Pilot Study of Allogenic Adipose-derived Mesenchymal Stem Cells Delivered During Deep Brain Stimulation Surgery for Epilepsy

What this Trial Is About

Researchers are evaluating the feasibility and safety of delivering allogenic adipose-derived mesenchymal stem cells AMSCs directly into the thalamus during standard deep brain stimulation DBS surgery for epilepsy. This early phase 1, non-randomized, open-label trial aims to study the effects and safety of this local cell therapy by monitoring adverse events and radiographic changes on MRI over 12 months. The study focuses on patients with drug-resistant epilepsy undergoing bilateral DBS lead implantation targeting the anterior nucleus of the thalamus. Participants will receive a single dose of 5 million AMSCs suspended in 1 ml of lactated Ringers solution, infused directly into the anterior nucleus of the thalamus during the stereotactic DBS surgery using the ClearPoint system. This infusion is done just before the DBS leads are implanted. The trial does not include randomization or blinding, and all enrolled participants receive the experimental treatment during their surgery. During the study, patients will be followed in outpatient settings for up to one year after the therapy. Researchers will collect surgical, clinical, and imaging data at visits throughout this period to assess safety and radiographic effects related to the stem cell infusion. Baseline labs and high-definition MRI scans will be done before surgery to establish initial health and brain structure. The main outcomes include monitoring for adverse events linked to the treatment and changes seen on MRI over 12 months.

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