Handheld MPI Imaging to Track Stem Cells in Osteoarthritis

Soochow University

Status and phase: Invitation-only; Early Phase 1

Conditions: Knee Arthritis Osteoarthritis

Treatments: Biological: Human Umbilical Cord-derived Mesenchymal Stromal Cells (hUC-MSCs); Other: Ferumoxytol (SPIO) Solution for Injection (Placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT07313020

KXXSC2025-IIT-23

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups, including a placebo group

UC-MSCs + SPIO + MPI Monitoring Group

Experimental group

Description:

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.

Treatment:

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

Placebo (SPIO Solution) Control Group

Placebo Comparator group

Description:

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.

Treatment:

Other: Ferumoxytol (SPIO) Solution for Injection (Placebo)