RecruitingNot ApplicableNCT06947746

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


Sponsor

Shanghai Changzheng Hospital

Enrollment

15 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cell therapy called HiSCs (a type of stem cell treatment) for people with rheumatoid arthritis (RA) whose knee joint symptoms have not improved enough with standard treatments. **You may be eligible if...** - You are between 18 and 65 years old - You have had a confirmed diagnosis of rheumatoid arthritis for at least 3 months - At the time of screening, you have at least one swollen and painful knee with inflammation confirmed by joint ultrasound - Your knee pain scores significantly on a standard pain scale (WOMAC score of 4 or higher) - Your symptoms have not improved adequately after 3 months of standard RA treatment **You may NOT be eligible if...** - Your RA is controlled by current treatment - You have other types of arthritis or joint conditions that could confuse the results - You have severe organ problems, active infections, or cancer - You are pregnant or breastfeeding - You have received certain prior treatments that could interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALhiSCs

hiSCs are derived from human induced pluripotent stem cells and exhibit immunomodulatory properties.


Locations(1)

Shanghai ChangZheng hospital

Shanghai, China

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NCT06947746


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