Can stem cells boost brain surgery for epilepsy?
NCT ID NCT06280092
First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time
Summary
This early study tests whether delivering stem cells directly into the brain during deep brain stimulation (DBS) surgery is safe and feasible for people with drug-resistant epilepsy. One adult participant will receive a single dose of stem cells in the thalamus, a brain region involved in seizures, right before the DBS leads are placed. Researchers will monitor for side effects and check MRI scans over a year to see how the brain responds.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Allogeneic adipose-derived mesenchymal stem cells (AMSCs) delivered into the brain during deep brain stimulation surgery
- What this could lead to
- If safe, this approach could combine stem cell therapy with deep brain stimulation to better control seizures in people with drug-resistant epilepsy.
- What could go wrong
- This is an early, very small pilot study (one participant), so it mainly tests safety and feasibility, not effectiveness. Risks include surgical complications and immune reactions to the cells.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
1 person
The number who actually took part.
- Started
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Dec 2024
- Finished
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Sep 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants ≥ 18 years of age. * Participants with Drug Resistance Epilepsy as defined by the ILAE5. * Participants undergoing bilateral implantation of DBS leads into the anterior nucleus of the thalamus. * Adequate organ function as assessed by the following laboratory values within 3 weeks prior to admission to the study: * Serum creatinine and urea \< 2 times the upper limit of normal; * ALT, AST and alkaline phosphatase \< 3 times the upper limit of normal, and bilirubin \< 2.5 mg/dL; * Prothrombin time ≤ 1.5 times upper limit of normal; * INR and PTT ≤ 1.5 times the upper limit of normal; * Hemoglobin ≥ 9 g/dL; * Platelets ≥ 100 x 10\^9/L; * Absolute Neutrophil Count (ANC) ≥ 1.5 x 10\^9/L. * Patient or legal guardian is able to fully understand and provide written and verbal consent for the protocol. * Patient is a candidate for ANT DBS based on the following criteria established by the American Society for Stereotactic and Functional Neurosurgeons: * Confirmed diagnosis of epilepsy by an epileptologist with focal-onset seizures, with or without generalization; * Failure to adequately control seizures after two (or more) appropriate and adequately-dosed anti-seizure medications; * Either partial-onset seizures with a localized onset in a region not amenable to resection or following failed resective surgery or focal-onset seizures with distributed or unclear onset zone. Exclusion Criteria: * Patients who have undergone a prior intracranial procedure for epilepsy. * Patients with an intracranial tumor. * Confirmed pregnancy. * History of cancer not in remission for at least 5 years. * History of diabetes, chronic renal failure, or other significant underlying medical or ----immunosuppressive conditions. * History of drug or alcohol abuse. * Subjects allergic to any component of the investigational product. * Subjects \> 75 years of age. * Cognitively impaired adults.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Mayo Clinic
Jacksonville, Florida, 32224, United States
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