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.

Study Overview

• Status: Active, not recruiting
• Conditions: Autoimmune Encephalitis; Early-stage Panencephalitis; Neuroinflammatory Demyelination
• Intervention / Treatment: Biological: Allogeneic MSC infusions (IV)

• Study Type: Observational
• Enrollment (Actual): 76

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 01-234
    • BioCells Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
B1; Age 6-70; Diagnosis of one of the eligible syndromes by neurologist or immunologist; Unresponsive or partially responsive to conventional therapy; Informed consent provided	Biological: Allogeneic MSC infusions (IV); Optional T-reg therapy (experimental/compassionate-use basis); Other Names: MSC-derived exosomes (IV or intranasal); Supportive immunomodulatory agents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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)

Collaborators and Investigators

• Sponsor: Biocells Medical

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2022
• Primary Completion (Actual): July 15, 2024
• Study Completion (Estimated): September 19, 2027

Study Registration Dates

• First Submitted: June 8, 2025
• First Submitted That Met QC Criteria: August 20, 2025
• First Posted (Estimated): August 28, 2025

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 28, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Autoimmune encephalitis; Early-stage panencephalitis
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System
• Other Study ID Numbers: Bio120001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No