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Allogenic Adipose-derived Mesenchymal Stem Cells(AMSCs) for Epilepsy During Deep Brain Stimulation(DBS) Surgery
Sponsor: Sanjeet S. Grewal
Summary
This study is a non-randomized, open label, phase 1 clinical trial to evaluate the fesibility and safety of intrathalamic delivery of MSCs during standard of care DBS surgery for epilepsy. Subjects will be screened at our outpatient clinic and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained, patients will undergo a standard preoperative evaluation which includes baseline laboratory values and a high-definition MRI. Patients will then undergo a stereotactic procedure for bilateral thalamic implantation of DBS leads through the ClearPoint® system. After the thalamic target for DBS is identified, cells will be infused directly into the anterior nucleus of the thalamus previous to lead implantation. Patients will be followed in the outpatient setting for up to a year after therapy application. Surgical, clinical, and radiographic data will be obtained during these visits
Official title: A Pilot Study to Evaluate the Feasibility and Safety of Allogenic Adipose-derived Mesenchymal Stem Cells(AMSCs) for Epilepsy During Deep Brain Stimulation(DBS) Surgery
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
5
Start Date
2024-12-23
Completion Date
2026-03
Last Updated
2025-04-24
Healthy Volunteers
No
Conditions
Interventions
AMSCs
A single dose of 5x10\^6 AMSCs will be resuspended in 1ml of LRS and infused via intraparenchymal at the time of DBS surgery
Locations (1)
Mayo Clinic
Jacksonville, Florida, United States