DepressionNCT05127369
Clinical Study on the Safety and Efficacy of Dental Pulp Mesenchymal Cells in the Treatment of Depression
A study testing Dental pulp mesenchymal cell injection and fluoxetine hydrochloride capsule in people with Depression, run by CAR-T (Shanghai) Biotechnology Co., Ltd..
Trial summary
This is a single center phase I / II clinical trial. Randomized, blind and positive drug parallel control were used to evaluate the safety and effectiveness of dental pulp mesenchymal cell injection in the treatment of depression 8 weeks after administration Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression
- What is being tested?
- Dental pulp mesenchymal cell injection and fluoxetine hydrochloride capsule
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- At the time of signing the informed consent form, the age of 18 ≤ 60, regardless of gender.
- 18.5kg/m2 ≤ body mass index (BMI) ≤ 35kg / m2, male weight ≥ 50kg, female weight ≥ 45kg.
- Women of childbearing age need to be able to ensure effective contraception (medically approved contraceptive measures, such as intrauterine device, contraceptive pill or condom) during the trial and within 3 months after the end of the trial.
- According to the diagnostic criteria of diagnostic and Statistical Manual of mental disorders (5th Edition) (dsm-5), it was diagnosed as severe depressive disorder, marked as moderate or severe, and without psychotic characteristics.
- The total score of Montgomery Asperger Depression Scale (MADRS) in screening period and baseline was ≥ 22, and the CGI-S score was ≥ 4.
- Compared with the screening period, the change in the total MADRS score at baseline did not exceed 25% of the screening period.
- The patients fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial and sign the written informed consent, and are willing to complete the whole trial process according to the trial requirements.
Who cannot join
- It meets dsm-5 diagnostic criteria for other mental disorders.
- A depressive episode secondary to physical or other mental illness.
- The researchers determined that there was a high risk of suicide: there were serious suicides and self injuries within 1 month before or during the screening; Or those who answered "yes" to item 5 of "suicidal ideation" in the screening Columbia suicide severity rating scale (c-ssrs).
- The depressive episode is ineffective after sufficient treatment with one or more antidepressants (at least 6 weeks according to the dosage in the manual).
- Those who had received electroconvulsive therapy (ECT) within 1 month before screening.
- Patients who have received other stem cell therapy.
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- Have a history of infection within 1 month before screening and need hospitalization and / or antibiotic treatment; Or currently using systemic sex hormones (glucocorticoids), immunosuppressants or cytotoxic therapy.
- Screening the patients who had been diagnosed with hyperthyroidism or hypothyroidism within the previous year and are still taking drugs; Or have a history of thyroid disease and thyroid stimulating hormone (TSH) is higher than 1.2 times the upper limit of normal value or lower than 0.8 times the lower limit of normal value;
- Patients with a history of epilepsy (excluding children's history of fever and convulsion).
- Persons with severe alcohol or drug dependence within 1 year before screening (excluding caffeine or nicotine); Or daily alcohol intake of or above 5 units (1 units =360mL wine or 45mL Baijiu or 120mL wine).
- Accompanied by severe or unstable cardiovascular, respiratory, liver, kidney, blood, endocrine and central nervous system diseases.
- Laboratory examination was abnormal, and the researcher determined that it was of important clinical significance, such as: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeded 2.5 times the upper limit of normal; Total bilirubin (TBIL) exceeds 1.5 times of the upper limit of normal value; Creatinine (CR) exceeded 1.2 times the upper limit of normal.
- QTc interval of ECG in screening stage > 450 ms (male) or 470 MS (female); Or have a family history of long QT interval syndrome, or have cardiac insufficiency, severe arrhythmia or ischemic heart disease and need drug treatment, have congenital heart disease, severe organic heart disease or have a history of this disease.
- HIV antibody, HBsAg, HCV antibody or syphilis serological test results are positive.
- Participated in clinical trials of other drugs within 30 days before screening.
- Pregnant or lactating women.
- Patients with contraindications or allergies treated in this study.
- The researcher considered that it was not suitable to participate in this experiment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Safety and Efficacy of Dental Pulp Mesenchymal Cells in the Treatment of Depression:
This is a single center phase I / II clinical trial. Randomized, blind and positive drug parallel control were used to evaluate the safety and effectiveness of dental pulp mesenchymal cell injection in the treatment of depression 8 weeks after administration
Read the detailed description
This is a single center phase I / II clinical trial. Randomized, blind and positive drug parallel control were used to evaluate the safety and effectiveness of dental pulp mesenchymal cell injection in the treatment of depression 8 weeks after administration. The positive control drug was fluoxetine hydrochloride capsule with a dose of 40mg / day.The study included screening period (no more than 4 weeks), treatment period (8 weeks), and follow-up period (12 months).Subjects who met the inclusion criteria and did not meet the exclusion criteria were randomly assigned to the experimental group and the control group in the ratio of 1:1.During 8 weeks of treatment, subjects in the experimental group were given dental pulp mesenchymal cell injection + fluoxetine hydrochloride capsule simulant; The subjects in the control group were given dental pulp mesenchymal cell injection vehicle + fluoxetine hydrochloride capsule. During the treatment period, dental pulp mesenchymal cell injection / vehicle was injected intravenously for 4 times at an interval of 2 weeks (once at 0, 2, 4 and 6 weeks respectively); At the same time, fluoxetine hydrochloride capsule / simulant was taken orally every day during the treatment period.The efficacy and safety were evaluated 2 weeks after intravenous administration (visit and evaluation at 2, 4, 6 and 8 weeks respectively). Safety telephone follow-up was conducted 4 weeks (10th week), 6 months and 12 months after the last intravenous administration.
- Conditions
- Depression
- Being tested
- Dental pulp mesenchymal cell injection, Dental pulp mesenchymal cell vehicle, fluoxetine hydrochloride capsule
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental pulp mesenchymal cell injectionDrug
Dental pulp mesenchymal cell injection was administered intravenously on D1, D15 (2 weeks), D29 (4 weeks) and d43 (6 weeks); Fluoxetine hydrochloride capsule / simulant was administered orally daily.
Dental pulp mesenchymal cell vehicleDrug
Dental pulp mesenchymal cell vehicle was administered intravenously on D1, D15 (2 weeks), D29 (4 weeks) and d43 (6 weeks); Fluoxetine hydrochloride capsule / simulant was administered orally daily.
fluoxetine hydrochloride capsuleDrug
fluoxetine hydrochloride capsule
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Dental pulp mesenchymal cell injection (dose: 0.1u/kg) + fluoxetine hydrochloride Receives: Drug: Dental pulp mesenchymal cell injection; Drug: fluoxetine hydrochloride capsule |
| control group | Active comparator | Dental pulp mesenchymal cell injection vehicle + fluoxetine hydrochloride capsule Receives: Drug: Dental pulp mesenchymal cell vehicle; Drug: fluoxetine hydrochloride capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total score of Montgomery Asperger Depression Scale (MADRS) decreased from baseline after 8 weeks of treatment
Measured: 8 weeks
Secondary outcomes (2)
Effective rate of treatment (effective: the total score of MADRS decreased by ≥ 50% compared with baseline)
Measured: 8 weeks
Remission rate of treatment (remission: MADRS total score ≤ 11 points)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start1 Jan 2022 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CAR-T (Shanghai) Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127369
- Sponsor's protocol ID
- KT013HAN001
- Status last verified
- Nov 2021
- First submitted
- 12 Nov 2021
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Dental Pulp Mesenchymal Cells in the Treatment of Depression:
- ClinicalTrials.gov ID
- NCT05127369
- Acronym / sponsor ID
- KT013HAN001
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- CAR-T (Shanghai) Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 19 Nov 2021 (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.
This is a single center phase I / II clinical trial. Randomized, blind and positive drug parallel control were used to evaluate the safety and effectiveness of dental pulp mesenchymal cell injection in the treatment of depression 8 weeks after administration
Detailed description
This is a single center phase I / II clinical trial. Randomized, blind and positive drug parallel control were used to evaluate the safety and effectiveness of dental pulp mesenchymal cell injection in the treatment of depression 8 weeks after administration. The positive control drug was fluoxetine hydrochloride capsule with a dose of 40mg / day.The study included screening period (no more than 4 weeks), treatment period (8 weeks), and follow-up period (12 months).Subjects who met the inclusion criteria and did not meet the exclusion criteria were randomly assigned to the experimental group and the control group in the ratio of 1:1.During 8 weeks of treatment, subjects in the experimental group were given dental pulp mesenchymal cell injection + fluoxetine hydrochloride capsule simulant; The subjects in the control group were given dental pulp mesenchymal cell injection vehicle + fluoxetine hydrochloride capsule. During the treatment period, dental pulp mesenchymal cell injection / vehicle was injected intravenously for 4 times at an interval of 2 weeks (once at 0, 2, 4 and 6 weeks respectively); At the same time, fluoxetine hydrochloride capsule / simulant was taken orally every day during the treatment period.The efficacy and safety were evaluated 2 weeks after intravenous administration (visit and evaluation at 2, 4, 6 and 8 weeks respectively). Safety telephone follow-up was conducted 4 weeks (10th week), 6 months and 12 months after the last intravenous administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Drug: Dental pulp mesenchymal cell injection, Drug: fluoxetine hydrochloride capsuleDental pulp mesenchymal cell injection (dose: 0.1u/kg) + fluoxetine hydrochloride |
| control group | Active comparator | Drug: Dental pulp mesenchymal cell vehicle, Drug: fluoxetine hydrochloride capsuleDental pulp mesenchymal cell injection vehicle + fluoxetine hydrochloride capsule |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- At the time of signing the informed consent form, the age of 18 ≤ 60, regardless of gender.
- 18.5kg/m2 ≤ body mass index (BMI) ≤ 35kg / m2, male weight ≥ 50kg, female weight ≥ 45kg.
- Women of childbearing age need to be able to ensure effective contraception (medically approved contraceptive measures, such as intrauterine device, contraceptive pill or condom) during the trial and within 3 months after the end of the trial.
- According to the diagnostic criteria of diagnostic and Statistical Manual of mental disorders (5th Edition) (dsm-5), it was diagnosed as severe depressive disorder, marked as moderate or severe, and without psychotic characteristics.
- The total score of Montgomery Asperger Depression Scale (MADRS) in screening period and baseline was ≥ 22, and the CGI-S score was ≥ 4.
Key exclusion criteria (18 listed)
- It meets dsm-5 diagnostic criteria for other mental disorders.
- A depressive episode secondary to physical or other mental illness.
- The researchers determined that there was a high risk of suicide: there were serious suicides and self injuries within 1 month before or during the screening; Or those who answered "yes" to item 5 of "suicidal ideation" in the screening Columbia suicide severity rating scale (c-ssrs).
- The depressive episode is ineffective after sufficient treatment with one or more antidepressants (at least 6 weeks according to the dosage in the manual).
- Those who had received electroconvulsive therapy (ECT) within 1 month before screening.
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 |
|---|---|---|
| Dental pulp mesenchymal cell injectionDental pulp mesenchymal cell injection was administered intravenously on D1, D15 (2 weeks), D29 (4 weeks) and d43 (6 weeks); Fluoxetine hydrochloride capsule / simulant was administered orally daily. | Drug | Test group |
| Dental pulp mesenchymal cell vehicleDental pulp mesenchymal cell vehicle was administered intravenously on D1, D15 (2 weeks), D29 (4 weeks) and d43 (6 weeks); Fluoxetine hydrochloride capsule / simulant was administered orally daily. | Drug | control group |
| fluoxetine hydrochloride capsulefluoxetine hydrochloride capsule | Drug | Test group, control group |
Primary outcome
The total score of Montgomery Asperger Depression Scale (MADRS) decreased from baseline after 8 weeks of treatment
Time frame: 8 weeks
2 secondary outcomes
Effective rate of treatment (effective: the total score of MADRS decreased by ≥ 50% compared with baseline)
Time frame: 8 weeks
Remission rate of treatment (remission: MADRS total score ≤ 11 points)
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Dental pulp mesenchymal cell injection and fluoxetine hydrochloride capsule in people with Depression, run by CAR-T (Shanghai) Biotechnology Co., Ltd..
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 7 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 19 Nov 2021. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong You, Doctor (0898-66809233, 652797262@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total score of Montgomery Asperger Depression Scale (MADRS) decreased from baseline after 8 weeks of treatment (time frame: 8 weeks). 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 19 Nov 2021.