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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B1 |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic MSC infusions (IV) | Biological | Optional T-reg therapy (experimental/compassionate-use basis) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in neurological symptom severity | Change in neurological symptom severity as measured by the National Institutes of Health Stroke Scale (NIHSS; range 0-42, higher scores indicate greater severity) | from enrollment to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum cytokine levels | IL-6, TNF-α, pg/mL | From the enrolment till the end of the treatment (8 weeks) |
| Change in patient-reported quality of life | EQ-5D (range: 5-25, lower scores indicate better health-related quality of life) |
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Inclusion Criteria:
• Age 6-70
Exclusion Criteria:
• Active malignancy
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The study will include pediatric, adult, and older adult patients aged 6 to 70 years who present with clinically confirmed or strongly suspected neuroinflammatory conditions of autoimmune or post-infectious origin. These include but are not limited to autoimmune encephalitis, post-viral encephalopathies (e.g., following measles, CMV, EBV, SARS-CoV-2), early-stage panencephalitis, and chronic neuroimmune syndromes such as ME/CFS and long COVID with CNS involvement.
Patients are eligible for inclusion if they have a persistent neuroinflammatory or neurocognitive condition that has not responded adequately to standard therapies or has relapsed. Diagnostic confirmation may include MRI findings, CSF analysis, neuropsychological testing, and immunological profiling (e.g., autoantibodies, cytokines).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biocells Medical | Warsaw | 01-234 | Poland |
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| From the enrolment to the end of the treatment (8 weeks) |
| Change in patient-reported quality of life | SF-36 (range: 0-100, higher scores indicate better health-related quality of life) | From the enrolment till the end of the treatment (8 weeks) |
| ID | Term |
|---|---|
| D020274 | Autoimmune Diseases of the Nervous System |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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