Recruiting

Mitochondria Transplantation

Sponsor:

Boston Children's Hospital

Code:

NCT02851758

Conditions

Extracorporeal Membrane Oxygenation Complication

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

autologous mitochondria transplantation

Study Details

Brief summary:

The investigators propose a robust therapeutic intervention to ameliorate myocardial ischemia/ reperfusion injury and significantly decrease morbidity and mortality in patients requiring extracorporeal membrane oxygenation (ECMO), by direct injection of autogeneic mitochondria into the ischemic myocardium.

Conditions

Extracorporeal Membrane Oxygenation Complication

Study ID

NCT02851758

Start date

Aug 2, 2017

Status verified date

Dec, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

16 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Autologous mitochondria injection

All subjects will have autologous mitochondria injected into ischemic areas of the myocardium (via injection or infusion).

Interventions

autologous mitochondria transplantation

Autologous mitochondria obtained from the subject's own skeletal muscle will be injected or infused into the ischemic myocardium

Primary outcome measure

  • Safety- Incidence of severe adverse events [ Time Frame: 1 week ]

Central Contacts and Locations

Central contacts

Breanna Piekarski, RN, BSN

617-919-4457breanna.piekarski@cardio.chboston.org

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Breanna Piekarski, RN, BSN

617-919-4457breanna.piekarski@cardio.chboston.org

Principal Investigator:

Sitaram M Emani, MD

More Information

Sponsor

Boston Children's Hospital

Last update posted

Jan 5, 2026

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-01-05.