Autologous Mitochondrial Transplant for Cerebral Ischemia
This study is testing a new approach called autologous mitochondrial transplantation for people experiencing cerebral ischemia (a type of stroke caused by lack of blood flow to the brain). During a standard procedure to restore blood flow, your own healthy mitochondria (tiny parts of cells that produce energy) would be infused into the affected brain area. The main goal of this study is to see if this treatment is safe, by looking for any serious side effects during and shortly after the infusion, and up to seven days later. This study is for adults aged 18 to 85 who are eligible for certain standard stroke treatments. The study plans to enroll 20 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 20 participants, but the phase of the study is not specified.
- What's involved
- You would receive an infusion of your own mitochondria during a standard endovascular reperfusion procedure for stroke. The study will monitor you for side effects during and immediately after the infusion, and for up to seven days after the procedure.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be monitored for severe adverse events during the mitochondrial infusion, up to three hours post-infusion, and up to seven days after the procedure completion.
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Autologous Mitochondrial Transplant for Cerebral Ischemia
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Melanie S Walker, MD · PRINCIPAL_INVESTIGATOR · University of Washington
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Incidence of severe adverse events during mitochondrial infusionThrough completion of reperfusion therapy, up to one hour post-infusion
Cerebral angiography is performed and reviewed in real-time throughout the standard of care reperfusion treatment, including before and after microcatheter infusion of mitochondria.
- Incidence of severe adverse vascular events immediately post-mitochondrial infusionUp to 3 hours post-mitochondrial infusion
Post-reperfusion therapy, CT scans are performed as part of the standard of care. The post-procedure CT scan will be reviewed for severe adverse events associated with the microcatheter infusion of mitochondria.
- Incidence of severe systemic adverse events associated with mitochondrial infusionUp to seven days after procedure completion
Post-reperfusion therapy, peripheral blood studies are performed and reviewed as part of the standard of care to assess systemic function. These include complete blood counts, coagulation studies, and serum chemistry.
- Incidence of severe adverse events related to muscle biopsyUp to six hours after procedure completion
Muscle biopsy is obtained through the same incision as vascular access. The access site is evaluated via physical examination by medical personnel for six hours post-intervention per standard of care protocol.