A Study of STRO4 in Patients Amyotrophic Lateral Sclerosi... | NCT06910384

Studies
A Study of STRO4 in Patients Amyotrophic Lateral Sclerosis (ALS)

NCT06910384

Sponsor

New England Cell Therapeutics, Inc.

Status

Terminated

Last Update Posted

Dec 18, 2025Actual

Enrollment

1Actual

Phase

Phase 2

Conditions

Amyotrophic Lateral Sclerosis

Interventions

STR04

Countries

United States

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

Dec 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

organizational restructure

Expanded Access Info

Start Date

Aug 12, 2025Actual

Primary Completion Date

Dec 16, 2025Actual

Completion Date

Dec 16, 2025Actual

First Submitted Date

Mar 7, 2025

First Submission Date that Met QC Criteria

Mar 27, 2025

First Posted Date

Apr 4, 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

Dec 16, 2025

Last Update Posted Date

Dec 18, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study intends to evaluate the safety and efficacy of STR04 administered intravenously in participants with Amyotrophic Lateral Sclerosis.

Detailed Description

This study is a 69 week open label study of autologous bone-marrow-derived mesenchymal stem cells (STR04) in participants with ALS.

Participants will undergo a screening visit, followed by collection of peripheral blood and bone marrow for the manufacture of STR04. Once manufacturing is successfully completed, participants will have a Baseline visit followed by 4 doses of STR04, one dose every 12 weeks. Participants will have a final assessments 12 weeks after the 4th dose.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Label	Type	Description	Intervention Names
Single Arm, Open Label	Other		Biological: STR04

Name	Type	Description	Arm Group Labels	Other Names
STR04	Biological	autologous bone-marrow-derived mesenchymal stem cells	Single Arm, Open Label

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Amyotrophic Lateral Sclerosis Functional Rating Scale Score		25 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in Amyotrophic Lateral Sclerosis Functional Rating Scale Score		49 weeks
Change in Percent-predicted forced vital capacity (%FVC)		From Baseline to 25 weeks and 49 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion:

"Definite" or "Probable" ALS according to the Revised El Escorial criteria (Airlie House)
ALS severity grade 1 or 2 according to the Japan ALS severity classification.
ALSFRS-R scores of 2 or more for all items, with scores of 4 for all breathing- related items (i.e., dyspnea, orthopnea, respiratory insufficiency).
Within 2 years of ALS onset.
%FVC of 80% or more.
Aged 18 to ≤75 years at the time of informed consent.

Exclusion:

Current Viral Infection (e.g. HBV, HCV, HIV, HTLV-1, HPVB19, syphilis, COVID- 19).
Current low blood cell counts
History of cancer, congenital malformations, or chromosomal abnormalities
History of allergy to penicillin or streptomycin, or other serious allergies.
Current poor medical condition, due to endocrine disease, metabolic disease, immune disease, blood disease, psychiatric disorders, neurological diseases, cardiovascular diseases, respiratory diseases, gastrointestinal diseases, musculoskeletal or connective tissue diseases, renal or urogenital diseases.
History of intracranial lesions, or stenosis, dissection or severe atherosclerotic disease of a blood vessel in the head or neck.
Current uncontrolled hypertension.
Prior treatment with a cell or gene therapy.
Currently participating in any other clinical trial.
Women who are pregnant, breastfeeding, or plan to become pregnant during study participation
Men with plan for their partner to become pregnant during study participation.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Alan Jacobs, MD, PhD	New England Cell Therapeutics, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
National Neuromuscular Research Institute		Austin	Texas	78759	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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