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

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 anteriornucleus of the thalamus.

• Adequate organ function as assessed by the following laboratory values within 3weeks 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 verbalconsent for the protocol.

• Patient is a candidate for ANT DBS based on the following criteria established bythe American Society for Stereotactic and Functional Neurosurgeons:

• Confirmed diagnosis of epilepsy by an epileptologist with focal-onset seizures, withor without generalization;

• Failure to adequately control seizures after two (or more) appropriate andadequately-dosed anti-seizure medications;

• Either partial-onset seizures with a localized onset in a region not amenable toresection or following failed resective surgery or focal-onset seizures withdistributed 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 medicalor ----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.