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Transplantation of Autologously Derived Mitochondria Following Ischemia

Primary Purpose

Extracorporeal Membrane Oxygenation Complication

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
autologous mitochondria transplantation
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extracorporeal Membrane Oxygenation Complication

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous mitochondria injection

Arm Description

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

Outcomes

Primary Outcome Measures

Safety- Incidence of severe adverse events
Subjects will be SAE free for one week following injection

Secondary Outcome Measures

Efficacy- Improvement in Outcome measures: increased ventricular function on echocardiogram, measured by ejection fraction
Improvement in ventricular function
Efficacy- Improvement in Outcome measures: ability to be separated from ECMO support, measured in days since injection
The ability to decannulate from ECMO support

Full Information

First Posted
July 25, 2016
Last Updated
January 9, 2023
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02851758
Brief Title
Transplantation of Autologously Derived Mitochondria Following Ischemia
Official Title
Transplantation of Autologously Derived Mitochondria for Protection Against Ischemia-reperfusion Injury Following Ischemia in Subjects on ECMO Support
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2017 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extracorporeal Membrane Oxygenation Complication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Autologous mitochondria injection
Arm Type
Experimental
Arm Description
All subjects will have autologous mitochondria injected into ischemic areas of the myocardium (via injection or infusion).
Intervention Type
Other
Intervention Name(s)
autologous mitochondria transplantation
Intervention Description
Autologous mitochondria obtained from the subject's own skeletal muscle will be injected or infused into the ischemic myocardium
Primary Outcome Measure Information:
Title
Safety- Incidence of severe adverse events
Description
Subjects will be SAE free for one week following injection
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Efficacy- Improvement in Outcome measures: increased ventricular function on echocardiogram, measured by ejection fraction
Description
Improvement in ventricular function
Time Frame
1 week- 1 month
Title
Efficacy- Improvement in Outcome measures: ability to be separated from ECMO support, measured in days since injection
Description
The ability to decannulate from ECMO support
Time Frame
1 week- 1 month

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Breanna Piekarski, RN, BSN
Phone
617-919-4457
Email
breanna.piekarski@cardio.chboston.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sitaram M Emani, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Breanna Piekarski, RN, BSN
Phone
617-919-4457
Email
breanna.piekarski@cardio.chboston.org
First Name & Middle Initial & Last Name & Degree
Sitaram M Emani, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Transplantation of Autologously Derived Mitochondria Following Ischemia

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