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
Overview
- Phase
- Early Phase 1
- Intervention
- AMSCs
- Conditions
- Epilepsy
- Sponsor
- Sanjeet S. Grewal
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Radiographic effects related to the study agent
- Status
- Recruiting
- Last Updated
- last year
Overview
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
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.
Investigators
Sanjeet S. Grewal
Sponsor-Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •Participants ≥ 18 years of age.
- •Participants with Drug Resistance Epilepsy as defined by the ILAE
- •Participants undergoing bilateral implantation of DBS leads into the anterior nucleus of the thalamus.
- •Adequate organ function as assessed by the following laboratory values within 3 weeks prior to admission to the study:
- •Serum creatinine and urea \< 2 times the upper limit of normal;
- •ALT, AST and alkaline phosphatase \< 3 times the upper limit of normal, and bilirubin \< 2.5 mg/dL;
- •Prothrombin time ≤ 1.5 times upper limit of normal;
- •INR and PTT ≤ 1.5 times the upper limit of normal;
- •Hemoglobin ≥ 9 g/dL;
- •Platelets ≥ 100 x 10\^9/L;
Exclusion Criteria
- •Patients who have undergone a prior intracranial procedure for epilepsy.
- •Patients with an intracranial tumor.
- •Confirmed pregnancy.
- •History of cancer not in remission for at least 5 years.
- •History of diabetes, chronic renal failure, or other significant underlying medical or ----immunosuppressive conditions.
- •History of drug or alcohol abuse.
- •Subjects allergic to any component of the investigational product.
- •Subjects \> 75 years of age.
- •Cognitively impaired adults.
Arms & Interventions
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
Intervention: AMSCs
Outcomes
Primary Outcomes
Radiographic effects related to the study agent
Time Frame: 12 months
To investigate the effects of local delivery of AMSCs for epilepsy as measured by radiographic data on MRI.
Incidence of AEs related to the study agent
Time Frame: 12 months
To investigate the feasibility and safety of local delivery of AMSCs for epilepsy by measuring the incidence of AEs related to the study agent.