Using stem cells during brain surgery for epilepsy treatment

A Pilot Study to Evaluate the Feasibility and Safety of Allogenic Adipose-derived Mesenchymal Stem Cells(AMSCs) for Epilepsy During Deep Brain Stimulation(DBS) Surgery

This study is testing if using stem cells during brain surgery can help people with epilepsy who don’t respond to medication.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 5 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Mayo Clinic (Academic / other)
• Locations: 1 site (Jacksonville, Florida)
• Trial ID: NCT06280092 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the feasibility and safety of delivering adipose-derived mesenchymal stem cells (AMSCs) directly into the thalamus during deep brain stimulation (DBS) surgery for patients with drug-resistant epilepsy. Participants will undergo a standard preoperative evaluation, followed by a stereotactic procedure for the implantation of DBS leads, during which the stem cells will be infused. The study will monitor patients for up to a year post-therapy to assess any adverse events and the effects of the treatment through clinical and radiographic data.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with drug-resistant epilepsy who are undergoing bilateral DBS lead implantation.

Not a fit: Patients who do not have drug-resistant epilepsy or are not candidates for DBS surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel treatment option for patients with drug-resistant epilepsy, potentially improving seizure control.

How similar studies have performed: While the use of stem cells in neurological applications is an emerging field, this specific approach has not been extensively tested in prior studies, making it a novel investigation.

Eligibility criteria

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.

Where this trial is running

Jacksonville, Florida

• Mayo Clinic — Jacksonville, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Sanjeet Grewal, MD — Mayo Clinic
• Study coordinator: Megan J Gauthier, AS

Conditions Epilepsy