NCT02851758

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Aug 2017Jun 2027

First Submitted

Initial submission to the registry

July 25, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
1 year until next milestone

Study Start

First participant enrolled

August 2, 2017

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

9.8 years

First QC Date

July 25, 2016

Last Update Submit

December 30, 2025

Conditions

Extracorporeal Membrane Oxygenation Complication

Outcome Measures

Primary Outcomes (1)

  • Safety- Incidence of severe adverse events

    Subjects will be SAE free for one week following injection

    1 week

Secondary Outcomes (2)

  • Efficacy- Improvement in Outcome measures: increased ventricular function on echocardiogram, measured by ejection fraction

    1 week- 1 month

  • Efficacy- Improvement in Outcome measures: ability to be separated from ECMO support, measured in days since injection

    1 week- 1 month

Study Arms (1)

Autologous mitochondria injection

EXPERIMENTAL

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

Other: autologous mitochondria transplantation

Interventions

autologous mitochondria transplantationOTHER

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

Autologous mitochondria injection

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Pediatric cardiology patients under the age of 18 on ECMO
  • concerns for ischemic injury on the Cardiac Intensive Care Unit

You may not qualify if:

  • Known mitochondria disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Study Officials

  • Sitaram M Emani, MD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Breanna Piekarski, RN, BSN

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 25, 2016

First Posted

August 2, 2016

Study Start

August 2, 2017

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

January 5, 2026

Record last verified: 2025-12

Locations

US(1)