Transplanting patients' own mitochondria to improve heart function after ischemia
Official title: Transplantation of Autologously Derived Mitochondria for Protection Against Ischemia-reperfusion Injury Following Ischemia in Subjects on ECMO Support
Run by Boston Children's Hospital · NCT02851758 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | Any age to 17 Years |
| Sex | All |
| Enrollment | 16 (estimated) |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | August 2, 2017 |
| Main results expected | June 2027 |
| Study ends | June 2027 |
| Registry record updated | January 5, 2026 |
| Trial ID | NCT02851758 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with known mitochondrial disorders may not benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
Why it matters
Potential benefit: If successful, this treatment could significantly decrease morbidity and mortality in pediatric patients requiring ECMO.
How similar studies have gone: While the approach of using autologous mitochondria is innovative, similar studies have shown promise in related areas, but this specific application is novel.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Safety and performance of the Novalung kit and Xenios 2.0 during stationary use for patients on ECMO
This observational study tests whether using the Novalung ultimate kit with Xenios 2.0 (and MultiSupport Ground) helps maintain blood oxygenation in adults on ECMO during hospital stay and ground transport.
-
Using near apneic ventilation with ECMO for severe respiratory distress
This study is testing if a new way of breathing support called near apneic ventilation can help patients with severe respiratory distress on ECMO recover better and faster than the usual care.
-
Using cangrelor to improve outcomes in patients with cardiogenic shock on ECMO
This study is testing if adding a medication called cangrelor can help patients in cardiogenic shock on ECMO have better outcomes while reducing bleeding risks during their treatment.
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Investigating left ventricle unloading during extracorporeal life support
This study looks at how different methods of relieving pressure on the heart can help patients on a special life support system called VA ECLS, especially those in serious heart trouble.
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MiniLung petite kit for neonates and infants with severe respiratory or cardiac failure
We will test whether the MiniLung petite kit with the Xenios console safely improves oxygenation, removes CO2, and stabilizes circulation in newborns and young infants (2–8 kg) with severe respiratory or cardiopulmonary failure.
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RECOMMEND platform testing interventions for adults receiving ECMO
This platform tests whether different treatments, such as liberal versus restrictive red blood cell transfusion strategies, help adults on ECMO survive and need less organ support and hospital resources by day 28.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.