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NCT Number: NCT07145502

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Autoimmune Encephalitis Autoimmune Diseases Autoimmune Diseases of the Nervous System Early-stage Panencephalitis Immune System Diseases Nervous System Diseases Neuroinflammatory Demyelination

Age range

6 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Biocells Medical

Warsaw, 01-234, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Allogeneic MSC infusions (IV)

Biological

Optional T-reg therapy (experimental/compassionate-use basis)

Other names: MSC-derived exosomes (IV or intranasal), Supportive immunomodulatory agents

Primary outcomes

  1. Change in neurological symptom severity

    Time frame: 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 outcomes

  1. Change in serum cytokine levels

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

    IL-6, TNF-α, pg/mL

  2. Change in patient-reported quality of life

    Time frame: 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)

  3. Change in patient-reported quality of life

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

    SF-36 (range: 0-100, higher scores indicate better health-related quality of life)

Sponsors and collaborators

Lead sponsor

Biocells Medical

Industry

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2027
First posted
Aug 28, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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