Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04998357
Study type Interventional
Source University of Washington
Contact Study Coordinator
Phone 206-897-5802
Email sanslab@uw.edu
Status Recruiting
Phase N/A
Start date April 29, 2021
Completion date October 29, 2026

See also
  Status Clinical Trial Phase
Completed NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Recruiting NCT04167527 - Endovascular Therapy for Low NIHSS Ischemic Strokes Phase 2/Phase 3
Recruiting NCT04583163 - Variability in Transcranial Doppler Technique in Neuro-Critical Care Patients
Completed NCT01436812 - Effect of Positive End Expiratory Pressure (PEEP) on Cerebral Oxymetry During Laparoscopy N/A
Terminated NCT00141011 - Ancrod (Viprinex™) for the Treatment of Acute, Ischemic Stroke Phase 3
Recruiting NCT05053932 - Long-term Comparative Cerebrovascular Outcome After Transplantation vs Standard Care in Sickle Cell Anemia
Completed NCT04437862 - A Study to Evaluate the Q Revascularization System for Neurointervention in Acute Ischemic Stroke N/A
Completed NCT00598819 - A Prospective Study of a New Device for Monitoring Cerebral Oxygenation on Healthy Volunteers Phase 1
Completed NCT00207961 - The Threshold Value of Regional Cerebral Oxygenation in Detecting Cerebral Ischemia N/A
Not yet recruiting NCT04696523 - Effect of Xenon on Brain Injury After Aneurysmal Subarachnoid Hemorrhage Phase 2
Completed NCT02351518 - Cerebral Autoregulation and Vasospasm in Patients With TBI
Completed NCT01546636 - The Effect of Ventilation on Cerebral Oxygenation in the Sitting Position N/A
Completed NCT04047563 - Efficacy of Sovateltide (PMZ-1620) in Patients of Acute Ischemic Stroke Phase 3
Completed NCT05087836 - Correlation of Cerebral Oxygen Saturation Measured From 2 Sensor Sites: Forehead vs. Temporal
Completed NCT02448069 - Safety and Feasibility of Argatroban, Tissue Plasminogen Activator and Intra-arterial Therapy in Stroke Phase 2
Completed NCT02147275 - Monitoring Hypertensive Patients's Cerebral Oxygen Saturation N/A
Completed NCT01875055 - Reversing Cerebral Oxygen Desaturations Greater That 10% of Baseline Values Using NIRS in the ICU N/A
Completed NCT02389647 - Identification of Novel Molecular Markers for Cerebral Ischemia From Patients With Minor and Devastating Ischemic Injury
Completed NCT02643030 - Hypercapnia During Shoulder Arthroscopy N/A
Completed NCT01436799 - Desflurane Versus Propofol in the Sitting Position N/A