Pat Anson, Editor
Sara Bomar thought she’d be spending the rest of her life in a wheelchair or bedridden.
But the 54-year old Tennessee woman is not only walking again, she’s been able to resume her career as a doctor after an experimental stem cell treatment for her chronic back pain.
What makes her recovery all the more remarkable is that Bomar has arachnoiditis, a spinal disease that leaves many patients permanently disabled.
“I am able to walk. I am able to workout at the Y. I am still careful. It’s not like I don’t ever have any pain, I do have a little bit from time to time. But it is nothing compared to what I had before,” says Bomar, who practices general medicine in the Nashville area.
Bomar’s back problems started in 2000 with a ruptured disc. Surgery, physical therapy, epidural steroid injections and spinal cord stimulators all failed to stop the pain and her condition worsened. By 2008, she was in a wheelchair and diagnosed with arachnoiditis, an inflammation of the arachnoid membrane that surrounds the spinal cord.
The inflammation causes scar tissue to build around spinal nerves, which begin to adhere or stick together. That is known as adhesive arachnoiditis, which causes burning or stinging pain that can be felt from head to toe. The disease is progressive and thought to be incurable.
Or is it?
Two years ago Bomar heard about innovative stem cell treatments being offered by Todd Malan, MD, at the Center for Regenerative Cell Medicine in Scottsdale, Arizona. At the time, Malan had successfully treated only one other patient with arachnoiditis, but in that case the disease was still in its early stages. Bomar’s arachnoiditis was more advanced, but she thought stem cells were worth trying.
“It was kind of a shot in the dark,” she says. “There was really nothing else.”
Stem Cells as “Seeker Hunters”
Most people think stem cells can only be found in bone marrow or human embryos, but Malan uses fat-derived stem cells found in the patient’s adipose (fatty) tissue. When injected into the blood stream, Malan says these stem cells are “incredible seeker hunters” that can locate and repair damaged tissue, while reducing inflammation and improving circulation.
“The key is to understand that these stem cells are designed by the body to do this repair process,” Malan said. “What we’re trying to do with these procedures is to enhance the normal process that the body uses.”
Malan enhances the process further with a high-dose infusion of as many as 100 million stem cells. For patients with spinal cord or brain injuries, he also injects mannitol, a drug used to treat head trauma that apparently helps the stem cells pass through the blood-brain barrier into the central nervous system.
In August 2014, Bomar received a high-dose infusion of her own stem cells through an IV in her arm. Within a week, she noticed that the blood circulation in her left leg seemed to be improving.
“My mom came and visited me three days after I had the procedure and she said, ‘You know, I think your foot looks a little pinker.’ And I looked down and said, ‘Gosh mom, you’re right.’”
A few days later, Bomar noticed reduced swelling in her feet and could put on shoes that she wasn’t able to wear before. Months later, she was able to exercise on an underwater treadmill and then an elliptical machine. There was also less pain.
“The pain started to lessen. It was slow, it wasn’t all at once. But over months, which I think was fantastic progress, that pain did lessen,” she remembers. “Arachnoiditis is a pain that you deal with constantly. And it was really something not to have that constantly. I remember at first just thinking, wait a minute. I don’t have any pain right now. That was pretty amazing.”
Bomar’s condition has improved so much that she was able to vacation with her family in California last summer, and go hiking and bike riding.
Because Bomar still has metal in a spinal cord stimulator implanted in her back, an MRI can’t be taken to confirm if the nerves in her spine are still encased in scar tissue. But Malan is confident the scar tissue is either gone or the stem cells have created enough healthy nerve tissue to bypass the problem.
“The studies have been well documented, especially for scar tissue breakdown,” he says.
Malan has now treated about two dozen patients with arachnoiditis, but is careful not to say that a cure or treatment has been found. He says more studies are needed to confirm if his stem cell therapies are safe and effective.
“We have not had a patient yet who hasn’t had a clinical response,” he told Pain News Network. “The vast majority of the patients with adhesive arachnoiditis or chemical arachnoiditis have gotten to a point where they say their quality of life has significantly improved.”
“I believe the doctor. I think it could be a breakthrough,” says Forest Tennant, MD, a California pain physician who is one of the world’s leading experts on arachnoiditis.
Tennant plans to begin using stem cell treatments himself, along with other experimental therapies such as growth hormones. But he doesn’t think stem cells will work on patients with advanced cases of arachnoiditis.
“I do have two patients who have tried it and it did not work. But their cases were so far along. They were already bed-bound and paralyzed, and you can’t expect a treatment like that to help,” he said. “The disease has to be in its fairly early stages for it to work, would be my guess. We don’t know enough. It’s the old story of one case does not make a treatment, but one good case certainly stimulates investigation into that treatment. And that’s where we’re at with this.”
More Clinical Studies Needed
One issue that’s been holding up investigation is that most stem cell treatments have not been approved by the Food and Drug Administration. FDA commissioner Robert Califf, MD, was openly skeptical of stem cells derived from body fat (adipose tissue) in a commentary recently published in the New England Journal of Medicine.
“Stem cells derived from sources such as adipose tissue are being used to treat multiple orthopedic, neurologic, and other diseases. Often, these cells are being used in practice on the basis of minimal clinical evidence of safety or efficacy,” Califf wrote.
Dr. Malan bristles at the notion there is not enough evidence and blames the FDA for holding up stem cell research.
“The FDA hasn’t approved a single stem cell technology in 16 years in the United States,” he said. “These are approved therapies in other countries. And to make statements that there is inadequate evidence is ridiculous. The reason there is inadequate evidence is because the FDA has not permitted us to do anything but Phase I studies.”
Until more advanced studies are conducted and new stem cell therapies approved, the treatment that appears to have worked so well on Sara Bomar will not be widely available for patients who suffer from arachnoiditis. Dr. Tennant estimates as many as one million Americans may have the disease, many of them misdiagnosed with “failed back syndrome” or other spinal problems.
“It certainly helped me,” Bomar says of stem cell therapy. “As far as I’m aware, there is nothing else out there could provide this kind of relief.”