Osteoarthritis Treatment Utilizing Dental Pulp Stem Cells (DPSCs)

ABSTRACT

Clinical Study of Pulp Mesenchymal Stem Cells in the Treatment of Primary Mild to Moderate Knee Osteoarthritis
ClinicalTrials.gov Identifier: NCT04130100

Study information
Sponsor: CAR-T (Shanghai) Biotechnology Co., Ltd.
Responsible Party: CAR-T (Shanghai) Biotechnology Co., Ltd.
Study Phase: Early Phase I
Study Type: Interventional Clinical Trial (Randomized, Parallel Assignment)
Estimated Enrollment: 60 participants
Study Population: Adults diagnosed with primary mild to moderate knee osteoarthritis.

BACKGROUND:Primary knee osteoarthritis is a degenerative joint disease characterized by progressive cartilage deterioration, chronic pain, stiffness, and reduced mobility. Current therapies primarily relieve symptoms but do not regenerate damaged cartilage. Dental pulp stem cells (DPSCs) possess anti-inflammatory, immunomodulatory, and regenerative properties that may help repair cartilage, reduce inflammation, and improve joint function.

METHODS:This randomized Early Phase I clinical trial compares allogeneic dental pulp mesenchymal stem cells with sodium hyaluronate, a commonly used treatment for knee osteoarthritis. Sixty participants are assigned to one of three treatment groups: a low-dose DPSC group, a high-dose DPSC group, or a sodium hyaluronate control group. Researchers will evaluate treatment safety along with improvements in pain, physical function, joint mobility, and overall clinical outcomes following administration.

RESULTS:The trial was designed to determine whether dental pulp stem cell therapy provides greater clinical benefit than sodium hyaluronate while maintaining an acceptable safety profile.

CONCLUSIONS:This Early Phase I clinical trial investigates whether dental pulp stem cells can provide a safe and effective regenerative treatment for primary mild to moderate knee osteoarthritis. If successful, this approach could offer a regenerative alternative to conventional therapies by targeting the underlying joint damage rather than simply relieving symptoms.

ClinicalTrials.gov Identifier: NCT04130100
Sponsor: CAR-T (Shanghai) Biotechnology Co., Ltd.