Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
ID04998357

Autologous Mitochondrial Transplant for Cerebral Ischemia During Standard Endovascular Reperfusion Therapy

Led by University of Washington · Updated on 2025-05-21

20

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Stroke is a leading cause of disability and death worldwide, with more than 80% of cases caused by blocked blood flow to the brain, which leads to cell death. Researchers are investigating whether infusing healthy mitochondria—tiny energy-producing parts of cells—into brain vessels during standard treatment can help reverse damage caused by this lack of blood flow. This study is the first to test this approach in human brains, building on previous animal studies and heart trials that showed safety and potential benefits. The study involves patients who are undergoing standard endovascular reperfusion therapy to restore blood flow after cerebral ischemia. During this procedure, a small muscle biopsy will be taken near the surgical site to extract the patient's own mitochondria. These healthy mitochondria will then be infused directly into the brain artery through a microcatheter as part of the ongoing reperfusion treatment, without interrupting the standard care. Participants will be monitored closely for safety during and after the mitochondrial infusion, including checks for severe adverse events related to the infusion or muscle biopsy up to seven days post-procedure. Researchers will also assess the reduction in brain tissue damage after the treatment. The total study participation includes the procedure and follow-up safety monitoring, aiming to confirm the safety and feasibility of this novel mitochondrial transplant during brain ischemia treatment.

CONDITIONS

Brief Title

Autologous Mitochondrial Transplant for Cerebral Ischemia

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Eligible for endovascular thrombectomy to treat acute large vessel occlusion
  • Eligible for angioplasty to treat acute cerebral vasospasm after aneurysmal subarachnoid hemorrhage
  • Able to provide meaningful consent or have a legally-authorized representative consent on your behalf
Not Eligible

You will not qualify if you...

  • Unable to receive a brain MRI scan
  • Known mitochondrial disease
  • Hemodynamically unstable patients unable to safely complete standard endovascular reperfusion treatment

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single procedure day

Participants undergo standard-of-care endovascular reperfusion therapy during which a small muscle biopsy is taken to extract autologous mitochondria. These mitochondria are infused into the brain artery via micro-catheter during the reperfusion procedure.

1 treatment visit (in-person)

Follow-up

Duration - Up to 7 days after procedure completion

Participants are monitored for adverse events and treatment effects after the mitochondrial infusion, including vascular and systemic safety assessments and infarct volume reduction evaluations.

Approximately 1 to 3 visits following treatment

Trial Site Locations

Total: 1 location

1

Harborview Medical Center

Seattle, Washington, United States, 98104

Actively Recruiting

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Research Team

S

Study Coordinator

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Rapid isolation and purification of mitochondria for transplantation by tissue dissociation and differential filtration.

Janine M Preble, Christina A Pacak, Hiroshi Kondo...

https://pubmed.ncbi.nlm.nih.gov/25225817

Autologous mitochondrial transplantation for cardiogenic shock in pediatric patients following ischemia-reperfusion injury.

Alvise Guariento, Breanna L Piekarski, Ilias P Doulamis...

https://pubmed.ncbi.nlm.nih.gov/33349443