Actively Recruiting
Mesenchymal Stem Cell Exosome Treatment of Congenital Myasthenic Syndrome
Led by The Foundation for Orthopaedics and Regenerative Medicine · Updated on 2025-11-10
20
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on patients diagnosed with Congenital Myasthenic Syndrome, aiming to evaluate the effects of a treatment using mesenchymal stem cell exosome solution. The study is a Phase 1, single-arm, non-controlled trial where patients are assessed before treatment and monitored afterward to track outcomes such as oxygen saturation over a six-month period. Participants receive an experimental intranasal treatment called AlloEx exosomes, which are derived from mesenchymal stem cells. The study involves prospective evaluation of patients, treatment administration, and follow-up assessments but does not include a control or placebo group. During the trial, participants will undergo regular monitoring from enrollment up to six months after treatment to evaluate oxygen saturation levels. The study requires patients to visit the treatment site and provide informed consent. The trial is sponsored by The Foundation for Orthopaedics and Regenerative Medicine and is designed to carefully track patient outcomes following the investigational treatment.
CONDITIONS
Brief Title
Patients With Congenital Myasthenic Syndrome Will be Treated With Mesenchymal Stem Cell Exosome Solution
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have a diagnosis of Congenital Myasthenic Syndrome by a licensed physician.
- Patients must be able to provide informed consent or have a guardian who can.
- Patients must be able to travel to the treatment site.
You will not qualify if you...
- Patients who are pregnant at the time of screening.
- Patients with active cancer (malignancy) at the screening consultation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From enrollment to 6 months after treatment
Participants receive intranasal treatment with AlloEx exosomes derived from mesenchymal stem cells.
Trial Site Locations
Total: 3 locations
1
Prodromos Stem Cell Institute
Naples, Florida, United States, 34102
Actively Recruiting
2
Prodromos Stem Cell Institute
Irving, Texas, United States, 75039
Actively Recruiting
3
Medical Surgical Associates Center
St John's, Antigua and Barbuda
Actively Recruiting
Research Team
C
Chadwick Prodromos
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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