Health TrialsbyHealthPanel

Safety and Feasibility of Nasal Delivery of Human Dental Follicle Mesenchymal Stem Cell-Derived Exosomes for Negative Symptoms in Treatment-Resistant Schizophrenia: A Pilot Study

ConditionSchizophrenia Negative Type
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorZigong Mental Health Center

About this trial

The goal of this clinical trial is to determine the safety and feasibility of nasal delivery of human dental follicle mesenchymal stem cell-derived exosomes in the treatment of negative symptoms of treatment-resistant schizophrenia. It will also learn about the preliminary efficacy of the exosomes. The main questions it aims to answer are:

Is the safety of the exosomes enough for participants? Is the feasibility of nasal delivery of exosomes for participants? Do the exosomes exert any benefits on the negative symptoms of treatment-resistant schizophrenia?

Participants will:

Take a nasal spray of exosomes twice weekly for 2 months Take vital sign checks every day, regular visits for an interview, and lab examinations

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • hDFSCs-Exo

    Biological/Vaccine

    Nasal delivery of exosomes derived from human dental follicle mesenchymal stem cells (1×10\^9, 2×10\^9, 4×10\^9, 8×10\^9, 16×10\^9) twice weekly for eight weeks

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: hDFSCs-ExoExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The incidence and severity of adverse events (AE) and serious adverse events (SAE).

Time frame
week 0, 2, 4, 8, 12, 16, 20, and 24
2

Incidence of dose-limiting toxicity (DLT)

Specific toxic reactions related to the investigational drug that occur during the DLT observation period (within 28 days after a single administration)

Time frame
The observation period for DLT is within 28 days after a single administration
3

The incidence rate of abnormal laboratory tests

Blood routine, liver and kidney function (elevated ALT/AST, elevated creatinine, etc.), myocardial enzyme spectrum, inflammatory factors, allergic indicators (IgE)

Time frame
Week 0, 2, 4, 8, 12, 16, 20, and 24
4

The incidence of abnormal vital signs and electrocardiogram (ECG)

Time frame
Week 0, 2, 4, 8, 12, 16, 20, and 24

Secondary outcomes

1

Changes in the total score and negative symptom factor score of the PANSS scale

Time frame
week 0, 4, 8, 12, and 24
2

Changes in the total score and subscale scores of SANS (Negative Symptom Rating Scale)

Time frame
week 0, 4, 8, 12, and 24
3

Changes in the Clinical General Impression Scale - Severity (CGI-S) score

Time frame
Week 0, 4, 8, 12, 24
4

Changes in the Calgary Schizophrenia and Depression Scale (CDSS) score

Time frame
Week 0, 4, 8, 12, 24

Other outcomes

1

Changes in the functional connections of brain networks in MRI

Time frame
week 0, 8
2

The change in the concentration of oxygenated hemoglobin (Oxy-Hb) in fNIRS

Time frame
week 0, 8

Locations

This trial has no locations.

Sponsors and contacts

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

Zigong Mental Health Center

Lead sponsor

Chengdu Celincare Biotechnology Co., Ltd.

Collaborator

Source ClinicalTrials.gov

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