Amyotrophic Lateral SclerosisPhase 2NCT06910384
A Study of STRO4 in Patients Amyotrophic Lateral Sclerosis (ALS)
A Phase 2 study testing STR04 in people with Amyotrophic Lateral Sclerosis, run by New England Cell Therapeutics, Inc. at 1 site in United States.
Trial summary
This study intends to evaluate the safety and efficacy of STR04 administered intravenously in participants with Amyotrophic Lateral Sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- STR04
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2025to 16 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- "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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Neuromuscular Research Institute
Austin, Texas, 78759
About this study
Official title: An Open Label Study of STR04 in Participants With Amyotrophic Lateral Sclerosis
This study intends to evaluate the safety and efficacy of STR04 administered intravenously in participants with Amyotrophic Lateral Sclerosis.
Read the 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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- STR04
- Keywords
- ALS
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STR04Biological
autologous bone-marrow-derived mesenchymal stem cells
| Study group | Role | What they receive |
|---|---|---|
| Single Arm, Open Label | Other | Not described Receives: Biological: STR04 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Amyotrophic Lateral Sclerosis Functional Rating Scale Score
Measured: 25 weeks
Secondary outcomes (5)
Change in Amyotrophic Lateral Sclerosis Functional Rating Scale Score
Measured: 49 weeks
Change in Percent-predicted forced vital capacity (%FVC)
Measured: From Baseline to 25 weeks and 49 weeks
Change in Manual Muscle Test (MMT)
Measured: From Baseline to 25 weeks and 49 weeks
Change in Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40)
Measured: From Baseline to 25 weeks and 49 weeks
Change in plasma neurofilament light (NfL)
Measured: From Baseline to 25 weeks and 49 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start12 Aug 2025
- Primary completion16 Dec 2025
- Study completion16 Dec 2025
Why it stopped: organizational restructure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open Label
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- New England Cell Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan Jacobs, MD, PhD, Study director, New England Cell Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910384
- Sponsor's protocol ID
- NECT 24-03
- Status last verified
- Dec 2025
- First submitted
- 7 Mar 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study of STR04 in Participants With Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT06910384
- Acronym / sponsor ID
- NECT 24-03
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- ALS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: organizational restructure
- Enrolment
- 1 participants (actual)
- Lead sponsor
- New England Cell Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 16 Dec 2025 (actual)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Label
| Arm | Type | Receives |
|---|---|---|
| Single Arm, Open Label | Other | Biological: STR04 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- "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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STR04autologous bone-marrow-derived mesenchymal stem cells | Biological | Single Arm, Open Label |
Primary outcome
Change in Amyotrophic Lateral Sclerosis Functional Rating Scale Score
Time frame: 25 weeks
5 secondary outcomes
Change in Amyotrophic Lateral Sclerosis Functional Rating Scale Score
Time frame: 49 weeks
Change in Percent-predicted forced vital capacity (%FVC)
Time frame: From Baseline to 25 weeks and 49 weeks
Change in Manual Muscle Test (MMT)
Time frame: From Baseline to 25 weeks and 49 weeks
Change in Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40)
Time frame: From Baseline to 25 weeks and 49 weeks
Change in plasma neurofilament light (NfL)
Time frame: From Baseline to 25 weeks and 49 weeks
Results and safety
The study was stopped early (reason given: organizational restructure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Jacobs, MD, PhD study director
New England Cell Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing STR04 in people with Amyotrophic Lateral Sclerosis, run by New England Cell Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: organizational restructure). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Amyotrophic Lateral Sclerosis Functional Rating Scale Score (time frame: 25 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.