SIDNEY — Some people won’t take, “No,” for an answer.
They’re the ones who stubbornly persist when early trials fail, who refuse to give up when things don’t go their way, who find ways around, over or through obstacles that land in their paths.
Connie Kerns is one of them.
For the last 24 years, Kerns, of Sidney, has held out hope that a therapy would be developed that could help her daughter, Alyssa Elliston, also of Sidney, and she will stop at nothing to get that help. She has defied doctors, specialists, family members and caregivers.
In late November 1993, then 17-year-old Elliston was in a car accident in Kentucky. The car in which she was riding went over a cliff, and she sustained severe traumatic brain injury, TBI. She has not recovered — yet. Confined to a wheelchair and able to speak only with difficulty, Elliston has been living in a group home in Sidney since 1998. Before that, “home” was a series of hospitals and nursing facilities.
Recently, Kerns learned of an experimental treatment available at TBI Therapy, a clinic in Colorado that uses stem cells from a patient’s blood to regenerate brain cells lost due to TBI. She has planned a fundraiser, May 5, at the Shelby County Fairgrounds to help in the effort to collect $48,000 to cover travel, treatment and rehabilitation costs.
Titled a Celebration of Hope and presented under the auspices of Alyssa’s Breath, a nonprofit organization Kerns founded to raise money and TBI awareness, the event will run from 11 a.m. to midnight and include a golf ball-drop from a hot air balloon at 3 p.m., a band marathon at 5 p.m. and vendor booths, food trucks, a poker run, a cruise-in with music by Janie & Company, a dunk tank, children’s games, face painting and a beer and wine garden throughout the day.
Sports Car Club of America racer and TBI survivor and advocate John Mills will speak at 1 p.m. at the gazebo on the fairgrounds.
Admission is free. Golf balls can be purchased for $10 or three for $25.
Once Kerns has raised the funds needed for Elliston’s Colorado sojourn, Alyssa’s Breath will make grants to other TBI victims.
In Colorado, Elliston will undergo a 10-day protocol involving intranasal adult stem cells, intranasal platelet rich plasma, hyperaric oxygen therapy, intravenous nutrition, cranial osteopathy and a ketogenic diet at the clinic in Aspen, TBI Therapy, run by Dr. John C. Hughes. Kerns then plans to find rehabilitation therapy for her daughter.
Kerns hopes results will be better than the physical and occupational therapy Elliston had in the first seven years following the accident.
“They want to see improvement. If they don’t see improvement, they say nothing is going to happen, so doctors decide to stop it,” Kerns said. Kerns has since worked with Elliston on range-of motion exercises.
“We do a lot of work on her neck and heat and vibrator on her back. Once a week, (we add) an ionic foot detox. Alyssa has encouraged me a lot to look at alternative methods for healing. Medicine stops the pain but doesn’t heal,” Kerns said.
About 10 years ago, she began to see information online about stem cell treatments.
“I called Ohio State University, the Mayo Clinic, University of Kentucky about stem cells. They do (treatments) but not for head trauma. They didn’t know where to direct me,” Kerns said.
Her further Internet search took her to the TBI Therapy website. An article in the March 2018 issue of Consumer Reports warns that many clinics nationwide have begun to market stem cell treatments for a variety of conditions, treatments that have not been scientifically proven. Some such treatments, it warns, are not only ineffective, but dangerous. TBI Therapy is not among the clinics cited in the article.
Treatments at Hughes’s clinic are not covered by insurance. There have been no clinical trials of his specific combination of therapies. He has put together parts of several kinds of therapies to develop his own protocols, which he has patented.
A patent, however, does not guarantee that a treatment is safe or effective.
“Within the patent laws, the examiner assigned to examination of a patent application directed to a medical protocol would ensure that the claimed invention was adequately described such that one could make and use the claimed invention, and that the invention was novel and non-obvious,” the U.S. Patent Office wrote in answer to a Sidney Daily News inquiry. “Furthermore, the patent law requires that an invention have utility, which, for a medical protocol, can be shown with evidence in the patent application, such as in vitro test data or animal model data. The examiner’s role in evaluating this evidence is to ensure compliance with the patent law, not to ensure that the invention as claimed is safe and effective for a particular patient population. Compliance with the utility requirement of the patent laws is not equivalent to a safety and efficacy analysis. Whether a medical protocol that is claimed in a patent is safe and effective for a particular patient population is solely within the purview of the Food and Drug Administration.”
“We’re still learning the process,” Hughes told the Sidney Daily News in February. “It’s still a new science. It’s outside the box.”
He said he works, however, according to Food and Drug Administration guidelines.
“There’s enough research to make it valid,” Hughes said. His method calls for a series of steps: hyperbaric oxygen therapy, during which a patient breathes 100 percent oxygen at increased levels of atmospheric pressure; then harvesting a patient’s blood for platelet-rich plasma, combining it with insulin and injecting it into the patient’s brain through his nose.
The third step involves harvesting a patient’s blood for stem cells that are also injected into the brain through the nose. This is followed by intravenous feeding of vitamins and nutrients to act as stem cell supplements. Then comes cranial osteopathy, the manual manipulation of cranial bones and membranes.
Ongoing adherence to a ketogenic diet, one high in fat and proteins and low in carbohydrates, and the use of supplements including blueberries and elk horn is the last step in the procedure.
Hughes has based his therapy mostly on intranasal research on Alzheimer’s disease patients.
“I’ve taken it to the next level and use stem cells, which are very regenerative,” he said. “We’ve combined some research on the hyberbaric and ketogenic diets, as well as functional nutrition, in one protocol. We’ve had such great results, people started calling from everywhere.”
Hope for change
Hughes noted that his clinic treats about four patients per month and that most see metabolic improvement: more energy or better sleep.
“I believe (the treatments) will change (Elliston’s) life,” her mother said, “that she will be able to get out of the wheelchair and function more on her own.”
None of Hughes’s patients has been as far removed in time from the original trauma as has Elliston.
“Most patients have suffered within the last 10 years,” he said.
On his website, www.tbitherapy.com, Hughes lists references to extensive research concerning hyperbaric oxygen therapy and stem cell investigations. He specifically includes links to papers by Dr. Dong Sun, associate professor in the Department of Anatomy and Neurobiology of the School of Medicine at Virginia Commonwealth University, and by Dr. Charles S. Cox Jr., George and Cynthia Mitchell Distinguished Chair in Neuroscience and professor of pediatric surgery at the McGovern Medical School at the University of Texas Health in Houston, Texas.
Sun’s work, however, has been solely on animals.
“A beneficial effect is shown in pre-clinical studies with animal models,” she said, noting that little research has been done on injuries as old as 24 years. “Trauma patients so far along — we really don’t know because there are no trials. Unfortunately for now, there is no treatment for something so far away.”
She said hyperbaric treatment is more useful in earlier stages of a patient’s treatment.
“The best (protocol) is still physical therapy to improve patient recovery,” Sun said.
Cox has conducted one clinical trial of stem cell therapy on TBI patients, but none of them was more than 48 hours past the injury.
“All my current protocols are in the acute phase, the first 48 hours post injury, something that’s really focused in this very, very early period of time, where it’s supposed (to influence TBI),” he said. “We don’t have any current evidence of any chronic therapeutic approach.”
His research also used intravenous rather than intranasal cell-based therapies.
“(Hughes’s protocol) doesn’t really have anything that’s related to our work,” Cox said. “There isn’t much out there that works,” he added.
Hughes acknowledged that “the more recent the injury, the more curable it is. A patient 23 years later may need treatment two or three times a year. I don’t expect more than 30 percent improvement after four months — less sensitivity to sound or light or better sleep. It’s baby steps, an exponential increase. It’s still a new science.”
Kerns isn’t sure what will follow the TBI Therapy treatment of Elliston. She has looked into and rejected a questionable rehab clinic in Denver.
“But Alyssa will need extensive rehab somewhere,” Kerns said.
In addition to the fundraising event, Kerns has opened a GoFundMe account: www.gofundme.com/alyssas-journey-for-stem-cell.
“This is about hope for a group of individuals who can’t voice their needs. We want to bring awareness. We want to be a voice. (Alyssa’s) not going to be the only one we’re doing this for,” Kerns said.
Reach the writer at 937-538-4824.