← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week- 1 month

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week- 1 month

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety- Incidence of severe adverse events

Secondary outcome measures

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

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).

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor

761 Previous Clinical Trials

5,579,714 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is enrollment open for this investigation?

"Affirmative. According to the listings on clinicaltrials.gov, this trial has been live since August 2nd 2017 and was recently updated in October 2021. The project is hoping to source 16 participants from one medical centre."

Answered by AI

Is this research endeavor now enlisting participants?

"Affirmative. The clinicaltrials.gov website hosts information verifying that this experiment is currently recruiting volunteers, with the initial posting dating back to August 2nd 2017 and most recent update being October 4th 2021. 16 individuals are required for a single research site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transplantation of Autologously Derived Mitochondria Following Ischemia

Sitaram Emani 2017. "Transplantation of Autologously Derived Mitochondria Following Ischemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02851758.

All > Ecmo