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Mitochondrial Transplant for Stroke

N/A

Recruiting

Led By Melanie S Walker, MD

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eligible for angioplasty (microcatheter-based balloon/mechanical and chemical angioplasty) to treat acute cerebral vasospasm after aneurysmal subarachnoid hemorrhage

Eligible for endovascular thrombectomy to treat acute large vessel occlusion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to six hours after procedure completion

Awards & highlights

Study Summary

This trial will infuse healthy mitochondria into the brains of patients who are experiencing ischemia in order to improve their condition.

Who is the study for?

This trial is for patients eligible for endovascular thrombectomy due to acute large vessel occlusion or angioplasty after subarachnoid hemorrhage. Candidates must be stable enough for standard reperfusion treatment and able to give consent. Those with mitochondrial diseases, unable to undergo MRI, or hemodynamically unstable cannot participate.Check my eligibility

What is being tested?

The study tests the infusion of a patient's own healthy mitochondria into brain vessels affected by ischemia during standard endovascular reperfusion therapy. The goal is to see if this can help recover brain tissue that isn't getting enough blood flow due to stroke.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include reactions related to the mitochondrial transplantation procedure itself or complications from the endovascular therapies used in treating cerebral ischemia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a candidate for a special procedure to treat brain vessel narrowing after a specific type of stroke.

Select...

I am a candidate for a procedure to remove a large blood clot in my vessel.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 hours post-mitochondrial infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 hours post-mitochondrial infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 hours post-mitochondrial infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of severe adverse events during mitochondrial infusion

Incidence of severe adverse events related to muscle biopsy

Incidence of severe adverse vascular events immediately post-mitochondrial infusion

+1 more

Secondary outcome measures

Reduction of infarct volume post-mitochondrial infusion

Trial Design

1Treatment groups

Experimental Treatment

Group I: TransplantationExperimental Treatment1 Intervention

Endovascular infusion

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,740 Previous Clinical Trials

1,847,650 Total Patients Enrolled

Melanie S Walker, MDPrincipal InvestigatorUniversity of Washington

Media Library

Endovascular autologous mitochondrial transplantation Clinical Trial Eligibility Overview. Trial Name: NCT04998357 — N/A

Cerebral Ischemia Research Study Groups: Transplantation

Cerebral Ischemia Clinical Trial 2023: Endovascular autologous mitochondrial transplantation Highlights & Side Effects. Trial Name: NCT04998357 — N/A

Endovascular autologous mitochondrial transplantation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04998357 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would I qualify to join in this research endeavor?

"In order to qualify for this clinical trial, applicants must suffer from ischemia, cerebral and be within the 18-85 age range. The study aims to admit 20 individuals in total."

Answered by AI

To what extent is this trial test group being subject to treatment?

"Affirmative, the information posted on clinicaltrials.gov indicates that this medical study is actively searching for participants. This trial was initially put up on April 29th 2021 and has been updated most recently on August 1st 2021. There are 20 slots available at a single site of recruitment."

Answered by AI

Are there vacant opportunities for participants in this research?

"This clinical trial, which was initially advertised on April 29th 2021 is still open for participation and recently edited in August 1st 2021 according to the information provided by clinicaltrials.gov."

Answered by AI

Does this research project accept participants who are above the age of twenty-five?

"Those hoping to be admitted into this medical trial must fall between the ages of 18 and 85. Conversely, there are 48 studies specifically designed for minors, while 396 trials focus on those over 65 years in age."

Answered by AI

Has the FDA provided its stamp of approval for Endovascular autologous mitochondrial transplantation?

"Due to the lack of evidence for both safety and efficacy, our team at Power has assigned Endovascular autologous mitochondrial transplantation a conservative rating of 1 on a scale from 1 to 3."

Answered by AI

Recent research and studies

Journal of Visualized ExperimentsJournal

Rapid Isolation and Purification of Mitochondria for Transplantation by Tissue Dissociation and Differential Filtration

Preble, Janine M., Christina A. Pacak, Hiroshi Kondo, Allison A. MacKay, Douglas B. Cowan, and James D. McCully. 2014. “Rapid Isolation and Purification of Mitochondria for Transplantation by Tissue Dissociation and Differential Filtration”. Journal of Visualized Experiments. MyJove Corporation. doi:10.3791/51682.

Molecular NeurobiologyJournal

Mitochondrial Quality Control in Cerebral Ischemia–reperfusion Injury

Wu, Mimi, Xiaoping Gu, and Zhengliang Ma. 2021. “Mitochondrial Quality Control in Cerebral Ischemia–reperfusion Injury”. Molecular Neurobiology. Springer Science and Business Media LLC. doi:10.1007/s12035-021-02494-8.

The Journal of Thoracic and Cardiovascular SurgeryJournal

Autologous Mitochondrial Transplantation for Cardiogenic Shock in Pediatric Patients Following Ischemia-reperfusion Injury

Guariento, Alvise, Breanna L. Piekarski, Ilias P. Doulamis, David Blitzer, Alessandra M. Ferraro, David M. Harrild, David Zurakowski, Pedro J. del Nido, James D. McCully, and Sitaram M. Emani. 2021. “Autologous Mitochondrial Transplantation for Cardiogenic Shock in Pediatric Patients Following Ischemia-reperfusion Injury”. The Journal of Thoracic and Cardiovascular Surgery. Elsevier BV. doi:10.1016/j.jtcvs.2020.10.151.

American Journal of Physiology-Renal PhysiologyJournal