Registered Clinical Research on Amyotrophic Lateral Sclerosis (ALS) (NCT07143656)

BioCells Medical | ClinicalTrials.gov

Identifier: NCT07143656

Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative condition that affects motor neurons — the nerve cells responsible for controlling voluntary muscle movement. Over time, ALS leads to muscle weakness, difficulties with speech and swallowing, respiratory decline, and significant impairment in daily functioning. Despite extensive research, there remains an urgent need to better understand how this disease progresses and how it can be more effectively managed.

In this context, BioCells Medical is proud to be the sponsor and clinical site of an officially registered observational study on ClinicalTrials.gov under the identifier NCT07143656, focused on capturing real-world clinical data from patients living with ALS.

Study Purpose and Scientific Focus

The study titled “Amyotrophic Lateral Sclerosis: A Multicenter Retrospective Observational Registry” is designed as a retrospective observational registry, which means it compiles and analyzes existing clinical data from patients with ALS to better describe the natural history of the disease. This type of study does not involve new treatment interventions, but instead uses previously collected medical information to deepen scientific understanding of how ALS progresses over time.

Rather than testing a specific therapy, the research examines patients’ clinical outcomes and functional changes over years of follow-up. The overarching goal is to document patterns of disease progression that may inform future therapeutic strategies, clinical assessments, and research designs.

Key Components of the Study

Population and Data Scope

• Adults aged 18 years and older with a confirmed clinical diagnosis of ALS or related motor neuron disease are included.

• The registry compiles longitudinal, real-world clinical information, including functional assessments and clinical outcomes over time.

Main Outcome Measure

The primary focus is on describing disease progression using established clinical scales such as the ALS Functional Rating Scale–Revised (ALSFRS-R) — a validated tool that tracks changes in key daily functions (e.g., mobility, speech, swallowing).

Secondary Assessments

Secondary components of the research include survival data, ventilatory decline, and possible associations between functional progression and biological markers such as neurofilament light chain levels and cytokines. These measures can provide additional insight into the biological and clinical dynamics of ALS.

Why This Research Matters

Observational registries like NCT07143656 play an essential role in understanding the real-world experience of patients with ALS. By systematically compiling and analyzing historical clinical data, this research approach helps clarify:

• how ALS symptoms and functional abilities change over time

• which clinical measures are most sensitive to progression

• patterns that could guide future clinical trials and therapeutic development

• correlations between clinical outcomes and biological markers

This rich retrospective dataset complements interventional trials and contributes to the global scientific effort to better characterize ALS and its progression.

BioCells Medical’s Contribution to ALS Research

Being listed as both sponsor and clinical site for this study underscores BioCells Medical’s commitment to advancing neurological research beyond direct treatment protocols. Participation in global registries such as ClinicalTrials.gov reflects our dedication to scientific transparency, collaboration with the international research community, and long-term improvement of care frameworks for patients with ALS and related disorders.

Conclusion

The clinical registry NCT07143656 represents a meaningful scientific contribution to the understanding of ALS. By gathering and analyzing long-term clinical data, it helps paint a clearer picture of disease progression and functional decline, which is critical for improving how clinicians and researchers approach this condition.