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

NCT ID: NCT06910384

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-12

Study Completion Date

2025-12-16

Brief Summary

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

Detailed Description

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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.

Conditions

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Amyotrophic Lateral Sclerosis

Keywords

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ALS

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open Label
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm, Open Label

Group Type OTHER

STR04

Intervention Type BIOLOGICAL

autologous bone-marrow-derived mesenchymal stem cells

Interventions

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STR04

autologous bone-marrow-derived mesenchymal stem cells

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* "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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New England Cell Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alan Jacobs, MD, PhD

Role: STUDY_DIRECTOR

New England Cell Therapeutics, Inc.

Locations

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National Neuromuscular Research Institute

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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NECT 24-03

Identifier Type: -

Identifier Source: org_study_id