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

NCT06280092 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-04-24

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Sanjeet S. Grewal

    lead OTHER

Principal Investigators

  • Sanjeet Grewal, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-23
Primary Completion
2026-03-31
Completion
2026-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06280092 on ClinicalTrials.gov