Infusing healthy mitochondria to treat cerebral ischemia
Study Title: Autologous Mitochondrial Transplant for Cerebral Ischemia
This study is testing whether infusing healthy mitochondria into the brain can help patients with reduced blood flow during a specific treatment for stroke.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT04998357 on ClinicalTrials.gov |
What this trial studies
This study aims to infuse healthy autologous mitochondria into the cerebral vessels of patients experiencing ischemia during standard endovascular reperfusion therapy. The approach is based on preclinical evidence suggesting that mitochondrial damage caused by ischemia can be reversed with such infusions. The trial will assess the safety and feasibility of this novel intervention in human subjects, specifically targeting those eligible for endovascular thrombectomy. The procedure will be conducted concurrently with clinically indicated treatments for acute large vessel occlusion.
Who should consider this trial
Good fit: Ideal candidates are patients eligible for endovascular thrombectomy to treat acute large vessel occlusion.
Not a fit: Patients with known mitochondrial diseases or those who are hemodynamically unstable may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes for patients suffering from ischemic strokes.
How similar studies have performed: Other studies have shown success with similar mitochondrial transplantation approaches in heart conditions, indicating potential for this novel application in the brain.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seattle, Washington
- Harborview Medical Center — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Melanie S Walker, MD — University of Washington
- Study coordinator: Study Coordinator
- Email: sanslab@uw.edu
- Phone: 206-897-5802
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.