Amyotrophic Lateral Sclerosis: A Multicenter Retrospective Observational Registry

NCT07143656 | Active Not Recruiting FDA Drug

• 1 other identifier: Bio120003
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Amyotrophic Lateral Sclerosis; MSC; biomedicine

Outcome Measures

Primary Outcomes (1)

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

  Unit: points per month

  2 yearss after the first administration

Interventions

Imaging and Clinical Reports BIOLOGICAL

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

People aged ≥18 with ALS

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Biocells Medical: lead

Study Sites (1)

Biocells Medical

Warsaw, Poland

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 27, 2025
• Study Start: May 13, 2021
• Primary Completion (Estimated): August 13, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)