Autoimmune Encephalitis, Early-stage Panencephalitis, Neuroinflammatory Demyelination
Conditions
Keywords
Autoimmune encephalitis, Early-stage panencephalitis
Brief summary
This is a prospective, non-randomized, observational registry study evaluating the clinical outcomes of patients with autoimmune or post-infectious neuroinflammatory syndromes receiving stem cell-derived biologics (including mesenchymal stem cells and exosomes) at Biocells Medical clinics. The study aims to track improvements in neurological function, inflammatory biomarkers, and patient-reported quality of life following individualized regenerative interventions.
Interventions
BIOLOGICALAllogeneic MSC infusions (IV)
Optional T-reg therapy (experimental/compassionate-use basis)
Sponsors
Biocells Medical
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* • Age 6-70 * Diagnosis of one of the eligible syndromes by neurologist or immunologist * Unresponsive or partially responsive to conventional therapy * Informed consent provided
Exclusion criteria
* • Active malignancy * Severe systemic infection * Contraindications to IV biologics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in neurological symptom severity | from enrollment to the end of treatment at 8 weeks | Change in neurological symptom severity as measured by the National Institutes of Health Stroke Scale (NIHSS; range 0-42, higher scores indicate greater severity) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum cytokine levels | From the enrolment till the end of the treatment (8 weeks) | IL-6, TNF-α, pg/mL |
| Change in patient-reported quality of life | From the enrolment to the end of the treatment (8 weeks) | EQ-5D (range: 5-25, lower scores indicate better health-related quality of life) |
Countries
Poland
Outcome results
None listed