SAN ANTONIO – The stem cell therapy a San Antonio mother says is saving her life has been deemed illegal. Now, she and thousands of others across the nation are fighting to change that.
Stefanie Cowley rolled in her wheelchair as her 6-year-old son Tyler skipped beside her on the sidewalk, and she breathed it all in. She takes nothing for granted.
"Getting our vitamin D!" she laughed. "Sunshine!"
She was diagnosed with multiple sclerosis in 2007, and things went downhill quickly. MS is a disease in which the immune system eats away at the protective covering of nerves. It can cause vision loss, pain, fatigue and impaired coordination.
Two years ago, Cowley was bedridden and almost completely immobile.
"I was at rock bottom. I would rather not wake up the next day," Cowley said.
For the five years after her diagnosis, she tried about six conventional and approved therapies, but none worked. She was only getting worse.
"At that point, I felt I was out of options. I was spending more time in bed. I had already quit work. I was going through the disability process," she said.
She started looking for alternative therapies and found a stem cell procedure done by a company called Celltex. The therapy takes mesenchymal stem cells out of patients, lets the cells grow and expand, then re-injects them into the patient.
"Those are your healing cells. If you get cut, those are the cells that repair the cut. It's what helps your system repair itself," Cowley said.
In 2012, the treatment went public. The first patient Celltex used the treatment on was Gov. Rick Perry, who had terrible back problems.
"The FDA was on it right away and shut them down," Cowley said.
The FDA made it illegal to re-inject stem cells that have been removed from the body and manipulated. They say after 24 hours, the expanded cells are considered a drug.
Cowley said she believes it's all about money.
"The FDA came in and said, since once your cells are manipulated they become a drug, they have to go through the clinical trial process. Then you go up against the drug companies. [The drug companies] want to patent it and make the money on it," she said.
Cowley has stem cells sitting in Houston, but to get them injected, she has to go to a special hospital in Cancun, Mexico.
"The doctors at that hospital are exceptional, top of the line. They are amazing, but the cost and distance is a barrier," she said.
She's had two re-injection treatments at the hospital in Mexico over the last two years. She calls the procedure a miracle.
"It's really given me range of motion back. I couldn't raise my arms at all. I was having trouble with my hands. I couldn't write," she said.
Within days, her pain level was cut in half.
"Before the treatment, my pain had been at an 8 or 9 out of 10 for almost five years. Now it's at a 3 or 4. It felt like a tingling burning sensation but with electrical currents running through it. That's what I lived with for five years, and I felt that just melt away with that treatment," Cowley said.
She is still wheelchair-bound, but can sit up, write, hold her phone and hold her son. She goes to his sports and school events and gets to interact with other parents. She has her life back.
After seeing vast improvements, she quickly joined the fight to make the therapy legal.
"It was started by Sen. Mark Kirk in Illinois and Sen. Susan Collins in Maine. It's a grassroots effort and they've been working for four years on this legislation," Cowley said.
It's called the Regrow Act, and it is about to be posted to the public. It will then head to Capitol Hill for assessment and eventually a vote. If it passes, it will most likely be bundled into the 21st Century Cure Act and become law. It's a process Cowley feels like her health is riding on.
"These are our cells. And it should be treated like a blood transfusion. Blood doesn't go through all these clinical trials," she said.
Looking at her son, she hopes the therapy will be legal soon. She explained the therapy is not just used for MS patients, but patients with other crippling diseases, too, like ALS. She is asking for public support once the Regrow Act is released.
Wednesday night, Sen. Kirk released an official release about the Regrow Act. Click here to read it.