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

Depression Clinical Trial

Official title: Safety and Efficacy of Dental Pulp Mesenchymal Cells in the Treatment of Depression:

Status Not yet recruiting

Clinical 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

• NCT number: NCT05127369
• Study type: Interventional
• Source: CAR-T (Shanghai) Biotechnology Co., Ltd.
• Contact: Yong You, Doctor
• Phone: 0898-66809233
• Email: 652797262@qq.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2022
• Completion date: June 30, 2024