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Miniature Nerve-Muscle models may reveal why some myasthenia gravis patients Don't improve

NCT ID NCT07717281

Knowledge-focused Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This study investigates why about 10-15% of people with generalized myasthenia gravis (MG) do not respond to standard treatments. Researchers will take blood samples from 40 adults with MG and from healthy controls, then expose lab-grown human neuromuscular organoids to antibodies from these samples. By measuring changes in the organoids' electrical activity and structure, they aim to determine if irreversible damage at the nerve-muscle junction explains treatment resistance, and to identify blood biomarkers that could predict a refractory course.

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 could identify blood tests that predict which patients will have refractory disease, and point toward new treatments that repair nerve-muscle damage.
What could go wrong
This is an early, observational study with only 40 participants. The organoid model may not fully replicate human disease, and findings may not translate to clinical practice.

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 40 people

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

Started

Jun 2026

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Adults with acetylcholine receptor antibody-positive (AChR-positive) generalized myasthenia gravis, followed at two Italian tertiary referral centers for neuromuscular diseases, stratified by disease duration and response to conventional immunosuppressive therapy into treatment-naive, treatment-sensitive, and treatment-refractory subgroups. Both patients already followed at the participating centers (retrospective component) and newly evaluated patients (prospective component) are included. A control group of adults evaluated for neurological symptoms whose diagnostic work-up excluded neuromuscular disease is enrolled at the coordinating center only. Clinical data and residual (leftover) blood samples collected during routine clinical care are analyzed.

Ages

18 years and older

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: AChR-positive MG participants (all of the following): * Age \>= 18 years * Established diagnosis of myasthenia gravis according to international criteria (fluctuating muscle weakness plus at least one of: positive anticholinesterase test; \>10% decrement on repetitive nerve stimulation \[SR-ENG\]; or increased jitter on single-fiber EMG \[SFEMG\]) * Anti-AChR antibody positivity confirmed by serological testing * Generalized MG stratified by disease duration and response to conventional immunosuppressive therapy into: treatment-naive MG (nMG); treatment-sensitive MG with stable disease and at least 12 months of follow-up (sMG); or treatment-refractory MG with at least 12 months of follow-up (rMG) * Signed informed consent (prospective component) * For the retrospective component, availability of biobanked biological samples with a signed specific informed consent Control participants (all of the following): * Age \>= 18 years * Absence of neuromuscular disease * Absence of known autoimmune disease * No ongoing immunosuppressive or immunomodulatory therapy * Negative for anti-AChR and anti-MuSK antibodies * Age- and sex-matched to the MG groups * Signed informed consent Exclusion Criteria: * Seronegative (AChR-negative) generalized MG, or MG with anti-MuSK or other non-AChR antibodies * Purely ocular myasthenia gravis * Other concomitant neuromuscular disease (e.g., Lambert-Eaton myasthenic syndrome, polymyositis, muscular dystrophies) * Pregnancy or breastfeeding * Inability to provide informed consent

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Conditions

The condition(s) this trial relates to.

myasthenia gravis

As listed by the trial registrant

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

Myasthenia gravis, generalized

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

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    RECRUITING

    Milan, 20122, Italy

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