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

Launched by SANJEET S. GREWAL · Feb 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of specialized cells called allogenic adipose-derived mesenchymal stem cells (AMSCs) to see if they can help reduce seizures in people with epilepsy during a surgery known as deep brain stimulation (DBS). The trial aims to find out if delivering these cells directly into a specific part of the brain can be done safely and effectively while performing standard DBS surgery.

To participate, individuals must be 18 years or older, have epilepsy that has not responded to at least two medications, and be eligible for DBS surgery. Participants will undergo a routine pre-surgery evaluation, including blood tests and an MRI scan, before the procedure. After the surgery, they will be monitored for up to a year to track their health and any changes in their epilepsy. It's important to note that certain medical conditions may exclude someone from participating, such as having had previous brain surgery for epilepsy or being pregnant. Overall, this trial is an opportunity to explore new treatment options for those struggling with epilepsy.

Gender

ALL

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.