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Patients With Congenital Myasthenic Syndrome Will be Treated With Mesenchymal Stem Cell Exosome Solution

NCT ID: NCT07226726

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2028-12-31

Brief Summary

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Patients with Congenital Myasthenic Syndrome will be treated with Mesenchymal Stem Cell Exosome solution.

Detailed Description

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Single Arm non-controlled study. Patients are prospectively evaluated then treated. Outcomes are tracked after treatment.

Conditions

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Congenital Myasthenic Syndrome

Keywords

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exosomes secretome Congenital Myasthenic Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Group

Group Type EXPERIMENTAL

AlloEx exosomes

Intervention Type BIOLOGICAL

This is an intranasal treatment of exosomes derived from mesenchymal stem cells.

Interventions

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AlloEx exosomes

This is an intranasal treatment of exosomes derived from mesenchymal stem cells.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patients will need a diagnosis of Congenital Myasthenic Syndrome by a licensed physician.
* Patients must be able to provide informed consent, or have a guardian who does.
* Patient must be able to travel to the site of treatment.

Exclusion Criteria

* Patients will be excluded from the trial if they are pregnant or have active cancer (malignancy) at the screening consultation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Foundation for Orthopaedics and Regenerative Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Prodromos Stem Cell Institute

Naples, Florida, United States

Site Status RECRUITING

Prodromos Stem Cell Institute

Irving, Texas, United States

Site Status RECRUITING

Medical Surgical Associates Center

St John's, , Antigua and Barbuda

Site Status RECRUITING

Countries

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United States Antigua and Barbuda

Central Contacts

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Chadwick Prodromos

Role: CONTACT

Phone: 18476996810

Email: [email protected]

Facility Contacts

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Chadwick Prodromos, MD

Role: primary

Chadwick Prodromos, MD

Role: primary

Chadwick Prodromos, MD

Role: primary

Other Identifiers

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FOREM2025-CMS1

Identifier Type: -

Identifier Source: org_study_id