Handheld MPI Imaging to Track Stem Cells in Osteoarthritis

Official title

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

Overview

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.

Interventions

• 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
• 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.

Primary outcome measures

• MPI-Based Joint Cavity Retention Rate of SPIO-labeled hUC-MSCs [Time frame: Baseline (pre-injection) to Day 7 post-injection]

Secondary outcome measures (1)

• Change in WOMAC Total Score [Time frame: Baseline to Week 6 post-injection]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Hainan General Hospital — Haikou

Publications

• Feng X, Gao P, Li Y, Hui H, Jiang J, Xie F, Tian J. First magnetic particle imaging to assess pulmonary vascular leakage in vivo in the acutely injured and fibrotic lung. Bioeng Transl Med. 2023 Nov 29;9(2):e10626. doi: 10.1002/btm2.10626. eCollection 2024 Mar. PMID 38435827
• Ferreira-Filho VC, Morais B, Vieira BJC, Waerenborgh JC, Carmezim MJ, Toth CN, Meme S, Lacerda S, Jaque D, Sousa CT, Campello MPC, Pereira LCJ. Influence of SPION Surface Coating on Magnetic Properties and Theranostic Profile. Molecules. 2024 Apr 17;29(8):1824. doi: 10.3390/molecules29081824. PMID 38675647
• Nejadnik H, Tseng J, Daldrup-Link H. Magnetic resonance imaging of stem cell-macrophage interactions with ferumoxytol and ferumoxytol-derived nanoparticles. Wiley Interdiscip Rev Nanomed Nanobiotechnol. 2019 Jul;11(4):e1552. doi: 10.1002/wnan.1552. Epub 2019 Feb 7. PMID 30734542
• Matas J, Garcia C, Poblete D, Vernal R, Ortloff A, Luque-Campos N, Hidalgo Y, Cuenca J, Infante C, Cadiz MI, Khoury M, Luz-Crawford P, Espinoza F. A Phase I Dose-Escalation Clinical Trial to Assess the Safety and Efficacy of Umbilical Cord-Derived Mesenchymal Stromal Cells in Knee Osteoarthritis. Stem Cells Transl Med. 2024 Mar 15;13(3):193-203. doi: 10.1093/stcltm/szad088. PMID 38366909
• Pico OA, Espinoza F, Cadiz MI, Sossa CL, Becerra-Bayona SM, Salgado MCC, Rodriguez JER, Cardenas OFV, Cure JMQ, Khoury M, Arango-Rodriguez ML. Efficacy of a single dose of cryopreserved human umbilical cord mesenchymal stromal cells for the treatment of knee osteoarthritis:a randomized, controlled, double-blind pilot study. Cytotherapy. 2025 Feb;27(2):188-200. doi: 10.1016/j.jcyt.2024.09.005. Epub PMID 39503681
• Negoro T, Takagaki Y, Okura H, Matsuyama A. Trends in clinical trials for articular cartilage repair by cell therapy. NPJ Regen Med. 2018 Oct 11;3:17. doi: 10.1038/s41536-018-0055-2. eCollection 2018. PMID 30345076
• Xiang XN, Zhu SY, He HC, Yu X, Xu Y, He CQ. Mesenchymal stromal cell-based therapy for cartilage regeneration in knee osteoarthritis. Stem Cell Res Ther. 2022 Jan 10;13(1):14. doi: 10.1186/s13287-021-02689-9. PMID 35012666
• Vina ER, Kwoh CK. Epidemiology of osteoarthritis: literature update. Curr Opin Rheumatol. 2018 Mar;30(2):160-167. doi: 10.1097/BOR.0000000000000479. PMID 29227353

Identifiers

NCT: NCT07313020 · KXXSC2025-IIT-23

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗