Schizophrenia Negative TypeEarly Phase 1NCT07485751
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
A Early Phase 1 study testing hDFSCs-Exo in people with Schizophrenia Negative Type, run by Zigong Mental Health Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia Negative Type
- What is being tested?
- hDFSCs-Exo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1) Conforms to the ICD-10 diagnosis of schizophrenia; 2) age between 18 and 60 years old; 3) course of more than 5 years of long-term inpatients; 4) the last 6 months without acute aggravating period, and no change in recent two months regimen; 5) to including clozapine, two different antipsychotics enough poor foot therapy treatment response; 6) positive and negative symptoms scale - negative symptom factor (PANSS - FSNS) 24 or more; 7) three core of PANSS negative symptoms (N1, N4 interchange and N6) at least 2 or 4; 6) clinical overall impression scale - illness severity (-s) CGI score of 4 or more points; 7) signed a written informed consent.
Who cannot join
- 1) Has a history of severe allergies; 2) there is a clear brain organic disease; 3) with serious body disease (such as the instability of coronary artery disease, malignant arrhythmia, liver and kidney function is not complete, bronchial asthma, COPD acute aggravating period, autoimmune diseases, etc.); 4) there is accord with the ICD - 10 patients with other psychiatric diagnosis standard sample obstacles (such as schizoaffective disorder, schizophrenia, bipolar I disorder, bipolar type Ⅱ dysfunction, broad developmental disabilities, mental retardation, delirium, dementia, forgotten obstacles or other cognitive impairment, etc.); 5) condition fluctuation, the need to adjust the drug solution; 6) don't cooperate with treatment, 7) with severe rhinitis, nasal allergies; 8) for nearly three months has a history of MECT therapy; 9) suicide risk; 10) during pregnancy or lactation women, female or male subjects and spouse has pregnancy at the time of test plan or over 3 months to test is not willing to use effective contraception (effective contraceptive measures such as birth control pills and condoms or intrauterine device, etc.); 11) other unfavorable into groups.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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?
Read more
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
- Conditions
- Schizophrenia Negative Type
- Being tested
- hDFSCs-Exo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hDFSCs-ExoBiological
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
| Study group | Role | What they receive |
|---|---|---|
| hDFSCs-Exo | Experimental | Not described Receives: Biological: hDFSCs-Exo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of adverse events (AE) and serious adverse events (SAE).
Measured: week 0, 2, 4, 8, 12, 16, 20, and 24
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)
Measured: The observation period for DLT is within 28 days after a single administration
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)
Measured: Week 0, 2, 4, 8, 12, 16, 20, and 24
The incidence of abnormal vital signs and electrocardiogram (ECG)
Measured: Week 0, 2, 4, 8, 12, 16, 20, and 24
Drug administration completion rate
Measured: week 8
Secondary outcomes (8)
Changes in the total score and negative symptom factor score of the PANSS scale
Measured: week 0, 4, 8, 12, and 24
Changes in the total score and subscale scores of SANS (Negative Symptom Rating Scale)
Measured: week 0, 4, 8, 12, and 24
Changes in the Clinical General Impression Scale - Severity (CGI-S) score
Measured: Week 0, 4, 8, 12, 24
Changes in the Calgary Schizophrenia and Depression Scale (CDSS) score
Measured: Week 0, 4, 8, 12, 24
Changes in the Montreal Cognitive Assessment Scale (MoCA) score
Measured: week 0, 4, 8, 12, 24
Changes in the completion time of connection test A/B (TMT-A/B)
Measured: week 0, 4, 8, 12, 24
Score changes of the Digit Span Test
Measured: week 0, 4, 8, 12, 24
Changes in Language Learning and Memory Test (VLMT) scores
Measured: week 0, 4, 8, 12, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia Negative TypeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zigong Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Chengdu Celincare Biotechnology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485751
- Sponsor's protocol ID
- 20260101
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07485751
- Acronym / sponsor ID
- 20260101
- Conditions
- Schizophrenia Negative Type
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Zigong Mental Health CenterUniversity, hospital or other
- Collaborators
- Chengdu Celincare Biotechnology Co., Ltd.
- Study start
- Mar 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hDFSCs-Exo | Experimental | Biological: hDFSCs-Exo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1) Conforms to the ICD-10 diagnosis of schizophrenia; 2) age between 18 and 60 years old; 3) course of more than 5 years of long-term inpatients; 4) the last 6 months without acute aggravating period, and no change in recent two months regimen; 5) to including clozapine, two different antipsychotics enough poor foot therapy treatment response; 6) positive and negative symptoms scale - negative symptom factor (PANSS - FSNS) 24 or more; 7) three core of PANSS negative symptoms (N1, N4 interchange and N6) at least 2 or 4; 6) clinical overall impression scale - illness severity (-s) CGI score of 4 or more points; 7) signed a written informed consent.
Key exclusion criteria (1 listed)
- 1) Has a history of severe allergies; 2) there is a clear brain organic disease; 3) with serious body disease (such as the instability of coronary artery disease, malignant arrhythmia, liver and kidney function is not complete, bronchial asthma, COPD acute aggravating period, autoimmune diseases, etc.); 4) there is accord with the ICD - 10 patients with other psychiatric diagnosis standard sample obstacles (such as schizoaffective disorder, schizophrenia, bipolar I disorder, bipolar type Ⅱ dysfunction, broad developmental disabilities, mental retardation, delirium, dementia, forgotten obstacles or other cognitive impairment, etc.); 5) condition fluctuation, the need to adjust the drug solution; 6) don't cooperate with treatment, 7) with severe rhinitis, nasal allergies; 8) for nearly three months has a history of MECT therapy; 9) suicide risk; 10) during pregnancy or lactation women, female or male subjects and spouse has pregnancy at the time of test plan or over 3 months to test is not willing to use effective contraception (effective contraceptive measures such as birth control pills and condoms or intrauterine device, etc.); 11) other unfavorable into groups.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hDFSCs-ExoNasal 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 | Biological | hDFSCs-Exo |
Primary outcome
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
Incidence of dose-limiting toxicity (DLT)
Time frame: The observation period for DLT is within 28 days after a single administration
Specific toxic reactions related to the investigational drug that occur during the DLT observation period (within 28 days after a single administration)
The incidence rate of abnormal laboratory tests
Time frame: Week 0, 2, 4, 8, 12, 16, 20, and 24
Blood routine, liver and kidney function (elevated ALT/AST, elevated creatinine, etc.), myocardial enzyme spectrum, inflammatory factors, allergic indicators (IgE)
The incidence of abnormal vital signs and electrocardiogram (ECG)
Time frame: Week 0, 2, 4, 8, 12, 16, 20, and 24
Drug administration completion rate
Time frame: week 8
8 secondary outcomes
Changes in the total score and negative symptom factor score of the PANSS scale
Time frame: week 0, 4, 8, 12, and 24
Changes in the total score and subscale scores of SANS (Negative Symptom Rating Scale)
Time frame: week 0, 4, 8, 12, and 24
Changes in the Clinical General Impression Scale - Severity (CGI-S) score
Time frame: Week 0, 4, 8, 12, 24
Changes in the Calgary Schizophrenia and Depression Scale (CDSS) score
Time frame: Week 0, 4, 8, 12, 24
Changes in the Montreal Cognitive Assessment Scale (MoCA) score
Time frame: week 0, 4, 8, 12, 24
Changes in the completion time of connection test A/B (TMT-A/B)
Time frame: week 0, 4, 8, 12, 24
Score changes of the Digit Span Test
Time frame: week 0, 4, 8, 12, 24
Changes in Language Learning and Memory Test (VLMT) scores
Time frame: week 0, 4, 8, 12, 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing hDFSCs-Exo in people with Schizophrenia Negative Type, run by Zigong Mental Health Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zigong Mental Health Center (+86 15881342476, liubo2511@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.