Amyotrophic Lateral Sclerosis (ALS)NCT07143656
Amyotrophic Lateral Sclerosis: A Multicenter Retrospective Observational Registry
An observational study of Amyotrophic Lateral Sclerosis (ALS) and Amyotrophic Lateral Sclerosis &Amp; Other Neuromuscular Disorders, run by Biocells Medical at 1 site in Poland.
Trial summary
This retrospective observational study will analyze de-identified clinical data from patients with amyotrophic lateral sclerosis (ALS) collected at multiple centers over 7 years. The primary objective is to describe disease progression using the ALS Functional Rating Scale-Revised (ALSFRS-R). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (ALS), Amyotrophic Lateral Sclerosis &Amp; Other Neuromuscular Disorders
- What is being tested?
- Imaging and Clinical Reports
- How many people
- 36 participants
- Where
- 1 sitePoland
- Study dates
- 13 May 2021to 1 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People aged ≥18 with ALS
Who may be able to join
- Diagnosis of amyotrophic lateral sclerosis (ALS) or motor neuron disease confirmed.
- Age ≥18 years.
- Availability of at least one ALS Functional Rating Scale-Revised (ALSFRS-R) score.
- Availability of longitudinal follow-up data.
Who cannot join
- Patients with alternative diagnoses that mimic ALS (e.g., multifocal motor neuropathy, cervical myelopathy, myasthenia gravis).
- Absence of medical records
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Natural History and Biomarker Correlation Study in Amyotrophic Lateral Sclerosis: A Multicenter Retrospective Observational Registry
This retrospective observational study will analyze de-identified clinical data from patients with amyotrophic lateral sclerosis (ALS) collected at multiple centers over 7 years. The primary objective is to describe disease progression using the ALS Functional Rating Scale-Revised (ALSFRS-R). Secondary objectives include evaluating survival, ventilatory decline, and correlations between available biomarkers (e.g., neurofilament light chain, cytokines) and disease trajectory. No new interventions or patient contact will occur.
- Conditions
- Amyotrophic Lateral Sclerosis (ALS), Amyotrophic Lateral Sclerosis &Amp; Other Neuromuscular Disorders
- Being tested
- Imaging and Clinical Reports
- Keywords
- Amyotrophic Lateral Sclerosis, MSC, biomedicine
- 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.
Imaging and Clinical ReportsBiological
Inclusion of existing imaging data (MRI, EMG reports) and standard clinical documentation, where available.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of decline in ALS Functional Rating Scale-Revised (ALSFRS-R) scores
Unit: points per month
Measured: 2 yearss after the first administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start13 May 2021
- Primary completion13 Aug 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocells Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143656
- Sponsor's protocol ID
- Bio120003
- Status last verified
- Aug 2025
- First submitted
- 20 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History and Biomarker Correlation Study in Amyotrophic Lateral Sclerosis: A Multicenter Retrospective Observational Registry
- ClinicalTrials.gov ID
- NCT07143656
- Acronym / sponsor ID
- Bio120003
- Conditions
- Amyotrophic Lateral Sclerosis (ALS), Amyotrophic Lateral Sclerosis &Amp; Other Neuromuscular Disorders
- Keywords
- Amyotrophic Lateral Sclerosis, MSC, biomedicine
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Biocells MedicalIndustry (pharma, biotech, devices)
- Study start
- 13 May 2021 (actual)
- Primary completion
- 13 Aug 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 27 Aug 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 retrospective observational study will analyze de-identified clinical data from patients with amyotrophic lateral sclerosis (ALS) collected at multiple centers over 7 years. The primary objective is to describe disease progression using the ALS Functional Rating Scale-Revised (ALSFRS-R). Secondary objectives include evaluating survival, ventilatory decline, and correlations between available biomarkers (e.g., neurofilament light chain, cytokines) and disease trajectory. No new interventions or patient contact will occur.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People aged ≥18 with ALS
Key inclusion criteria (4 listed)
- Diagnosis of amyotrophic lateral sclerosis (ALS) or motor neuron disease confirmed.
- Age ≥18 years.
- Availability of at least one ALS Functional Rating Scale-Revised (ALSFRS-R) score.
- Availability of longitudinal follow-up data.
Key exclusion criteria (2 listed)
- Patients with alternative diagnoses that mimic ALS (e.g., multifocal motor neuropathy, cervical myelopathy, myasthenia gravis).
- Absence of medical records
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 |
|---|---|---|
| Imaging and Clinical ReportsInclusion of existing imaging data (MRI, EMG reports) and standard clinical documentation, where available. | Biological | – |
Primary outcome
Rate of decline in ALS Functional Rating Scale-Revised (ALSFRS-R) scores
Time frame: 2 yearss after the first administration
Unit: points per month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis (ALS) and Amyotrophic Lateral Sclerosis &Amp; Other Neuromuscular Disorders, run by Biocells Medical at 1 site in Poland.
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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 28 Aug 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 Poland. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Rate of decline in ALS Functional Rating Scale-Revised (ALSFRS-R) scores (time frame: 2 yearss after the first administration). 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 28 Aug 2025.