Validation of Nanosensor Oxygen Measurement

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChildren's Hospital of Philadelphia

About this trial

Past mitochondrial disease treatment studies have been unsuccessful in determining treatment efficacy, and a major factor has been the lack of validated biomarkers in mitochondrial myopathy (MM). There is currently a growing number of potential new treatments to be tested through MM clinical intervention trials, which has created a pressing need for quantitative biomarkers that reliably reflect MM disease severity, progression, and therapeutic response. The purpose of the study is to measure the efficacy of an electrochemical oxygen nanosensor to measure in vivo mitochondrial function in human muscle tissue, and its ability to discriminate MM patients from healthy volunteers. The data and results from this nanosensor study may contribute to current and future research, including improved diagnostic and therapeutic approaches for patients with mitochondrial disease.

Eligibility criteria

Qualifiers

Inclusion Criteria for Healthy Controls

Males and females, between the ages of 18 and 65 years, inclusive

Provide informed consent for study participation; able to understand and complete the protocol

Able to ambulate independently

Disqualifiers

Unable to provide informed consent and complete all study procedures, including ergometry

Non-ambulatory or unable to ambulate independently

Pregnant

Within 1 month of a recent hospital admission due to acute illness

Trial design

Treatments tested in this trial

  • Nanosensor

Treatment groups

96 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Children's Hospital of Philadelphia

Lead sponsor

United States Department of Defense

Collaborator