NCT07105371

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2024

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 14, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 5, 2025

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

8 months

First QC Date

July 22, 2025

Last Update Submit

August 18, 2025

Conditions

Motor Disorders

Keywords

exosomessecretomeALSKennedy diseaseCongenital Myasthenic SyndromeLewy body dementia

Outcome Measures

Primary Outcomes (1)

  • ALSFRS-R Results

    from enrollment until 6 months after treatment

Study Arms (1)

Treatment Group (AlloEx)

EXPERIMENTAL
Biological: AlloEx exosomes

Interventions

AlloEx exosomesBIOLOGICAL

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

Treatment Group (AlloEx)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Surgical Associates Center

St John's, Antigua and Barbuda

Location

Related Publications (1)

  • Prodromos CC, Del Villar R, Jin MY, Abd-Elsayed A, Candido K. Exosome-rich mesenchymal stem cell secretome improves strength in patients with amyotrophic lateral sclerosis, Kennedy disease, congenital myasthenic syndrome and Lewy body dementia. Am J Stem Cells. 2025 Oct 15;14(4):217-229. doi: 10.62347/FTXA8845. eCollection 2025.

    PMID: 41278139DERIVED

MeSH Terms

Conditions

Motor DisordersBulbo-Spinal Atrophy, X-LinkedMyasthenic Syndromes, CongenitalLewy Body Disease

Condition Hierarchy (Ancestors)

Mental DisordersMuscular Atrophy, SpinalSpinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesMotor Neuron DiseaseNeuromuscular DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeuromuscular Junction DiseasesParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesDementiaMovement DisordersSynucleinopathiesNeurocognitive Disorders

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2025

First Posted

August 5, 2025

Study Start

July 14, 2024

Primary Completion

March 14, 2025

Study Completion

March 14, 2025

Last Updated

August 22, 2025

Record last verified: 2025-08

Locations

AN(1)