Autologous Mitochondrial Transplant for Cerebral Ischemia

May 15, 2025 updated by: Melanie Walker, University of Washington

Study Title: Autologous Mitochondrial Transplant for Cerebral Ischemia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Stroke is one of the leading causes of morbidity and mortality worldwide. More than 80% of strokes are the result of ischemia caused by blockage of one or more cerebral arteries. Lack of blood supply starves brain cells of necessary glucose and oxygen, and disturbs cellular homeostasis, eventually resulting in neuronal death.

Mitochondria are tiny organelles present in nearly all types of human cells and are vital to our survival. Much like a battery, they generate most of our adenosine triphosphate (ATP), the energy currency of the cell. Mitochondria are also involved in other tasks, such as signaling between cells and cell death. All these functions can be impaired during ischemia because of the damage caused to mitochondria.

Based on many preclinical studies in animals, damage caused by ischemia can be reversed after infusing healthy mitochondria into injured tissues. An ongoing clinical trial in human hearts at Boston Children's Hospital has also demonstrated that transplanting autologous mitochondria via infusion or direct injection is well-tolerated and safe.

The investigators at the University of Washington are recruiting subjects for a first-in-human-brain trial to confirm the safety of autologous mitochondrial transplant during brain ischemia. The transplantation will be performed within the same procedure as the clinically indicated reperfusion treatment.

During standard-of-care endovascular treatment for cerebral ischemia, the investigators will obtain a very small biopsy from the muscle tissue adjacent to our surgical access site. Muscle tissue will be processed at bedside to extract the autologous mitochondria as performed in prior human cardiac trial and validated in animal studies. The endovascular treatment proceeds without disruption as clinically indicated, and the mitochondria are infused into the brain artery via micro-catheter during reperfusion.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Study Coordinator
  • Phone Number: 206-897-5802
  • Email: sanslab@uw.edu

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Harborview Medical Center
        • Contact:
          • Melanie Walker, MD
          • Phone Number: 206-744-3000
        • Sub-Investigator:
          • Michael Levitt, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transplantation
Endovascular infusion
Other: Endovascular autologous mitochondrial transplantation
During standard-of-care endovascular reperfusion procedure, subjects will have autologous mitochondria infused via microcatheter into ischemic brain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of severe adverse events during mitochondrial infusion
Time Frame: Through 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.
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
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.
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
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.
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
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.
Up to six hours after procedure completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of infarct volume post-mitochondrial infusion
Time Frame: Up to seven days after procedure completion.
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.
Up to seven days after procedure completion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Investigators

  • Principal Investigator: Melanie S Walker, MD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2021

Primary Completion (Estimated)

April 29, 2026

Study Completion (Estimated)

October 29, 2026

Study Registration Dates

First Submitted

July 21, 2021

First Submitted That Met QC Criteria

August 1, 2021

First Posted (Actual)

August 10, 2021

Study Record Updates

Last Update Posted (Actual)

May 21, 2025

Last Update Submitted That Met QC Criteria

May 15, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00006638

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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