Registered Clinical Research on Progressive Multiple Sclerosis (NCT07146087)
- Dr. Uladzislau Tsvirko
- Nov 4, 2025
- 3 min read
Multiple sclerosis (MS) is a chronic, immune-mediated neurological disorder characterized by inflammation, demyelination, and neurodegeneration within the central nervous system. In its progressive forms — particularly secondary progressive MS (SPMS) and primary progressive MS (PPMS) — the disease leads to accumulating disability, impaired mobility, cognitive decline, fatigue, and decreased quality of life for patients. Despite advances in immunomodulatory treatments, effective interventions to slow or alter progressive disability remain a significant unmet medical need.
In this scientific context, BioCells Medical is proud to be listed as a sponsor and clinical site for an officially registered clinical study on ClinicalTrials.gov under the identifier NCT07146087. This study focuses on investigating the potential role of allogeneic mesenchymal stem cell-derived exosomes as an innovative biological approach for progressive multiple sclerosis.
Study Purpose and Scientific Focus
The registered study, titled “Allogeneic Mesenchymal Stem Cell-Derived Exosome Therapy for Progressive Multiple Sclerosis,” is designed to explore whether intravenous infusions of allogeneic mesenchymal stem cell (MSC)-derived exosomes can influence the clinical course of progressive MS. Unlike traditional cell therapies, exosomes are nanoscale extracellular vesicles released by MSCs that carry proteins, lipids, microRNAs, and other signalling molecules involved in intercellular communication and may modulate immune and neuroprotective pathways.
This investigation aims to deepen scientific understanding of how MSC-derived exosomes may affect disease progression and disability measures in people with progressive MS. Rather than being a basic observational registry, this study represents an interventional clinical protocol evaluating a cell-derived biological product within a structured clinical framework.
Key Components of the Study
Population and Data Scope
The study enrolls adult participants (aged 18 and older) clinically diagnosed with progressive multiple sclerosis.
Participants undergo intravenous infusion of allogeneic MSC-derived exosomes as part of the investigational protocol.
The design emphasises real-world clinical relevance while aligning with safety and translational research principles inherent to advanced regenerative medicine.
Main Outcome Measure
The primary outcome focuses on changes in clinical disability and progression markers following exosome therapy. This typically includes serial assessments using validated neurological scoring systems, functional measures, and clinical disability scales relevant to MS progression.
Secondary Assessments
Secondary endpoints include:
monitoring adverse events and safety profiles post-infusion,
evaluation of immune and inflammatory biomarkers,
exploratory analysis of functional improvements in mobility, cognition, and daily activities.
These assessments aim to contextualise the biological and clinical impact of exosome administration in progressive MS.
Why This Research Matters
Progressive multiple sclerosis remains one of the most challenging phenotypes of MS to treat, with few therapies demonstrating meaningful impact on slowing accumulating disability. This study is significant because it investigates an innovative, cell-derived biological product — MSC-derived exosomes — which may offer paracrine and immunomodulatory activities without the complexities of whole-cell therapies.
Specifically, research on exosomes suggests they may:
deliver regulatory microRNAs and proteins that influence neuroinflammation,
support neural tissue homeostasis,
modulate aberrant immune responses contributing to progressive neurodegeneration.
Such mechanistic insights, when aligned with clinical outcomes, may help identify novel therapeutic pathways and inform future development of regenerative and biological treatment strategies for progressive MS.
BioCells Medical’s Contribution to MS Research
Serving as both sponsor and clinical site, BioCells Medical underscores its role in advancing regenerative and translational research beyond routine clinical care. Participation in registries and intervention studies such as NCT07146087 reflects the institution’s commitment to:
scientific rigour and longitudinal data collection,
ethically grounded clinical investigation,
contribution to global clinical knowledge in severe neurological conditions.
By integrating a certified in-house medical laboratory with patient-centred clinical protocols, BioCells Medical supports responsible exploration of MSC-derived exosome therapy as part of the broader scientific pursuit to address progressive MS.
Conclusion
The clinical investigation NCT07146087 represents a meaningful step in evaluating advanced regenerative approaches for progressive multiple sclerosis. By focusing on allogeneic MSC-derived exosome therapy and its potential influence on disease progression and functional outcomes, this study contributes valuable biological and clinical insights that may ultimately guide future therapeutic innovations.
