Autoimmune EncephalitisNCT07145502
Monitoring of Outcomes of Cellular and Exosome-based Therapies in Autoinflammatory and Post-infectious Neuroinflammatory Syndromes
An observational study of Autoimmune Encephalitis and Early-stage Panencephalitis, run by Biocells Medical at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 70 years
- Conditions the study is for
- Autoimmune Encephalitis, Early-stage Panencephalitis, Neuroinflammatory Demyelination
- What is being tested?
- Allogeneic MSC infusions (IV)
- Type of treatment
- Injection or infusion
- How many people
- 76 participants
- Where
- 1 sitePoland
- Study dates
- 19 Sep 2022to 19 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- • Age 6-70
- Diagnosis of one of the eligible syndromes by neurologist or immunologist
- Unresponsive or partially responsive to conventional therapy
- Informed consent provided
Who cannot join
- • Active malignancy
- Severe systemic infection
- Contraindications to IV biologics
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Allogeneic MSC infusions (IV)
- Keywords
- Autoimmune encephalitis, Early-stage panencephalitis
- Medical subject headings
- Autoimmune Diseases of the Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic MSC infusions (IV)Biological
Also called MSC-derived exosomes (IV or intranasal), Supportive immunomodulatory agents
Optional T-reg therapy (experimental/compassionate-use basis)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Allogeneic MSC infusions (IV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: from enrollment to the end of treatment at 8 weeks
Secondary outcomes (3)
Change in serum cytokine levels
IL-6, TNF-α, pg/mL
Measured: 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)
Measured: 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)
Measured: From the enrolment till the end of the treatment (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start19 Sep 2022
- Primary completion15 Jul 2024
- Study completion19 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune EncephalitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocells Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145502
- Sponsor's protocol ID
- Bio120001
- Status last verified
- Aug 2025
- First submitted
- 8 Jun 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Outcomes of Cellular and Exosome-based Therapies in Autoinflammatory and Post-infectious Neuroinflammatory Syndromes
- ClinicalTrials.gov ID
- NCT07145502
- Acronym / sponsor ID
- Bio120001
- Keywords
- Autoimmune encephalitis, Early-stage panencephalitis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Biocells MedicalIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 19 Sep 2027 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| B1 | – | Biological: Allogeneic MSC infusions (IV)* Age 6-70 * Diagnosis of one of the eligible syndromes by neurologist or immunologist * Unresponsive or partially responsive to conventional therapy * Informed consent provided |
Who may qualify
- Ages
- 6 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- • Age 6-70
Key exclusion criteria (3 listed)
- • Active malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic MSC infusions (IV)Also: MSC-derived exosomes (IV or intranasal), Supportive immunomodulatory agentsOptional T-reg therapy (experimental/compassionate-use basis) | Biological | B1 |
Primary outcome
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)
3 secondary outcomes
Change in serum cytokine levels
Time frame: 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)
Change in patient-reported quality of life
Time frame: From the enrolment till the end of the treatment (8 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Encephalitis and Early-stage Panencephalitis, run by Biocells Medical at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in neurological symptom severity (time frame: from enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.