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

NCT ID: NCT07145502

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-19

Study Completion Date

2027-09-19

Brief Summary

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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.

Detailed Description

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Conditions

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Autoimmune Encephalitis Early-stage Panencephalitis Neuroinflammatory Demyelination

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Allogeneic MSC infusions (IV)

Intervention Type BIOLOGICAL

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

Interventions

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Allogeneic MSC infusions (IV)

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

Intervention Type BIOLOGICAL

Other Intervention Names

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MSC-derived exosomes (IV or intranasal) Supportive immunomodulatory agents

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biocells Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Biocells Medical

Warsaw, , Poland

Site Status

Countries

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Poland

Other Identifiers

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Bio120001

Identifier Type: -

Identifier Source: org_study_id

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