Transplantation of Autologously Derived Mitochondria Following Ischemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 17
SponsorBoston Children's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pediatric cardiology patients under the age of 18 on ECMO
concerns for ischemic injury on the Cardiac Intensive Care Unit
Disqualifiers
Known mitochondria disorders
Trial design
Design model
Single group
Treatments tested in this trial
autologous mitochondria transplantation
Other interventionAutologous mitochondria obtained from the subject's own skeletal muscle will be injected or infused into the ischemic myocardium
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: Autologous mitochondria injectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety- Incidence of severe adverse events
Subjects will be SAE free for one week following injection
Time frame
1 weekSecondary outcomes
1
Efficacy- Improvement in Outcome measures: increased ventricular function on echocardiogram, measured by ejection fraction
Improvement in ventricular function
Time frame
1 week- 1 month2
Efficacy- Improvement in Outcome measures: ability to be separated from ECMO support, measured in days since injection
The ability to decannulate from ECMO support
Time frame
1 week- 1 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov