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

August 28, 2025 updated by: Biocells Medical
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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
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)
from enrollment to the end of treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum cytokine levels
Time Frame: From the enrolment till the end of the treatment (8 weeks)
IL-6, TNF-α, pg/mL
From the enrolment till the end of the treatment (8 weeks)
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)
From the enrolment to the end of the treatment (8 weeks)
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)
From the enrolment till the end of the treatment (8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biocells Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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