Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Human umbilical cord mesenchymal stem cell derived exosomes

    Biological/Vaccine

    Nasal spray of hUC-MSC-Exo (low dose: 2.5×10\^10 particles, mid-dose: 5.0×10\^10 particles, high-dose: 1.0×10\^11 particles), once per day for 7 days, then once per week for 3 weeks

  • Placebo Control

    Other intervention

    Nasal spray of placebo control, once per day for 7 days, then once per week for 3 weeks

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: Exosome groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

DLT events

Drug-related dose limiting toxicity (DLT)

Time frame
Within 24 weeks after drug administration
2

mRS

modified Ranking Scale (mRS), which ranges from 0 to 6, with higher scores indicating worse outcome, and a score of 6 representing death.

Time frame
24 weeks ±10 days

Secondary outcomes

1

AE and SAE

Adverse events and severe adverse events

Time frame
Within 24 weeks after drug administration
2

mRS

modified Ranking Scale (mRS), which ranges from 0 to 6, with higher scores indicating worse outcome, and a score of 6 representing death.

Time frame
5 weeks (±3 days), 12 weeks (±5 days)
3

Percentage of mRS 0-2

Percentage of mRS 0-2. modified Ranking Scale (mRS), which ranges from 0 to 6, with higher scores indicating worse outcome, and a score of 6 representing death.

Time frame
5 weeks (±3 days), 12 weeks (±5 days), 24 weeks (±10 days)
4

Percentage of mRS improvement ≧ 1

Percentage of mRS improvement ≧ 1. modified Ranking Scale (mRS), which ranges from 0 to 6, with higher scores indicating worse outcome, and a score of 6 representing death.

Time frame
5 weeks (±3 days), 12 weeks (±5 days), 24 weeks (±10 days)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xuanwu Hospital, Beijing

Lead sponsor

ECHO Biotech

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: