Recruiting
Phase 1

Mesenchymal Stem Cells

Sponsor:

The Foundation for Orthopaedics and Regenerative Medicine

Code:

NCT07226726

Conditions

Congenital Myasthenic Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AlloEx exosomes

Study Details

Brief summary:

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

Conditions

Congenital Myasthenic Syndrome

Study ID

NCT07226726

Start date

Jan 1, 2025

Status verified date

Nov, 2025

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Group

Interventions

AlloEx exosomes

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

Primary outcome measure

  • Oxygen Saturation [ Time Frame: From enrollment to 6 months after treatment ]

Central Contacts and Locations

Central contacts

Chadwick Prodromos

18476996810care@thepsci.com

Locations

Prodromos Stem Cell Institute

Recruiting

Naples, Florida, United States, 34102

Contacts

Chadwick Prodromos, MD

847-699-6810care@thepsci.com

Prodromos Stem Cell Institute

Recruiting

Irving, Texas, United States, 75039

Contacts

Chadwick Prodromos, MD

847-699-6810care@thepsci.com

More Information

Sponsor

The Foundation for Orthopaedics and Regenerative Medicine

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Keywords

  • exosomes
  • secretome
  • Congenital Myasthenic Syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Foundation for Orthopaedics and Regenerative Medicine on 2025-11-10.