Actively Recruiting
Allogenic Adipose-derived Mesenchymal Stem Cells(AMSCs) for Epilepsy During Deep Brain Stimulation(DBS) Surgery
Led by Sanjeet S. Grewal · Updated on 2025-04-24
5
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Allogenic Adipose-derived Mesenchymal Stem Cells(AMSCs) for Epilepsy During Deep Brain Stimulation(DBS) Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants 18 years of age or older
- Diagnosis of drug-resistant epilepsy according to ILAE5 criteria
- Scheduled for bilateral implantation of DBS leads into the anterior nucleus of the thalamus
- Adequate organ function according to laboratory tests within 3 weeks prior to study admission:
- Serum creatinine and urea less than 2 times the upper limit of normal
- ALT, AST, alkaline phosphatase less than 3 times the upper limit of normal; bilirubin less than 2.5 mg/dL
- Prothrombin time less than or equal to 1.5 times upper limit of normal
- INR and PTT less than or equal to 1.5 times upper limit of normal
- Hemoglobin 9 g/dL or higher
- Platelets 100 x 10^9/L or higher
- Absolute Neutrophil Count 1.5 x 10^9/L or higher
- Ability to understand and provide written and verbal consent
- Candidate for anterior nucleus of the thalamus DBS based on criteria:
- Confirmed epilepsy diagnosis by epileptologist with focal-onset seizures, with or without generalization
- Failure to control seizures after two or more appropriate anti-seizure medications
- Partial-onset seizures with localized onset not suitable for resection or after failed surgery, or focal-onset seizures with unclear onset zone
You will not qualify if you...
- Prior intracranial surgery for epilepsy
- Presence of intracranial tumor
- Confirmed pregnancy
- History of cancer not in remission for at least 5 years
- History of diabetes, chronic renal failure, or other significant medical or immunosuppressive conditions
- History of drug or alcohol abuse
- Allergy to any component of the investigational product
- Older than 75 years of age
- Cognitive impairment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
Research Team
M
Megan J Gauthier, AS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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