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Blood and skin samples could unlock new mitochondrial disease treatments

NCT ID NCT06474104

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study collects blood and skin samples from 100 people with primary mitochondrial diseases and healthy volunteers aged 3 to 85. Researchers will study how different mitochondrial mutations affect cell function and look for biomarkers. The samples will also help test a new therapy called mitochondrial augmentation technology (MAT).

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help researchers develop a new therapy called mitochondrial augmentation technology (MAT) for mitochondrial diseases.
What could go wrong
This is an early-stage sample collection study, not a treatment trial. It may not lead to an effective therapy, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Samples of peripheral blood will be collected from up to 50 patients with PMD and up to 50 healthy volunteers. Samples of skin will be collected from up to 50 patients with PMD.

Ages

3 to 85 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female, age 3 to 85 years. 2. For patients with Primary Mitochondrial Disease: a. Clinical diagnosis of PMD confirmed by mtDNA sequencing. 3. For Healthy Volunteers: 1. Normal Vital signs and BMI for age 2. No active medical conditions or diseases 3. No current medications, other than acetaminophen and naproxen sodium 4. For All Subjects: 1. No viral or bacterial illness in past 2 weeks 2. No antibiotic or antiviral medications in past 2 weeks 3. No blood transfusion in past 2 weeks 4. No current pregnancy 5. Not currently breastfeeding 6. Alcohol use less than 2 drinks / day 7. No recreational or illicit drug use in previous 1 year 8. No tobacco or nicotine containing products in previous 1 year 5. Patient, parent or guardian able to understand and provide voluntary written informed consent. Exclusion Criteria: 1\. History of prior treatment with allogeneic hematopoietic stem cell transplantation, or gene therapy.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Sheba Medical Center - Tel Ashomer

    RECRUITING

    Ramat Gan, Israel, 5266202, Israel