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NCT06280092Not yet recruiting

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
Sanjeet S. GrewalPhase 1ClinicalTrials.govdrug
Study focus
Disease/Condition
Epilepsy
Drug/Device/Intervention
AMSCs
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Sanjeet S. Grewal
Funder
Mayo Clinic
Timeline & enrollment
Phase
Phase 1
Start date
Mar 01, 2024
End date
Mar 01, 2025
Enrollment
5 participants
Primary outcome

Primary Objective,Secondary Objective

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

ICD-10 classifications
EpilepsyEpilepsy, unspecifiedOther epilepsyStatus epilepticusOther status epilepticus
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06280092
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06280092 through Pure Global AI's free database. This Phase 1 trial is sponsored by Sanjeet S. Grewal and is currently Not yet recruiting. The study focuses on Epilepsy. Target enrollment is 5 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.