NCT05127369

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: CAR-T (Shanghai) Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

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

Interventions

Type	Name	Description
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	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

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-12-30
• Completion: 2024-06-30
• First posted: 2021-11-19
• Last updated: 2021-11-19