Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-28 @ 10:54 AM
Study NCT ID:
NCT06280092
Status:
RECRUITING
Last Update Posted:
2025-04-24
First Post:
2024-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Allogenic Adipose-derived Mesenchymal Stem Cells(AMSCs) for Epilepsy During Deep Brain Stimulation(DBS) Surgery
Sponsor:
Sanjeet S. Grewal
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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.
To investigate the effects of local delivery of AMSCs for epilepsy as measured by radiographic data on MRI.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: