Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMSCs | Experimental | A single dose of 5x10^6 AMSCs will be resuspended in 1ml of LRS and infused via intraparenchymal at the time of DBS surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMSCs | Drug | A single dose of 5x10^6 AMSCs will be resuspended in 1ml of LRS and infused via intraparenchymal at the time of DBS surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AEs related to the study agent | To investigate the feasibility and safety of local delivery of AMSCs for epilepsy by measuring the incidence of AEs related to the study agent. | 12 months |
| Radiographic effects related to the study agent | To investigate the effects of local delivery of AMSCs for epilepsy as measured by radiographic data on MRI. | 12 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Megan J Gauthier, AS | Contact | 9049535544 | Gauthier.Megan2@mayo.edu| |
| Name | Affiliation | Role |
|---|---|---|
| Sanjeet Grewal, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Recruiting | Jacksonville | Florida | 32224 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
A single dose of 5x10^6 AMSCs will be resuspended in 1ml of LRS and infused via intraparenchymal at the time of DBS surgery
Not provided
Not provided
This is an unmasked study
Not provided