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Amyotrophic Lateral Sclerosis: A Multicenter Retrospective Observational Registry

Natural History and Biomarker Correlation Study in Amyotrophic Lateral Sclerosis: A Multicenter Retrospective Observational Registry

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07143656
Enrollment
36
Registered
2025-08-27
Start date
2021-05-13
Completion date
2028-09-01
Last updated
2025-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis (ALS), Amyotrophic Lateral Sclerosis &Amp; Other Neuromuscular Disorders

Keywords

Amyotrophic Lateral Sclerosis, MSC, biomedicine

Brief 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). 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.

Interventions

BIOLOGICALImaging and Clinical Reports

Inclusion of existing imaging data (MRI, EMG reports) and standard clinical documentation, where available.

Sponsors

Biocells Medical
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

1. Diagnosis of amyotrophic lateral sclerosis (ALS) or motor neuron disease confirmed. 2. Age ≥18 years. 3. Availability of at least one ALS Functional Rating Scale-Revised (ALSFRS-R) score. 4. Availability of longitudinal follow-up data.

Exclusion criteria

1. Patients with alternative diagnoses that mimic ALS (e.g., multifocal motor neuropathy, cervical myelopathy, myasthenia gravis). 2. Absence of medical records

Design outcomes

Primary

MeasureTime frameDescription
Rate of decline in ALS Functional Rating Scale-Revised (ALSFRS-R) scores2 yearss after the first administrationUnit: points per month

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026