Not Yet RecruitingPhase 1/2

hUC-MSC-Exo Therapy for Autoimmune Encephalitis

38 participantsStarted 2025-11-01

Plain-language summary

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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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;
✓. Subjects of childbearing potential must agree to practice strict contraception during the study period.

Exclusion criteria

✕. 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;
✕. Current or history of any clinically significant systemic diseases judged by the investigator as unsuitable for inclusion, including but not limited to:
✕. Anatomical nasal abnormalities, nasal mucosal damage, severe rhinitis, or other nasal conditions affecting drug administration;
✕. Requiring nasogastric tube placement;
✕. Organ function meeting any of the following criteria:
✕. Absolute neutrophil count (ANC) \<1.5×10⁹/L, platelets (PLT) \<100×10⁹/L, hemoglobin (Hb) \<90 g/L

What they're measuring

DLT events

Timeframe: Within 24 weeks after drug administration

mRS

Timeframe: 24 weeks ±10 days

Trial details

NCT IDNCT07131683

SponsorXuanwu Hospital, Beijing

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-30

View on ClinicalTrials.gov More Autoimmune Encephalitis trials