Safety of Cultured Allogeneic Adult Umbilical Cord Derive... | NCT05003921

Studies
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intrathecal Injection for ALS

NCT05003921

Sponsor

The Foundation for Orthopaedics and Regenerative Medicine

Status

Suspended

Last Update Posted

Apr 17, 2025Actual

Enrollment

20Estimated

Phase

Phase 1

Conditions

Amyotrophic Lateral Sclerosis

Interventions

AlloRx

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

Apr 2025

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Modifying Protocol

Expanded Access Info

Start Date

Dec 2025Estimated

Primary Completion Date

Sep 2028Estimated

Completion Date

Sep 2028Estimated

First Submitted Date

Aug 6, 2021

First Submission Date that Met QC Criteria

Aug 6, 2021

First Posted Date

Aug 13, 2021Actual

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

Apr 15, 2025

Last Update Posted Date

Apr 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This trial will study the safety and efficacy of intrathecal injection of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of amyotrophic lateral sclerosis

Detailed Description

Amyotrophic lateral sclerosis is a devastating disease. There is evidence that mesenchymal stem cell treatment is safe and can improve the prognosis of afflicted patients. Patients with ALS will receive three intrathecal injections of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. The dose for each injection will be 50 million cells and the injections will be at two-month intervals. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment Group	Experimental	three intrathecal injections of 50 million cells at two-month intervals.	Biological: AlloRx

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AlloRx	Biological	cultured allogeneic adult umbilical cord derived mesenchymal stem cells	Treatment Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety (adverse events)	Clinical monitoring of possible adverse events or complications	Four year follow-up

Secondary Outcomes

Measure	Description	Time Frame
Efficacy: revised ALS functional rating scale (ALSFRS-R)	ALSFRS-R scale is used to evaluate the progression of disability in patients with ALS. It will be completed for each follow up point.	Four year follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of Amyotrophic Lateral Sclerosis.
Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

Active infection
Active cancer
Chronic multisystem organ failure
Pregnancy
Anticoagulation medicine use
Clinically significant Abnormalities on pre-treatment laboratory evaluation
Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
Previous organ transplant
Hypersensitivity to sulfur
Continued drug abuse
Pre-menopausal women not using contraception

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chadwick Prodromos, MD	The Foundation for Orthopaedics and Regenerative Medicine	Principal Investigator

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
10540002	Background	Cedarbaum JM, Stambler N, Malta E, Fuller C, Hilt D, Thurmond B, Nakanishi A. The ALSFRS-R: a revised ALS functional rating scale that incorporates assessments of respiratory function. BDNF ALS Study Group (Phase III). J Neurol Sci. 1999 Oct 31;169(1-2):13-21. doi: 10.1016/s0022-510x(99)00210-5.
26751635	Background

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D016472	Motor Neuron Disease