Can stem cells boost brain surgery for epilepsy?

NCT ID NCT06280092

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

Dec 2024

Finished

Sep 2026

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

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