Patients With ALS and Other Motor Disorders Will be Treat... | NCT07105371

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

NCT07105371

Sponsor

The Foundation for Orthopaedics and Regenerative Medicine

Status

Completed

Last Update Posted

Aug 22, 2025Actual

Enrollment

18Actual

Phase

Phase 1

Conditions

Motor Disorders

Interventions

AlloEx exosomes

Countries

Antigua and Barbuda

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 14, 2024Actual

Primary Completion Date

Mar 14, 2025Actual

Completion Date

Mar 14, 2025Actual

First Submitted Date

Jul 22, 2025

First Submission Date that Met QC Criteria

Jul 29, 2025

First Posted Date

Aug 5, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2025

Last Update Posted Date

Aug 22, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment Group (AlloEx)	Experimental		Biological: AlloEx exosomes

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AlloEx exosomes	Biological	This is an intranasal treatment of exosomes derived from mesenchymal stem cells.	Treatment Group (AlloEx)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ALSFRS-R Results		from enrollment until 6 months after treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Surgical Associates Center		St John's			Antigua and Barbuda

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41278139	Derived	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.

ID	Term
D000068079	Motor Disorders
D055534	Bulbo-Spinal Atrophy, X-Linked
D020294	Myasthenic Syndromes, Congenital
D020961	Lewy Body Disease

ID	Term
D001523	Mental Disorders
D009134	Muscular Atrophy, Spinal
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases