Handheld MPI Imaging to Track Stem Cells in Osteoarthritis

Trial details

Who runs it

Soochow University

Trial code

NCT07313020

Record updated

12 May 2026

Original description

This clinical trial aims to evaluate the use of a handheld Magnetic Particle Imaging (MPI) device for real-time, non-invasive monitoring of human umbilical cord-derived mesenchymal stromal cells (UC-MSCs) in patients with knee osteoarthritis (OA). The primary objective is to visualize and quantify the distribution, retention, and survival of SPIO (superparamagnetic iron oxide)-labeled MSCs within the joint space following intra-articular injection. By correlating MPI signal dynamics with established clinical outcomes (e.g., WOMAC, VAS scores) and anatomical MRI assessments, the study seeks to predict treatment efficacy and optimize therapeutic strategies for OA.Read full original descriptionShow less

A Visualization Clinical Study Using a Handheld MPI Imaging Device for Monitoring Mesenchymal Stromal Cells in Osteoarthritis Treatment

This clinical trial aims to evaluate the use of a handheld Magnetic Particle Imaging (MPI) device for real-time, non-invasive monitoring of human umbilical cord-derived mesenchymal stromal cells (UC-MSCs) in patients with knee osteoarthritis (OA). The primary objective is to visualize and quantify the distribution, retention, and survival of SPIO (superparamagnetic iron oxide)-labeled MSCs within the joint space following intra-articular injection. By correlating MPI signal dynamics with established clinical outcomes (e.g., WOMAC, VAS scores) and anatomical MRI assessments, the study seeks to predict treatment efficacy and optimize therapeutic strategies for OA.

Current assessment of MSC therapy relies largely on MRI for structural evaluation, which has limited sensitivity for tracking early cell viability and migration. MPI offers high-contrast, radiation-free functional imaging capable of directly detecting SPIO-labeled cells. This study will enroll patients with mild-to-moderate OA (Kellgren-Lawrence grade II-III). Participants will receive a single injection of ferumoxytol-labeled UC-MSCs into the affected knee. MPI scans will be performed at multiple timepoints (day 1, 3, 7, and 30) to monitor cell homing, retention rate, and signal decay. MRI will be used in parallel to evaluate cartilage morphology and synovial changes.

The study expects to demonstrate that MPI can effectively track MSC behavior in vivo, providing a novel tool to understand cell therapy mechanisms, assess treatment response early, and potentially guide personalized OA management.

Inclusion: Diagnosis of knee osteoarthritis according to internationally accepted criteria (e.g., American College of Rheumatology criteria); Age between 18 and 75 years, inclusive; Radiographic Kellgren-Lawrence grade II or III in the target knee; Chronic knee pain of arthritic origin; Absence of local or systemic infection; No contraindications to joint cavity puncture as determined by hematological and biochemical tests; Willing and able to understand the study, provide informed consent, and comply with all study procedures.

Exclusion: Intra-articular injection (e.g., corticosteroids, hyaluronic acid) in the target knee within the past 3 months; Concurrent participation in another interventional clinical trial; Known active infection with HIV, hepatitis B virus, hepatitis C virus, or syphilis (positive serology); History of or current active malignancy; Known immunodeficiency disorder; Any other condition that, in the opinion of the investigator, would make the participant unsuitable for the study (e.g., significant comorbid illness); Lack of legal capacity or impaired capacity to provide informed consent; Body mass index (BMI) > 30 kg/m²; Congenital or acquired deformity of the target knee; Pregnant or breastfeeding women.

ClinicalTrials.gov NCT07313020