Transplanting patients' own mitochondria to improve heart function after ischemia
Transplantation of Autologously Derived Mitochondria for Protection Against Ischemia-reperfusion Injury Following Ischemia in Subjects on ECMO Support
NA · Boston Children's Hospital · NCT02851758
This study is testing whether injecting children's own mitochondria into their heart can help improve heart function after a lack of blood flow during ECMO treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | N/A to 17 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT02851758 on ClinicalTrials.gov |
What this trial studies
This intervention aims to reduce myocardial ischemia/reperfusion injury in pediatric patients on extracorporeal membrane oxygenation (ECMO) by injecting autologous mitochondria directly into the ischemic heart muscle. The mitochondria are extracted from the patient's own skeletal muscle during a surgical procedure or cardiac catheterization and then injected into the damaged area or the proximal aorta for distribution. This approach seeks to enhance heart recovery and minimize complications associated with ECMO. The study will evaluate the safety and efficacy of this innovative treatment method.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric cardiology patients under 18 years old who are on ECMO and at risk for ischemic injury.
Not a fit: Patients with known mitochondrial disorders may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this treatment could significantly decrease morbidity and mortality in pediatric patients requiring ECMO.
How similar studies have performed: While the approach of using autologous mitochondria is innovative, similar studies have shown promise in related areas, but this specific application is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pediatric cardiology patients under the age of 18 on ECMO * concerns for ischemic injury on the Cardiac Intensive Care Unit Exclusion Criteria: * Known mitochondria disorders
Where this trial is running
Boston, Massachusetts
- Boston Children's Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Sitaram M Emani, MD — Boston Children's Hospital
- Study coordinator: Breanna Piekarski, RN, BSN
- Email: breanna.piekarski@cardio.chboston.org
- Phone: 617-919-4457
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.
Conditions: Extracorporeal Membrane Oxygenation Complication