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AMSCs for Epilepsy During Deep Brain Stimulation Surgery

This study is looking at the safety and effects of a treatment called Allogenic Adipose-derived Mesenchymal Stem Cells (AMSCs) for people with epilepsy that hasn't responded to other medicines. If you are between 18 and 75 years old, have drug-resistant epilepsy, and are already scheduled for deep brain stimulation (DBS) surgery, you might be able to join. During your DBS surgery, AMSCs will be directly infused into a specific part of your brain. Researchers will check for any side effects and look at MRI scans over 12 months to see how the treatment affects your brain. This study aims to see if this treatment is safe and how it affects the brain.

Study design
This is a non-randomized, open-label Phase 1 study involving 5 participants. It aims to evaluate the feasibility and safety of AMSCs delivered during DBS surgery.
What's involved
You will have a screening at an outpatient clinic, followed by a standard preoperative evaluation including lab tests and an MRI. The AMSCs will be infused during your DBS surgery.
Compensation
Not stated in the trial record.
Follow-up
Your safety and radiographic effects will be measured for 12 months after the treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06280092

Allogenic Adipose-derived Mesenchymal Stem Cells(AMSCs) for Epilepsy During Deep Brain Stimulation(DBS) Surgery

Recruiting
EARLY_PHASE1Ages 18–75Interventional
Sanjeet S. Grewal
~5 participants
Updated 2025-04-24 on ClinicalTrials.gov
What's tested:AMSCs

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of AEs related to the study agent
Measured over 12 months
+1 more outcome measured

Conditions

Epilepsy

Explore related trials

Seizure Disorder

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Sanjeet Grewal, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Megan J Gauthier, AS
[email protected]|
9049535544
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Incidence of AEs related to the study agent12 months

    To investigate the feasibility and safety of local delivery of AMSCs for epilepsy by measuring the incidence of AEs related to the study agent.

  • Radiographic effects related to the study agent12 months

    To investigate the effects of local delivery of AMSCs for epilepsy as measured by radiographic data on MRI.