Monitoring of Outcomes of Cellular and Exosome-based Therapies in Autoinflammatory and Post-infectious Neuroinflammatory Syndromes

N/AActive Not RecruitingNCT07145502

Biocells Medical76 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Autoimmune Encephalitis Early-stage Panencephalitis Neuroinflammatory Demyelination

Interventions

Allogeneic MSC infusions (IV)BIOLOGICAL

Eligibility

Sex: ALLMin age: 6 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: from enrollment to the end of treatment at 8 weeks

Secondary Outcomes

Change in serum cytokine levels

IL-6, TNF-α, pg/mL

Time frame: 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)

Time frame: From the enrolment to the end of the treatment (8 weeks)