Autologous Mitochondrial Transplant for Cerebral Ischemia
ConditionCerebral Ischemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Washington
About this trial
The investigators propose to infuse healthy autologous mitochondria into cerebral vessels supplying brain tissue experiencing ischemia in patients who undergo standard-of- care endovascular reperfusion therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Eligible for endovascular thrombectomy to treat acute large vessel occlusion
Eligible for angioplasty (microcatheter-based balloon/mechanical and chemical angioplasty) to treat acute cerebral vasospasm after aneurysmal subarachnoid hemorrhage
Subjects for whom there is likely to be enough time to obtain meaningful consent from patient or legally-authorized representative
Disqualifiers
Unable to receive a brain MRI scan
Known mitochondrial disease
Hemodynamically unstable patients in whom standard of care endovascular reperfusion treatment cannot safely be performed or completed
Trial design
Design model
Single group
Treatments tested in this trial
Endovascular autologous mitochondrial transplantation
Other interventionDuring standard-of-care endovascular reperfusion procedure, subjects will have autologous mitochondria infused via microcatheter into ischemic brain.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: TransplantationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of severe adverse events during mitochondrial 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.
Time frame
Through completion of reperfusion therapy, up to one hour post-infusion2
Incidence of severe adverse vascular events immediately 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.
Time frame
Up to 3 hours post-mitochondrial infusion3
Incidence of severe systemic adverse events associated with mitochondrial infusion
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.
Time frame
Up to seven days after procedure completion4
Incidence of severe adverse events related to muscle biopsy
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.
Time frame
Up to six hours after procedure completionSecondary outcomes
1
Reduction of infarct volume post-mitochondrial infusion
Patients undergo brain MRI as part of standard of care evaluation after reperfusion therapy. These studies are compared with initial brain imaging studies obtained prior to reperfusion therapy.
Time frame
Up to seven days after procedure completion.Sponsors and contacts
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Source ClinicalTrials.gov