Transplantation of Autologously Derived Mitochondria Following Ischemia

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT02851758
Status
Recruiting
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Conditions

  • Extracorporeal Membrane Oxygenation Complication

Eligibility Criteria

Sex
ALL
Age
N/A - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • autologous mitochondria transplantation — OTHER
    Autologous mitochondria obtained from the subject's own skeletal muscle will be injected or infused into the ischemic myocardium

Study Details

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.

Key Dates

Start date
Aug 2, 2017
Status verified
Dec 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
Breanna Piekarski, RN, BSN
[email protected]
617-919-4457
Sitaram M Emani, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Boston Children's Hospital· Boston, MA

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