Clinical Study on the Safety and Efficacy of Dental Pulp Mesenchymal Cells in the Treatment of Depression

Sponsor
CAR-T (Shanghai) Biotechnology Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05127369
Collaborator
(none)
48
Enrollment
2
Arms
29.9
Anticipated Duration (Months)

Study Details

Study Description

Brief 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

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Dental pulp mesenchymal cell injection
  • Drug: Dental pulp mesenchymal cell vehicle
  • Drug: fluoxetine hydrochloride capsule
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Safety and Efficacy of Dental Pulp Mesenchymal Cells in the Treatment of Depression:
Anticipated Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

ArmIntervention/Treatment
Experimental: Test group

Dental pulp mesenchymal cell injection (dose: 0.1u/kg) + fluoxetine hydrochloride

Drug: Dental pulp mesenchymal cell injection
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.

Drug: fluoxetine hydrochloride capsule
fluoxetine hydrochloride capsule

Active Comparator: control group

Dental pulp mesenchymal cell injection vehicle + fluoxetine hydrochloride capsule

Drug: Dental pulp mesenchymal cell vehicle
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.

Drug: fluoxetine hydrochloride capsule
fluoxetine hydrochloride capsule

Outcome Measures

Primary Outcome Measures

  1. The total score of Montgomery Asperger Depression Scale (MADRS) decreased from baseline after 8 weeks of treatment [8 weeks]

Secondary Outcome Measures

  1. Effective rate of treatment (effective: the total score of MADRS decreased by ≥ 50% compared with baseline) [8 weeks]

  2. Remission rate of treatment (remission: MADRS total score ≤ 11 points) [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • CAR-T (Shanghai) Biotechnology Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CAR-T (Shanghai) Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05127369
Other Study ID Numbers:
  • KT013HAN001
First Posted:
Nov 19, 2021
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 19, 2021