NCT06947746

HiSCs in the Treatment of Rheumatoid Arthritis

A Single-arm Clinical Study Assessing the Safety, Tolerability, and Preliminary Efficacy of a Single Intra-Articular Injection of hiSCs for Rheumatoid Arthritis Treatment

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Shanghai Changzheng Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This trial is a single-center, single-arm exploratory clinical study aimed at assessing the safety, tolerability, and preliminary efficacy of a single intra-articular injection of hiSCs for the treatment of rheumatoid arthritis.

Detailed description

This trial is a single-center, single-arm exploratory clinical study aimed at assessing the safety, tolerability, and preliminary efficacy of a single intra-articular injection of hiSCs for the treatment of rheumatoid arthritis. In this trial, participants who have given informed consent will be screened to determine their eligibility according to the inclusion and exclusion criteria. The study intervention consists of a single injection of hiSCs, and the primary endpoint will be assessed during the 24-week follow-up visit after the cell injection.

Conditions

• Rheumatoid Arthritis (RA)

Interventions

Type	Name	Description
BIOLOGICAL	hiSCs	hiSCs are derived from human induced pluripotent stem cells and exhibit immunomodulatory properties.

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-06-01
• Completion: 2027-04-01
• First posted: 2025-04-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: China