SAN DIEGO (KGTV) — UC San Diego Health is one of the first facilities in the nation using a new, experimental therapy to relieve epilepsy patients of their seizures, according to a press release from the medical center.
The procedure, which injects regenerative stem cells into the brain, is part of a national clinical trial with an end goal of eliminating seizures.
The press release says UCSD Health's multidisciplinary team performed the third-ever experimental regenerative brain cell therapy procedure earlier in July. The facility is the only Level 4 Adult Epilepsy Center, which is a national designation, in the San Diego area.
Dr. Sharona Ben-Haim conducted the complex procedure, injecting multiple interneurons into precise points mapped out on the patient's brain.
"If successful, the first-ever regenerative human cell experimental therapy, NRTX-1001, could provide drug-resistant temporal lobe epilepsy patients with the first non-destructive option to potentially cure their seizures," the press release says.
Dr. Ben-Haim has the credentials for the tall task: She is UCSD Health's surgical director of epilepsy and an associate professor of neurological surgery at UCSD School of Medicine.
“This experimental therapy offers us the potential to essentially restore the balance in the brain to be able to calm and ideally stop the seizures, while retaining the normal function of that part of the brain," she says. "Currently, we do not have a therapy that allows us to do that, so this is really exciting.”
The interneurons used in the procedure were derived from human stem cells.
Neurona Therapeutics is sponsoring the clinical trial, and it is looking for 40 participants from around the country to enroll in the trial. The group would study the results of the stem cells' implementation. The cells produce a neurotransmitter, called gamma-aminobutyric acid, to block overactive impulses between nerve cells in the brain, the press release says.
Dr. Jerry Shih, neurologist and director of UCSD Health's Epilepsy Center, explains epilepsy in the temporal lobe causes some of the normal brain cells in that region to become damaged or die. The disorder is drug-resistant in some cases, and that's what the clinical trial is attempting to rectify.
“This experimental cell therapy implants healthy human brain cells into the damaged temporal lobe with the hope that those new cells will begin establishing connections in the patient’s brain, to ultimately make a healthier temporal lobe,” Shih says.
According to the Centers for Disease Control and Prevention, epilepsy is the fourth most common neurological disorder in the country, behind migraines, strokes and Alzheimer's disease. Nearly 3.5 million Americans have epilepsy, and roughly a third of those people don't see positive results from anti-seizure medications, the press release says.
Typically, seizure reduction therapies included using lasers to burn parts of the brain where seizures start, or implanting electrodes deep into the brain to balance seizure activities.
Shih says this clinical trial is a sliding doors moment for epilepsy patients.
“This first-in-human clinical trial represents a paradigm shift in the way we treat this disease process, shifting from procedures that destroy bad tissue to procedures that repair the bad tissue,” Shih said. “Our hope is that this procedure has such a high success rate and good tolerability that it becomes the standard of care for all drug-resistant focal epilepsies.”
The other two times the experimental surgery was carried out both happened in 2022. The first time was at SUNY Upstate Medical University in Syracuse, New York, in June 2022. Following that, the Oregon Health Sciences University in Portland conducted it in Nov. 2022.
Ben-Haim says she has a deep respect for the patients going into uncharted waters.
“These patients are willing to try an experimental procedure in this clinical trial to get control of their seizures, and I think they are incredibly brave,” Ben-Haim said. “We are already seeing improvements in as early as one month. Our ultimate goal is to improve a patient’s long-term quality of life.”
Patients in the clinical trial will be monitored regularly for two years after the surgery, so researchers can observe the effects of the implanted stem cells. According to the press release, preliminary data reported in June shows seizure frequency dropped by 90% for the first two patients 19 months after their treatments.
Shih, who has more than 25 years of experience in the field, says this study is by far the most complex clinical trial he's been a part of.
“This study can only be conducted in an institution with a strong clinical and research infrastructure, which we are fortunate to have here at UC San Diego Health,” Shih says.
He gave credit to the faculty and staff in the following departments at UCSD and elsewhere for their involvement in the trial:
- Neurosciences
- Neurosurgery
- Cellular regenerative medicine
- Radiology
- Neuropsychology
- Neuro critical care
- California Institute for Regenerative Medicine Alpha Clinic at the Sanford Stem Cell Clinical Center
- Advanced Cell Therapy Lab
- Center for Multimodal Imaging and Genetics
- Consortium for Regenerative Medicine
“We would not have been able to participate in this study without the active collaboration of all these integral groups. It truly takes a village," Shih says.
You can read more about the clinical trial here.
