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Nano-ink gel could replace repeated skull surgeries for kids with rare genetic disorders

NCT ID NCT07535372

Disease control Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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

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This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

This early-stage study aims to develop a personalized treatment for children with syndromic craniosynostosis, a group of rare genetic disorders where skull bones fuse too early. The approach uses a nano-engineered gel to deliver custom genetic medicine directly to the affected area, potentially reducing the need for repeated surgeries. The study involves 12 children aged 0-5 years and will first test the treatment in lab-grown cells and mouse models.

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Study facts

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

Participants

About 12 people

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

Started

Apr 2026

Expected to finish

Apr 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

Prospective and retrospective paediatric patients, undergoing/underwent corrective surgery for craniosynostosis as per standard of care, will be enrolled at Policlinico Gemelli upon obtain a written informed consent by their parents/legal guardians. Patient selection will be based on genetic evaluations from prior testing conducted as part of their clinical management. A total of 12 patients, with confirmed genetic diagnosis of SCS, with at least 4 different disease-causing mutations, will be selected for the study and cells isolated from their suture samples (surgical waste) analysed.

Ages

Up to 5 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Paediatric patients (0-5 years), with a confirmed genetic diagnosis of syndromic craniosynostosis involving pathogenic GoF or LoF variants in FGFR1-3, TWIST1, TCF12, EFNB1, ERF, MSX2, or ALX4. * Availability of cranial-suture tissue fragments obtained during surgical remodelling procedures and classified as surgical waste. * Signed informed consent from parents or legal guardians. Exclusion Criteria: * Patients older than 5 years. * Patients aged 0-5 years with conditions unrelated to syndromic craniosynostosis in the selected genes. * Genetic variants of uncertain significance or undetermined molecular diagnosis. * Tissue samples with insufficient quantity or inadequate quality for cell isolation or culture. * Refusal of informed consent.

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Conditions

The condition(s) this trial relates to.

Apert syndrome craniofrontonasal syndrome craniosynostosis Crouzon syndrome Muenke syndrome Pfeiffer syndrome Saethre-Chotzen syndrome syndromic craniosynostosis

As listed by the trial registrant

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

Apert syndrome Craniosynostoses Crouzon syndrome Muenke syndrome Pfeiffer syndrome Saethre chotzen syndrome

How to take part

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  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

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Contacts and locations

Locations

  • Cellular and Experimental Biology Unit

    RECRUITING

    Rome, 00168, Italy

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