to Dr. Tao's clinic for help, including stem cell injections. Following one set of injections, she got violently sick. Court records indicate she had "acute renal (kidney) failure" She was flown by helicopter to a hospital for more acute care.
Dorothy doesn't remember what happened next. Her daughter does.
“I thought at one time we were going to lose her. I was horrified because I couldn't understand what was going on. Because she just had stem cells,” said Elaine Dilley.
Court records show Dorothy O’Connell was hospitalized for "13 days" followed by "five weeks" in a rehabilitation hospital. She requires round the clock care at home. Her lawsuit claims the so-called stem cell injection was contaminated with bacteria.
“When you're you know, you're watching your mother, that one day she's fine. The only that's wrong with her as arthritis. And then the next day she's fixing to die,” said Ms. Dilley.
The CDC's initial investigation suggested the contamination occurred during the manufacturing process. The FDA inspected and then warned the California manufacturer, Genetech, about marketing stem cell products without FDA approval. The FDA also sent letters to other manufacturers and health care providers reminding them of FDA's rules on use of stem cell products.