NCT06280092

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

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Sanjeet S. Grewal · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

To investigate the feasibility and safety of local delivery of AMSCs for epilepsy by measuring the incidence of AEs related to the study agent. To investigate the effects of local delivery of AMSCs for epilepsy as measured by radiographic data on MRI.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	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

Timeline

• Start date: 2024-12-23
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2024-02-28
• Last updated: 2025-04-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study