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Can amniotic cell secretions shield nerves in ALS and MS?

NCT ID NCT06551649

Knowledge-focused Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Researchers are collecting blood and skin samples from people with ALS, people with MS, and healthy volunteers. They turn skin cells into stem cells and grow them into 3D organoids that mimic the brain and spinal cord. The goal is to see whether secretions from human amniotic mesenchymal stromal cells can protect nerves and calm inflammation in these lab models.

What this could mean

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

Active substance
human amniotic mesenchymal stromal cell secretome
What this could lead to
If the secretome protects nerve cells in these lab models, it could point toward a future treatment that both shields nerves and reduces inflammation in ALS and MS.
What could go wrong
This is a lab study using cells in dishes, not a treatment given to people. Results in organoids often fail to carry over to patients, and the small number of samples limits how much the findings can be generalised.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

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

Started

Jan 2025

Expected to finish

Feb 2027

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.

Ages

20 to 60 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: * For patients with amyotrophic lateral sclerosis (ALS): aged between 50 and 60 years and similar age of onset and duration of the disease. * For patients with multiple sclerosis (MS): with recently confirmed diagnosis of MS, aged between 20 and 50 years and considering the male-to-female ratio in MS of approximately 2:1. * For healthy volunteers: spouses of patients unaffected by any neurological disease and matching their age and gender ratio for both conditions. Exclusion Criteria: * Patients who do not consent to participate in the study. * MS patients who have received treatment with immunomodulators or corticosteroids and are in an acute phase of the disease.

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis multiple sclerosis

As listed by the trial registrant

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

Amyotrophic lateral sclerosis Multiple sclerosis

Contacts and locations

Locations

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Roma, 00168, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, 00168, Italy

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