Stem Cells for Epilepsy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety of using stem cells to help treat epilepsy during deep brain stimulation (DBS) surgery. It focuses on individuals whose epilepsy does not respond well to medication and who are already scheduled for DBS surgery. Participants will receive a dose of allogenic adipose-derived mesenchymal stem cells during their DBS surgery to assess safety and feasibility. Ideal candidates have tried multiple epilepsy medications without success and are set for DBS surgery. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, since the trial involves patients with drug-resistant epilepsy, it is likely that you will continue your current anti-seizure medications.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that stem cells taken from donated fat tissue, known as allogenic adipose-derived mesenchymal stem cells (AMSCs), are promising in early studies. In one study, 83 patients received these stem cells, and researchers found no major safety issues. Additionally, studies in animals, such as rats, have shown that AMSCs can help reduce seizures without causing significant harm.
While these early results suggest the treatment is generally safe, the current trial remains in its early stages. Researchers are primarily assessing safety and practicality. Although the initial data is encouraging, more research is needed to fully understand its safety in humans.12345Why do researchers think this study treatment might be promising for epilepsy?
Unlike the standard epilepsy treatments, which typically include medications like antiepileptic drugs (AEDs) to manage seizures, this new approach uses allogenic adipose-derived mesenchymal stem cells (AMSCs). These stem cells are unique because they can potentially repair or replace damaged brain tissue, offering a fresh avenue for treatment beyond merely controlling symptoms. Moreover, AMSCs are delivered directly to the brain during DBS (deep brain stimulation) surgery, ensuring precise targeting of the affected areas. Researchers are excited about this treatment because it offers a novel mechanism of action that could lead to more effective and long-lasting results for epilepsy patients.
What evidence suggests that this treatment might be an effective treatment for epilepsy?
Research suggests that Allogenic Adipose-derived Mesenchymal Stem Cells (AMSCs) might help reduce seizures in people with epilepsy. In studies with rats that had epilepsy, these stem cells significantly lowered seizure activity. They appear to aid by repairing brain tissue and reducing inflammation. Although direct evidence from human studies remains limited, these stem cells have shown promise in treating other brain-related conditions, indicating potential effectiveness for epilepsy. This treatment is still under investigation in this trial, but early results are encouraging.12678
Who Is on the Research Team?
Sanjeet Grewal, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for adults over 18 with Drug-Resistant Epilepsy planning to undergo deep brain stimulation (DBS) surgery. They must have normal or slightly elevated blood clotting times, liver function tests within certain limits, and adequate kidney function. Participants need a hemoglobin level of at least 9 g/dL, platelets count above 100 x 10^9/L, and an absolute neutrophil count over 1.5 x 10^9/L.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Evaluation
Standard preoperative evaluation including baseline laboratory values and high-definition MRI
Surgery and Treatment
Stereotactic procedure for bilateral thalamic implantation of DBS leads and infusion of AMSCs
Follow-up
Participants are monitored for safety and effectiveness after treatment, including surgical, clinical, and radiographic data collection
What Are the Treatments Tested in This Trial?
Interventions
- Allogenic Adipose-derived Mesenchymal Stem Cells
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Who Is Running the Clinical Trial?
Sanjeet S. Grewal
Lead Sponsor