EpilepsyEarly Phase 1NCT06280092
Allogenic Adipose-derived Mesenchymal Stem Cells(AMSCs) for Epilepsy During Deep Brain Stimulation(DBS) Surgery
A Early Phase 1 study testing AMSCs in people with Epilepsy, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- AMSCs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2024to 3 Sep 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
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- Subjects allergic to any component of the investigational product.
- Subjects > 75 years of age.
- Cognitively impaired adults.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
Read the 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.
- Conditions
- Epilepsy
- Being tested
- AMSCs
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMSCsDrug
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: AMSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start23 Dec 2024
- Primary completion3 Sep 2026
- Study completion3 Sep 2026
Why it stopped: PI has passed away
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single dose of 5x10\^6 AMSCs will be resuspended in 1ml of LRS and infused via intraparenchymal at the time of DBS surgery
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanjeet Grewal, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280092
- Sponsor's protocol ID
- 23-009133
- Status last verified
- Sep 2026
- First submitted
- 20 Feb 2024
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06280092
- Acronym / sponsor ID
- 23-009133
- Conditions
- Epilepsy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI has passed away
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- 3 Sep 2026 (actual)
- Study completion
- 3 Sep 2026 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single dose of 5x10^6 AMSCs will be resuspended in 1ml of LRS and infused via intraparenchymal at the time of DBS surgery
| Arm | Type | Receives |
|---|---|---|
| AMSCs | Experimental | Drug: AMSCsA single dose of 5x10^6 AMSCs will be resuspended in 1ml of LRS and infused via intraparenchymal at the time of DBS surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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;
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMSCsA 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 |
Primary outcome
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.
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.
Results and safety
The study was stopped early (reason given: PI has passed away). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Epilepsy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjeet Grewal, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing AMSCs in people with Epilepsy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: PI has passed away). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AEs related to the study agent (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.