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

NCT07145502 | Active Not Recruiting FDA Drug

• 1 other identifier: Bio120001
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Encephalitis; Early-stage Panencephalitis; Neuroinflammatory Demyelination

Keywords

Autoimmune encephalitis; Early-stage panencephalitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in serum cytokine levels

  From the enrolment till the end of the treatment (8 weeks)

• Change in patient-reported quality of life

  From the enrolment to the end of the treatment (8 weeks)

• Change in patient-reported quality of life

  From the enrolment till the end of the treatment (8 weeks)

Study Arms (1)

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)

Interventions

Allogeneic MSC infusions (IV) BIOLOGICAL

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

Also known as: MSC-derived exosomes (IV or intranasal), Supportive immunomodulatory agents

B1

Eligibility Criteria

• Age: 6 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Age 6-70
• Diagnosis of one of the eligible syndromes by neurologist or immunologist
• Unresponsive or partially responsive to conventional therapy
• Informed consent provided

You may not qualify if:

• Active malignancy
• Severe systemic infection
• Contraindications to IV biologics

Sponsors & Collaborators

• Biocells Medical: lead

Study Sites (1)

Biocells Medical

Warsaw, 01-234, Poland

Location

MeSH Terms

Conditions

Autoimmune Diseases of the Nervous System

Condition Hierarchy (Ancestors)

Nervous System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2025
• First Posted: August 28, 2025
• Study Start: September 19, 2022
• Primary Completion: July 15, 2024
• Study Completion (Estimated): September 19, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-08

Locations

PL (1)