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

NCT06280092 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 23-009133
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (2)

• Incidence of AEs related to the study agent

  To investigate the feasibility and safety of local delivery of AMSCs for epilepsy by measuring the incidence of AEs related to the study agent.

  12 months

• Radiographic effects related to the study agent

  To investigate the effects of local delivery of AMSCs for epilepsy as measured by radiographic data on MRI.

  12 months

Study Arms (1)

AMSCs

EXPERIMENTAL

A single dose of 5x10\^6 AMSCs will be resuspended in 1ml of LRS and infused via intraparenchymal at the time of DBS surgery

Drug: AMSCs

Interventions

AMSCs DRUG

A single dose of 5x10\^6 AMSCs will be resuspended in 1ml of LRS and infused via intraparenchymal at the time of DBS surgery

AMSCs

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanjeet S. Grewal: lead

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Sanjeet Grewal, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan J Gauthier, AS

CONTACT

9049535544; Gauthier.Megan2@mayo.edu|

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: This is an unmasked study
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Model Details: A single dose of 5x10\^6 AMSCs will be resuspended in 1ml of LRS and infused via intraparenchymal at the time of DBS surgery

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: December 23, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)