Extracorporeal Membrane Oxygenation ComplicationNCT02851758
Transplantation of Autologously Derived Mitochondria Following Ischemia
A study testing autologous mitochondria transplantation in people with Extracorporeal Membrane Oxygenation Complication, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Extracorporeal Membrane Oxygenation Complication
- What is being tested?
- autologous mitochondria transplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2017to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric cardiology patients under the age of 18 on ECMO
- concerns for ischemic injury on the Cardiac Intensive Care Unit
Who cannot join
- Known mitochondria disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Breanna Piekarski, RN, BSN, 617-919-4457, breanna.piekarski@cardio.chboston.org
Sitaram M Emani, MD
About this study
Official title: Transplantation of Autologously Derived Mitochondria for Protection Against Ischemia-reperfusion Injury Following Ischemia in Subjects on ECMO Support
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.
Read the detailed description
Autologous mitochondria will be delivered to the ischemic heart muscle in one of two ways, during clinically indicated surgical procedure or during clinically indicated cardiac catheterization.
For surgical re-operation subjects:
After the subject's chest is open, 1-2 6mm biopsies will be collected from the exposed skeletal muscle of the chest wall. The tissue will be processed at bedside to extract the autologous mitochondria. Surgery will proceed as clinically indicated. Prior to closure of the chest, autologous mitochondria will be injected via 5-10 injections of approximately 0.1 mL each to the damaged area (if damaged muscle is local) or via injection into the proximal aorta while cross-clamped for clinically indicated surgery for global distribution of mitochondria via the coronary arteries if there is no evident area of damage. Following completion of surgical maneuvers the mitochondria will be injected into the aorta and the cross-clamp will be removed. If there is global injury but a cross-clamp is not clinically indicated, direct injection into the myocardium will occur throughout the ventricle as previously described. Chest closure will then occur as and if clinically indicated for both techniques.
For catheterization subjects:
Once in the catheterization lab, the temporary chest closure will be removed and 1-2 6 mm biopsies will be collected from the exposed skeletal muscle of the chest wall by the cardiac surgery team. The tissue will be processed at bedside to extract the autologous mitochondria. The catheterization will proceed as clinically indicated. Prior to completion of the procedure (interventional to restore blood flow or hemodynamics), mitochondria will be infused in 5 mL of buffer as conducted in large animal studies (5) via intracoronary infusion followed by a 5 mL flush with normal saline. Total dose of mitochondria will be equal to direct injection subjects, with a larger dilution to allow to infusion via cardiac catheter.
If there is no marked improvement in ventricular function following the injection/infusion of autologous mitochondria and the subject has a clinically indicated procedure in the days following the initial delivery, a second injection/infusion will be completed. At this time the follow up schedule will be reset to Day 0.
- Being tested
- autologous mitochondria transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous mitochondria transplantationOther
Autologous mitochondria obtained from the subject's own skeletal muscle will be injected or infused into the ischemic myocardium
| Study group | Role | What they receive |
|---|---|---|
| Autologous mitochondria injection | Experimental | All subjects will have autologous mitochondria injected into ischemic areas of the myocardium (via injection or infusion). Receives: Other: autologous mitochondria transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety- Incidence of severe adverse events
Subjects will be SAE free for one week following injection
Measured: 1 week
Secondary outcomes (2)
Efficacy- Improvement in Outcome measures: increased ventricular function on echocardiogram, measured by ejection fraction
Improvement in ventricular function
Measured: 1 week- 1 month
Efficacy- Improvement in Outcome measures: ability to be separated from ECMO support, measured in days since injection
The ability to decannulate from ECMO support
Measured: 1 week- 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study start2 Aug 2017
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extracorporeal Membrane Oxygenation ComplicationStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sitaram Emani, Boston Children's Hospital
- Investigators
- Sitaram M Emani, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851758
- Sponsor's protocol ID
- IRB-P00014558
- Status last verified
- Dec 2025
- First submitted
- 25 Jul 2016
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Suh J, Lee YS. Mitochondria as secretory organelles and therapeutic cargos. Exp Mol Med. 2024 Feb;56(1):66-85. doi: 10.1038/s12276-023-01141-7. Epub 2024 Jan 4.
PubMed 38172601
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transplantation of Autologously Derived Mitochondria for Protection Against Ischemia-reperfusion Injury Following Ischemia in Subjects on ECMO Support
- ClinicalTrials.gov ID
- NCT02851758
- Acronym / sponsor ID
- IRB-P00014558
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 2 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Autologous mitochondria will be delivered to the ischemic heart muscle in one of two ways, during clinically indicated surgical procedure or during clinically indicated cardiac catheterization.
For surgical re-operation subjects:
After the subject's chest is open, 1-2 6mm biopsies will be collected from the exposed skeletal muscle of the chest wall. The tissue will be processed at bedside to extract the autologous mitochondria. Surgery will proceed as clinically indicated. Prior to closure of the chest, autologous mitochondria will be injected via 5-10 injections of approximately 0.1 mL each to the damaged area (if damaged muscle is local) or via injection into the proximal aorta while cross-clamped for clinically indicated surgery for global distribution of mitochondria via the coronary arteries if there is no evident area of damage. Following completion of surgical maneuvers the mitochondria will be injected into the aorta and the cross-clamp will be removed. If there is global injury but a cross-clamp is not clinically indicated, direct injection into the myocardium will occur throughout the ventricle as previously described. Chest closure will then occur as and if clinically indicated for both techniques.
For catheterization subjects:
Once in the catheterization lab, the temporary chest closure will be removed and 1-2 6 mm biopsies will be collected from the exposed skeletal muscle of the chest wall by the cardiac surgery team. The tissue will be processed at bedside to extract the autologous mitochondria. The catheterization will proceed as clinically indicated. Prior to completion of the procedure (interventional to restore blood flow or hemodynamics), mitochondria will be infused in 5 mL of buffer as conducted in large animal studies (5) via intracoronary infusion followed by a 5 mL flush with normal saline. Total dose of mitochondria will be equal to direct injection subjects, with a larger dilution to allow to infusion via cardiac catheter.
If there is no marked improvement in ventricular function following the injection/infusion of autologous mitochondria and the subject has a clinically indicated procedure in the days following the initial delivery, a second injection/infusion will be completed. At this time the follow up schedule will be reset to Day 0.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous mitochondria injection | Experimental | Other: autologous mitochondria transplantationAll subjects will have autologous mitochondria injected into ischemic areas of the myocardium (via injection or infusion). |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Pediatric cardiology patients under the age of 18 on ECMO
- concerns for ischemic injury on the Cardiac Intensive Care Unit
Key exclusion criteria (1 listed)
- Known mitochondria disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous mitochondria transplantationAutologous mitochondria obtained from the subject's own skeletal muscle will be injected or infused into the ischemic myocardium | Other | Autologous mitochondria injection |
Primary outcome
Safety- Incidence of severe adverse events
Time frame: 1 week
Subjects will be SAE free for one week following injection
2 secondary outcomes
Efficacy- Improvement in Outcome measures: increased ventricular function on echocardiogram, measured by ejection fraction
Time frame: 1 week- 1 month
Efficacy- Improvement in Outcome measures: ability to be separated from ECMO support, measured in days since injection
Time frame: 1 week- 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Derived from this study: PubMed 38172601Suh J, Lee YS. Mitochondria as secretory organelles and therapeutic cargos. Exp Mol Med. 2024 Feb;56(1):66-85. doi: 10.1038/s12276-023-01141-7. Epub 2024 Jan 4.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sitaram M Emani, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autologous mitochondria transplantation in people with Extracorporeal Membrane Oxygenation Complication, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Breanna Piekarski, RN, BSN (617-919-4457, breanna.piekarski@cardio.chboston.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety- Incidence of severe adverse events (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02851758, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.