Clinical Research Registry

Background

Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative condition that destroys motor neurons responsible for voluntary movement — leading to muscle weakness, loss of speech and swallowing, respiratory decline, and ultimately profound physical dependence. Despite decades of intensive research, there remains no curative treatment, and the mechanisms driving disease variability across patients are incompletely understood.

Study Purpose

This retrospective observational registry is designed to systematically compile and analyse existing clinical data from patients with ALS treated at BioCells Medical. Rather than testing a new intervention, the study examines how disease evolves over time, what functional trajectories are observed, and how different patient profiles correlate with clinical outcomes.

Scientific Significance

ALS observational registries provide the clinical community with critical epidemiological and longitudinal data that inform therapeutic trial design, patient stratification, and outcome benchmarking. NCT07143656 contributes to this global evidence base by documenting real-world clinical trajectories at a specialised European regenerative medicine centre, helping contextualise functional observations within the broader natural history of the disease.

Background

Neuroinflammatory conditions — encompassing autoimmune encephalitis, post-infectious encephalopathies, and neuroinflammatory demyelination — represent a complex group of central nervous system disorders that can cause profound cognitive impairment, neurological deficits, fatigue, and reduced quality of life. In many patients, standard immunomodulatory therapies provide incomplete or only transient relief, underscoring an urgent clinical need for deeper understanding of alternative supportive approaches.

Study Purpose

This prospective observational registry systematically monitors clinical outcomes in patients with autoimmune or post-infectious neuroinflammatory syndromes who receive individualised regenerative medicine protocols at BioCells Medical. The study captures neurological function, inflammatory biomarkers, and patient-reported quality of life over an 8-week observation window, generating structured real-world evidence for advanced cellular and exosome-based therapeutic approaches.

Interventions Observed

• •Allogeneic MSC infusions (intravenous)
• •MSC-derived exosomes (intravenous or intranasal)
• •Optional T-regulatory cell therapy (compassionate-use basis, selected cases)

Scientific Significance

Observational studies of this design play a critical role in generating hypothesis-forming evidence for emerging therapeutic modalities. NCT07145502 contributes structured prospective data on how cellular and exosome-based interventions perform in a heterogeneous neuroinflammatory population — data that is currently scarce in the global literature. The inclusion of paediatric, adult, and older adult participants (ages 6–70) adds important breadth to the evidence base.

Background

Multiple sclerosis, in its progressive forms — secondary progressive (SPMS) and primary progressive (PPMS) — represents one of the most therapeutically challenging phenotypes in neurology. Despite significant advances in immunomodulatory treatments for relapsing MS, effective interventions capable of meaningfully slowing the accumulation of disability in progressive disease remain a profound unmet medical need affecting millions of patients worldwide.

Study Purpose

This interventional study investigates whether intravenous infusions of allogeneic mesenchymal stem cell (MSC)-derived exosomes can influence the clinical course of progressive MS. Unlike whole-cell therapies, exosomes are nanoscale extracellular vesicles produced by MSCs that carry proteins, lipids, and microRNAs involved in immunomodulation, intercellular communication, and neuroprotection — offering potential therapeutic activity without the complexities associated with live cell administration.

Proposed Mechanisms of Action

• •Delivery of regulatory microRNAs influencing neuroinflammation
• •Paracrine immunomodulatory signals modulating aberrant immune responses
• •Support for neural tissue homeostasis via bioactive molecular cargo
• •Potential neuroprotective activity in regions of progressive neurodegeneration

Scientific Significance

MSC-derived exosome therapy represents one of the most scientifically promising frontiers in regenerative neurology. By delivering regulatory biological signals — including anti-inflammatory microRNAs and neuroprotective proteins — without the logistical and regulatory complexity of live-cell products, exosomes offer a potentially scalable and reproducible biological platform. NCT07146087 positions BioCells Medical at the forefront of translational research in this emerging field, contributing the first structured clinical data from a European setting on exosome therapy specifically in progressive MS.