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Enrolling by Invitation

NCT Number: NCT07313020

Handheld MPI Imaging to Track Stem Cells in Osteoarthritis

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.

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Key information

Conditions

Knee Arthritis Osteoarthritis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Hainan General Hospital

Haikou, Hainan, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Human Umbilical Cord-derived Mesenchymal Stromal Cells (hUC-MSCs)

Biological

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.

Ferumoxytol (SPIO) Solution for Injection (Placebo)

Other

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.

Primary outcomes

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

    Time frame: Baseline (pre-injection) to Day 7 post-injection

    The percentage of the total injected Magnetic Particle Imaging (MPI) signal that remains within the target knee joint cavity at Day 7 post-injection. This quantitative measure, calculated using specialized MPI analysis software (e.g., Magnetic Particle Imaging Lab toolbox), serves as a primary indicator of successful cell homing and initial localization at the intended therapeutic site.

Secondary outcomes

  1. Change in WOMAC Total Score

    Time frame: Baseline to Week 6 post-injection

    Change from baseline in the total score of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC is a validated patient-reported outcome measure assessing pain (5 items), stiffness (2 items), and physical function (17 items) in knee osteoarthritis. Scores range from 0 (best) to 96 (worst). A negative change indicates improvement.

Sponsors and collaborators

Lead sponsor

Soochow University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 31, 2025
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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