RECRUITING

Allogenic Adipose-derived Mesenchymal Stem Cells(AMSCs) for Epilepsy During Deep Brain Stimulation(DBS) Surgery

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. Surgical, clinical, and radiographic data will be obtained during these visits

Official Title

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

Quick Facts

Study Start:2024-12-23

Study Completion:2025-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06280092

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Megan J Gauthier, AS

CONTACT

9049535544

Gauthier.Megan2@mayo.edu|

Principal Investigator

Sanjeet Grewal, MD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic

Jacksonville, Florida, 32224

United States

Collaborators and Investigators

Sponsor: Sanjeet S. Grewal

Sanjeet Grewal, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-23

Study Completion Date2025-03

Study Record Updates

Study Start Date2024-12-23

Study Completion Date2025-03

Terms related to this study

Additional Relevant MeSH Terms

Epilepsy