NCT06280092 · Sanjeet S. Grewal
Allogenic Adipose-derived Mesenchymal Stem Cells(AMSCs) for Epilepsy During Deep Brain Stimulation(DBS) Surgery
What this study is about
This study is a non-randomly assigned, open label, phase 1 clinical trial to evaluate the fesibility and safety of intrathalamic delivery of MSCs during the usual treatment 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participants ≥ 18 years of age.
- Participants with Drug Resistance Epilepsy as defined by the ILAE5.
- 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;
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 10\^9/L.
- Patient or legal guardian is able to fully understand and provide written and verbal consent for the protocol.
- Patient is a candidate for ANT DBS based on the following criteria established by the American Society for Stereotactic and Functional Neurosurgeons:
- Confirmed diagnosis of epilepsy by an epileptologist with focal-onset seizures, with or without generalization;
- Failure to adequately control seizures after two (or more) appropriate and adequately-dosed anti-seizure medications;
- Either partial-onset seizures with a localized onset in a region not amenable to resection or following failed resective surgery or focal-onset seizures with distributed or unclear onset zone.
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.
Where
- Jacksonville, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 24, 2025 · Source of record for eligibility and locations