NCT07313020

Handheld MPI Imaging to Track Stem Cells in Osteoarthritis

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

• Status: Enrolling By Invitation
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Soochow University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Knee Arthritis Osteoarthritis

Interventions

Type	Name	Description
BIOLOGICAL	Human Umbilical Cord-derived Mesenchymal Stromal Cells (hUC-MSCs)	This clinical trial evaluates an integrated cell therapy and imaging protocol for knee osteoarthritis. The core intervention is a single intra-articular injection of ferumoxytol (SPIO)-labeled human umbilical cord-derived mesenchymal stromal cells (MSCs), administered under real-time image guidance using a handheld Magnetic Particle Imaging (MPI) scanner. Its unique features are: 1) Real-time MPI-guided delivery for precise joint cavity targeting; 2) Subsequent use of the same MPI technology for serial quantitative monitoring of cell distribution, retention, and signal decay in vivo; 3) Use of the clinically approved agent ferumoxytol as an MPI tracer. This theragnostic approach combines therapeutic cells with a matched imaging modality for guided delivery and longitudinal tracking, distinguishing it from standard blind injections or studies using MRI only for anatomical assessment.
OTHER	Ferumoxytol (SPIO) Solution for Injection (Placebo)	Single intra-articular injection of ferumoxytol (superparamagnetic iron oxide, SPIO) solution, without mesenchymal stromal cells. This serves as the placebo control. The injection is performed under real-time image guidance using the same handheld Magnetic Particle Imaging (MPI) scanner as the experimental group, and participants undergo identical MPI and MRI scanning schedules.

Timeline

• Start date: 2025-12-16
• Primary completion: 2026-02-16
• Completion: 2026-12-16
• First posted: 2025-12-31
• Last updated: 2025-12-31

Locations

1 site across 1 country: China