Recruiting

Autologous Mitochondrial Transplant

Sponsor:

University of Washington

Code:

NCT04998357

Conditions

Cerebral Ischemia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Endovascular autologous mitochondrial transplantation

Study Details

Brief summary:

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.

Conditions

Cerebral Ischemia

Study ID

NCT04998357

Start date

Apr 29, 2021

Status verified date

May, 2025

Completion date

Oct 29, 2026

Anticipated

Primary completion date

Apr 29, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Transplantation

Endovascular infusion

Interventions

Endovascular autologous mitochondrial transplantation

During standard-of-care endovascular reperfusion procedure, subjects will have autologous mitochondria infused via microcatheter into ischemic brain.

Primary outcome measure

  • Incidence of severe adverse events during mitochondrial infusion [ Time Frame: Through completion of reperfusion therapy, up to one hour post-infusion ]
  • Incidence of severe adverse vascular events immediately post-mitochondrial infusion [ Time Frame: Up to 3 hours post-mitochondrial infusion ]
  • Incidence of severe systemic adverse events associated with mitochondrial infusion [ Time Frame: Up to seven days after procedure completion ]
  • Incidence of severe adverse events related to muscle biopsy [ Time Frame: Up to six hours after procedure completion ]

Central Contacts and Locations

Central contacts

Study Coordinator

206-897-5802sanslab@uw.edu

Locations

Harborview Medical Center

Recruiting

Seattle, Washington, United States, 98104

Contacts

Melanie Walker, MD

206-744-3000

More Information

Sponsor

University of Washington

Last update posted

May 21, 2025

Last verified

May, 2025

Keywords

  • autologous mitochondrial transplantation
  • ischemic stroke

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2025-05-21.