Registered Clinical Research on Neuroinflammatory Syndromes (NCT07145502)
- Dr. Uladzislau Tsvirko
- Nov 21, 2025
- 3 min read
Neuroinflammatory conditions of autoimmune or post-infectious origin represent a complex and often debilitating group of disorders affecting the central nervous system. These syndromes—including autoimmune encephalitis, post-infectious encephalopathies, and neuroinflammatory demyelination—can lead to cognitive impairment, neurological deficits, fatigue, and reduced quality of life. In many patients, standard immunomodulatory therapies provide incomplete or temporary benefit, highlighting the need for deeper clinical understanding and alternative supportive approaches.
In this context, BioCells Medical is the sponsor and clinical site of an officially registered observational study on ClinicalTrials.gov under the identifier NCT07145502, aimed at systematically monitoring outcomes of advanced regenerative medicine interventions in patients with neuroinflammatory syndromes.
Study Purpose and Scientific Focus
The study titled “Monitoring of Outcomes of Cellular and Exosome-based Therapies in Autoinflammatory and Post-infectious Neuroinflammatory Syndromes” is designed as a prospective, non-randomized, observational registry.
Its primary scientific objective is to evaluate how patients with autoimmune or post-infectious neuroinflammatory conditions respond clinically to stem cell-derived biologics, including allogeneic mesenchymal stem cells (MSCs) and MSC-derived exosomes, administered within individualized regenerative medicine protocols at BioCells Medical.
Rather than testing a standardized experimental drug, the study focuses on real-world clinical outcomes, tracking neurological function, inflammatory activity, and patient-reported quality of life following personalized regenerative interventions.
Key Components of the Study
Population and Data Scope
Enrollment: 76 patients
Age range: 6 to 70 years (pediatric, adult, and older adult populations)
Eligible conditions include:
Autoimmune encephalitis
Early-stage panencephalitis
Neuroinflammatory demyelination
Post-infectious neuroinflammatory syndromes
Patients are included if they have a confirmed diagnosis by a neurologist or immunologist and demonstrate insufficient response or relapse following conventional therapies. Diagnostic evaluation may include MRI findings, cerebrospinal fluid analysis, neuropsychological testing, and immunological profiling.
Interventions Observed
As an observational registry, the study monitors outcomes in patients receiving individualized regenerative protocols, which may include:
Allogeneic MSC infusions (intravenous)
MSC-derived exosomes (administered intravenously or intranasally)
Optional T-regulatory cell therapy in selected cases (experimental or compassionate-use basis)
No healthy volunteers are included, and no randomization is applied.
Main Outcome Measure
The primary outcome focuses on changes in neurological symptom severity, assessed using the National Institutes of Health Stroke Scale (NIHSS). Neurological status is evaluated from baseline through the end of the treatment observation period (8 weeks).
Secondary Assessments
Secondary outcome measures include:
Inflammatory biomarkers, such as serum cytokine levels (IL-6, TNF-α)
Patient-reported quality of life, assessed using validated instruments:
EQ-5D
SF-36
These measures allow correlation between clinical neurological changes, inflammatory activity, and patient-perceived health status.
Why This Research Matters
Neuroinflammatory syndromes often follow unpredictable clinical trajectories and may persist or recur despite standard immunosuppressive treatments. Observational registry studies such as NCT07145502 play a critical role in:
documenting real-world outcomes of advanced regenerative approaches,
identifying patterns of neurological and immunological response,
informing future interventional trial design,
supporting evidence-based personalization of care.
By systematically capturing functional, biological, and quality-of-life data, this study contributes to a more nuanced understanding of how regenerative medicine strategies may support patients with complex neuroimmune conditions.
BioCells Medical’s Contribution to Neuroinflammatory Research
As both sponsor and clinical site, BioCells Medical demonstrates its commitment to scientific transparency and responsible clinical research. The study is conducted at the BioCells Medical facility in Warsaw, Poland, and is registered on ClinicalTrials.gov in accordance with international standards for clinical research reporting.
Through this registry, BioCells Medical integrates certified laboratory-based regenerative technologies with structured clinical monitoring, contributing valuable data to the global scientific discussion on neuroinflammation and regenerative medicine.
Conclusion
The observational study NCT07145502 represents a significant scientific effort to monitor outcomes of cellular and exosome-based therapies in patients with autoimmune and post-infectious neuroinflammatory syndromes. By focusing on neurological function, inflammatory biomarkers, and quality of life, the study provides clinically relevant insights that may guide future research and personalized care strategies.
