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Mitochondrial Therapy

Mitochondria Transplantation for Heart Ischemia

N/A
Recruiting
Led By Sitaram M Emani, MD
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with concerns for ischemic injury on the Cardiac Intensive Care Unit
Pediatric cardiology patients under the age of 18 on ECMO
Must not have
Known mitochondria disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week- 1 month
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether injecting healthy mitochondria into an ischemic (restricted blood flow) heart can decrease morbidity and mortality.

Who is the study for?
This trial is for pediatric cardiology patients under 18 years old who are on ECMO (a life support machine) and have concerns about heart muscle damage due to poor blood flow. It's not open to those with known mitochondrial disorders.
What is being tested?
The study is testing a new procedure where mitochondria, the energy-producing parts of cells, are taken from the patient's own body and injected into their heart muscle that has been damaged by poor blood flow.
What are the potential side effects?
Since this is an experimental procedure, specific side effects aren't fully known but may include typical risks associated with injections such as pain at injection site, infection risk, or immune response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am in the ICU for heart-related issues.
Select...
My child is under 18 and on ECMO for heart support.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a diagnosed mitochondrial disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week- 1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week- 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety- Incidence of severe adverse events
Secondary study objectives
Efficacy- Improvement in Outcome measures: ability to be separated from ECMO support, measured in days since injection
Efficacy- Improvement in Outcome measures: increased ventricular function on echocardiogram, measured by ejection fraction

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Autologous mitochondria injectionExperimental Treatment1 Intervention
All subjects will have autologous mitochondria injected into ischemic areas of the myocardium (via injection or infusion).

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
789 Previous Clinical Trials
5,582,931 Total Patients Enrolled
Sitaram M Emani, MDPrincipal InvestigatorBoston Children's Hospital
1 Previous Clinical Trials
19 Total Patients Enrolled

Media Library

Autologous Mitochondria Transplantation (Mitochondrial Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02851758 — N/A
Extracorporeal Membrane Oxygenation Research Study Groups: Autologous mitochondria injection
Extracorporeal Membrane Oxygenation Clinical Trial 2023: Autologous Mitochondria Transplantation Highlights & Side Effects. Trial Name: NCT02851758 — N/A
Autologous Mitochondria Transplantation (Mitochondrial Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02851758 — N/A
~2 spots leftby Dec 2025
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