By InvitationEarly Phase 1

Handheld MPI Imaging to Track Stem Cells in Osteoarthritis

China10 participantsStarted 2025-12-16

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

MPI-Based Joint Cavity Retention Rate of SPIO-labeled hUC-MSCs

Timeframe: Baseline (pre-injection) to Day 7 post-injection

Trial details

NCT IDNCT07313020

SponsorSoochow University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-16

View on ClinicalTrials.gov More Knee Arthritis Osteoarthritis trials