Mitochondrial transplantation for therapeutic use.
James D McCully, Sidney Levitsky, Pedro J Del Nido...
https://pubmed.ncbi.nlm.nih.gov/27130633/Actively Recruiting
Led by University of Washington · Updated on 2025-05-21
20
Participants Needed
1
Research Sites
26 weeks
Total Duration
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 mitochondriatiny energy-producing parts of cellsinto 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 patients 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
Autologous Mitochondrial Transplant for Cerebral Ischemia
S
Study Coordinator
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
University of Washington
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Mitochondrial Transplantation with Endovascular Therapy | Current Endovascular Reperfusion Therapy |
|---|---|---|
| What it is | Participants receive an infusion of mitochondria isolated from their own muscle, administered by microcatheter directly into the brain’s affected vessel during standard endovascular reperfusion or angioplasty for acute cerebral ischemia. | Standard care involves endovascular thrombectomy for acute large vessel cerebral occlusion or microcatheter-based angioplasty for treatment of cerebral vasospasm after subarachnoid hemorrhage, without additional mitochondrial transplantation. |
| Role in study or care | Tested as an investigational add-on therapy to determine its safety and feasibility when performed during standard reperfusion procedures. | Serves as the established standard treatment for acute endovascular management of large-vessel occlusive stroke or cerebral vasospasm. |
| Primary use or goal | To assess whether infusing autologous mitochondria during endovascular therapy is safe, and explore if it might protect brain tissue or improve recovery from cerebral ischemia. | Aims to reopen blocked or narrowed blood vessels and restore brain circulation as quickly and safely as possible to minimize neurological injury from stroke or vasospasm. |
| How it is given or performed | Muscle tissue is harvested from the participant, mitochondria are rapidly isolated, and then infused through a microcatheter into the affected brain artery during the endovascular procedure. | Thrombectomy and angioplasty are performed using standard endovascular catheter techniques, without additional biologic infusion. |
| Evidence status | Early clinical evidence; effectiveness and long-term benefits are unproven. Preclinical studies and a small phase 1 trial suggest biological feasibility and safety, but definitive benefit or harm in cerebral ischemia has not been established. | Extensive published evidence supports the safety and benefit of rapid endovascular therapy to restore cerebral blood flow, with improved clinical outcomes when performed promptly in eligible stroke or vasospasm patients. |
| Important limitations | Only early-phase safety and feasibility data are available; unknown effects on long-term recovery, neurological outcome, or infarct volume. Procedural complexity, muscle biopsy, and mitochondrial preparation add operative steps. Not yet studied in large randomized trials for stroke. | While effective at reopening blocked vessels, standard therapy does not reverse established brain injury, and some patients may still experience significant neurological deficits despite timely intervention. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Have more questions? Get in touch with our team for quick support
James D McCully, Sidney Levitsky, Pedro J Del Nido...
https://pubmed.ncbi.nlm.nih.gov/27130633/Pedro Norat, Jennifer D Sokolowski, Catherine M Gorick...
https://pubmed.ncbi.nlm.nih.gov/37545759/Melanie Walker, Michael R Levitt, Emma M Federico...
https://pubmed.ncbi.nlm.nih.gov/39628322/Joonho Suh, Yun-Sil Lee
https://pubmed.ncbi.nlm.nih.gov/38172601/Alvise Guariento, Breanna L Piekarski, Ilias P Doulamis...
https://pubmed.ncbi.nlm.nih.gov/33349443/Pedro Norat, Sauson Soldozy, Jennifer D Sokolowski...
https://pubmed.ncbi.nlm.nih.gov/33298971/Ilias P Doulamis, Alvise Guariento, Thomas Duignan...
https://pubmed.ncbi.nlm.nih.gov/32686525/Viktoria Weixler, Razvan Lapusca, Gernot Grangl...
https://pubmed.ncbi.nlm.nih.gov/32919774/Janine M Preble, Christina A Pacak, Hiroshi Kondo...
https://pubmed.ncbi.nlm.nih.gov/25225817/Mimi Wu, Xiaoping Gu, Zhengliang Ma
https://pubmed.ncbi.nlm.nih.gov/34275087/University of Washington
Lead Sponsor