hUC-MSC-Exo Therapy for Autoimmune Encephalitis
ConditionAutoimmune Encephalitis
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorXuanwu Hospital, Beijing
About this trial
This is a phase I/IIa study to investigate the safety and preliminary efficacy of intranasal admnistration of human umbilical mesenchymal stem cell-derived exosome (hUC-MSC-Exo) for patients with autoimmune encephalitis.
Eligibility criteria
Qualifiers
Aged 18-65 years, both male and female are eligible;
Diagnosis of autoimmune encephalitis within 3 months of onset (meeting the 2016 Graus and Dalmau diagnostic criteria), with positive serum/cerebrospinal fluid anti-NMDAR antibodies or anti-LGI1 antibodies;
Modified Rankin Scale (mRS) score ≥ 2 at enrollment;
The subject or legally authorized representative is able to sign the informed consent form;
Disqualifiers
Pre-morbid modified Rankin Scale (mRS) score ≥ 2;
Known allergy to any component of the investigational product or history of severe allergic reactions;
Presence of neurological or psychiatric disorders (e.g., cerebrovascular disease, Parkinson's disease, severe depression) deemed by the investigator to potentially impair trial participation or study assessments;
Severe cardiovascular diseases (e.g., congestive heart failure, severe arrhythmia, myocardial infarction)
Trial design
Treatments tested in this trial
- Human umbilical cord mesenchymal stem cell derived exosomes
- Placebo Control
Treatment groups
38 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Xuanwu Hospital, Beijing
Lead sponsor
ECHO Biotech
Collaborator
Source ClinicalTrials.gov