Patients With ALS and Other Motor Disorders Will be Treated With Mesenchymal Cell Exosome Solution

Patients with ALS and other Motor Discorders will be treated with mesenchymal cell exosome solution.

Completed

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Key information

Conditions

Motor Disorders Basal Ganglia Diseases Brain Diseases Bulbo-Spinal Atrophy, X-Linked Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dementia Genetic Diseases, Inborn Genetic Diseases, X-Linked Heredodegenerative Disorders, Nervous System Lewy Body Disease Mental Disorders Motor Neuron Disease Movement Disorders Muscular Atrophy, Spinal Myasthenic Syndromes, Congenital Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Parkinsonian Disorders Spinal Cord Diseases Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medical Surgical Associates Center

St John's, Antigua and Barbuda

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients will need a diagnosis established by a neurologist. Patients must be able to provide informed consent, or have a guardian who does. They must be able to travel to the site of treatment.

Exclusion criteria

Patients were excluded from the trial if they were pregnant or had active cancer at the screening consultation.

Treatment and study plan

AlloEx exosomes

Biological

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

Primary outcomes

ALSFRS-R Results

Time frame: from enrollment until 6 months after treatment

Sponsors and collaborators

Lead sponsor

The Foundation for Orthopaedics and Regenerative Medicine

Other

Registry information

Official study title

Patients With ALS and Other Motor Discorders Will be Treated With Mesenchymal Cell Exosome Solution

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Aug 5, 2025
Registry last updated: Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed