Treating Depression with Dental Pulp Stem Cells (DPSCs)

ABSTRACT

Clinical Study on the Safety and Efficacy of Dental Pulp Mesenchymal Stem Cell Injection in the Treatment of Depression
ClinicalTrials.gov Identifier: NCT05127369

Study information
Sponsor: CAR-T (Shanghai) Biotechnology Co., Ltd.
Responsible Party: CAR-T (Shanghai) Biotechnology Co., Ltd.
Study Phase: Phase I/II
Study Type: Interventional Clinical Trial (Randomized, Blind, Positive Drug Parallel-Controlled) Study Population: Adults diagnosed with depression.

BACKGROUND:Depression is a common mental health disorder that affects mood, cognition, and overall quality of life. Although antidepressant medications can be effective, many patients experience incomplete symptom relief or delayed therapeutic responses. Dental pulp stem cells (DPSCs) possess anti-inflammatory, immunomodulatory, and neurotrophic properties that may help restore neural function and improve depressive symptoms by targeting underlying biological mechanisms rather than symptoms alone.

METHODS:This single-center, randomized, blinded, Phase I/II clinical trial evaluates the safety and effectiveness of dental pulp mesenchymal stem cell injections in patients with depression. Participants are randomly assigned in a 1:1 ratio to receive either DPSC injections with a placebo capsule or fluoxetine hydrochloride (40 mg/day) with a placebo DPSC injection vehicle. The study includes a screening period of up to four weeks, an eight-week treatment period, and a twelve-month follow-up to assess treatment safety and clinical outcomes.

RESULTS:Researchers designed the study to compare improvements in depressive symptoms, treatment safety, and long-term outcomes between DPSC therapy and conventional antidepressant treatment.

CONCLUSIONS:This Phase I/II clinical trial investigates whether dental pulp stem cells can provide a safe and effective regenerative treatment for depression. If successful, DPSC therapy could represent a novel approach that complements or improves upon conventional antidepressant medications by promoting neuroregeneration and modulating neuroinflammation.

ClinicalTrials.gov Identifier: NCT05127369
Sponsor: CAR-T (Shanghai) Biotechnology Co., Ltd. Responsible Party: CAR-T (Shanghai) Biotechnology Co., Ltd.