An Early Phase 1 interventional study of Human Umbilical Cord-derived Mesenchymal Stromal Cells (hUC-MSCs) and Ferumoxytol (SPIO) Solution for Injection (Placebo) in Knee Arthritis Osteoarthritis, sponsored by Soochow University. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by Soochow University · Early Phase 1, Interventional, and 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.
Soochow University is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Participants in this group will receive a single intra-articular injection of ferumoxytol (SPIO)-labeled human umbilical cord-derived mesenchymal stromal cells (UC-MSCs, "TriCellPr-AC07" injection, 5-6×10\^7 cells). The injection will be guided in real-time by a handheld Magnetic Particle Imaging (MPI) device to ensure accurate placement. Participants will undergo longitudinal MPI scans (at Day 1, 3, 7, and 30 post-injection) to quantitatively monitor the distribution, retention, and signal decay (as a surrogate for cell survival) of the labeled cells. Standard MRI will also be performed at baseline and follow-up to assess structural changes in cartilage and synovium. Clinical outcomes (WOMAC, VAS, SF-36) will be assessed by blinded evaluators.
Biological: Human Umbilical Cord-derived Mesenchymal Stromal Cells (hUC-MSCs)
Participants in this control group will receive a single intra-articular injection of an equivalent volume of ferumoxytol (SPIO) solution without mesenchymal stromal cells. The injection procedure, including the use of the handheld MPI device for real-time guidance, will be identical to the experimental group to maintain blinding. Participants will undergo the same schedule of MPI and MRI scans as the experimental group, as well as identical clinical assessments by blinded evaluators. This group serves to control for the potential effects of the injection procedure and the SPIO tracer itself.
Other: Ferumoxytol (SPIO) Solution for Injection (Placebo)
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.
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.
MPI-Based Joint Cavity Retention Rate of SPIO-labeled hUC-MSCs
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.
Time frame: Baseline (pre-injection) to Day 7 post-injection
Change in WOMAC Total Score
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.
Time frame: Baseline to Week 6 post-injection
Plan to share: Yes — De-identified individual participant data (IPD) that underlie the results reported in the primary publication of this study will be made available. This will include clinical outcomes (e.g., WOMAC, VAS scores), MRI assessment data, and quantitative MPI-derived metrics (e.g., signal retention rate, decay rate).
Supporting information: Study protocol, Sap, Csr, Analytic code
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