| Eligibility |
Inclusion Criteria:
1. At the time of signing the informed consent form, the age of 18 = 60, regardless of
gender.
2. 18.5kg/m2 = body mass index (BMI) = 35kg / m2, male weight = 50kg, female weight =
45kg.
3. 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.
4. 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.
5. The total score of Montgomery Asperger Depression Scale (MADRS) in screening period
and baseline was = 22, and the CGI-S score was = 4.
6. Compared with the screening period, the change in the total MADRS score at baseline
did not exceed 25% of the screening period.
7. 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.
Exclusion Criteria:
1. It meets dsm-5 diagnostic criteria for other mental disorders.
2. A depressive episode secondary to physical or other mental illness.
3. 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).
4. The depressive episode is ineffective after sufficient treatment with one or more
antidepressants (at least 6 weeks according to the dosage in the manual).
5. Those who had received electroconvulsive therapy (ECT) within 1 month before
screening.
6. Patients who have received other stem cell therapy.
7. 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.
8. 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;
9. Patients with a history of epilepsy (excluding children's history of fever and
convulsion).
10. 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).
11. Accompanied by severe or unstable cardiovascular, respiratory, liver, kidney, blood,
endocrine and central nervous system diseases.
12. 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.
13. 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.
14. HIV antibody, HBsAg, HCV antibody or syphilis serological test results are positive.
15. Participated in clinical trials of other drugs within 30 days before screening.
16. Pregnant or lactating women.
17. Patients with contraindications or allergies treated in this study.
18. The researcher considered that it was not suitable to participate in this experiment.
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