A Visualization Clinical Study Using a Handheld MPI Imaging Device for Monitoring Mesenchymal Stromal Cells in Osteoarthritis Treatment
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- MPI-Based Joint Cavity Retention Rate of SPIO-labeled hUC-MSCs
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
UC-MSCs + SPIO + MPI Monitoring Group
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.
干预措施: Human Umbilical Cord-derived Mesenchymal Stromal Cells (hUC-MSCs) (Biological)
Placebo (SPIO Solution) Control Group
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.
干预措施: Ferumoxytol (SPIO) Solution for Injection (Placebo) (Other)
结局指标
主要结局
MPI-Based Joint Cavity Retention Rate of SPIO-labeled hUC-MSCs
时间窗: 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.
次要结局
- Change in WOMAC Total Score(Baseline to Week 6 post-injection)
研究者
Tuo Shao
Professor
Soochow University