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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis &Amp; Other Neuromuscular Disorders Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Biocells Medical

Warsaw, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

Imaging and Clinical Reports

Biological

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

Primary outcomes

Rate of decline in ALS Functional Rating Scale-Revised (ALSFRS-R) scores

Time frame: 2 yearss after the first administration

Unit: points per month

Sponsors and collaborators

Lead sponsor

Biocells Medical

Industry

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2028
Study completion: 2028
First posted: Aug 27, 2025
Registry last updated: Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Active, not recruiting