Knee Arthritis OsteoarthritisEarly Phase 1NCT07313020
Handheld MPI Imaging to Track Stem Cells in Osteoarthritis
A Early Phase 1 study testing Human Umbilical Cord-derived Mesenchymal Stromal Cells (hUC-MSCs) in people with Knee Arthritis Osteoarthritis, run by Soochow University at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Knee Arthritis Osteoarthritis
- What is being tested?
- Human Umbilical Cord-derived Mesenchymal Stromal Cells (hUC-MSCs)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 16 Dec 2025to 16 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Visualization Clinical Study Using a Handheld MPI Imaging Device for Monitoring Mesenchymal Stromal Cells in Osteoarthritis 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.
- Conditions
- Knee Arthritis Osteoarthritis
- Being tested
- Human Umbilical Cord-derived Mesenchymal Stromal Cells (hUC-MSCs), Ferumoxytol (SPIO) Solution for Injection (Placebo)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| UC-MSCs + SPIO + MPI Monitoring Group | Experimental | 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. Receives: Biological: Human Umbilical Cord-derived Mesenchymal Stromal Cells (hUC-MSCs) |
| Placebo (SPIO Solution) Control Group | Placebo comparator | 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. Receives: Other: Ferumoxytol (SPIO) Solution for Injection (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-injection) to Day 7 post-injection
Secondary outcomes (1)
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.
Measured: Baseline to Week 6 post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start16 Dec 2025
- Primary completion16 Feb 2026
- Study completion16 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Knee Arthritis OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuo Shao, Soochow University
- Investigators
- Tuo Shao, Study director, Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313020
- Sponsor's protocol ID
- KXXSC2025-IIT-23
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 12 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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).
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.
PubMed 38435827Ferreira-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.
PubMed 38675647Nejadnik 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.
PubMed 30734542Matas 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.
PubMed 38366909Pico 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 2024 Oct 16.
PubMed 39503681Negoro 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.
PubMed 30345076Xiang 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.
PubMed 35012666Vina ER, Kwoh CK. Epidemiology of osteoarthritis: literature update. Curr Opin Rheumatol. 2018 Mar;30(2):160-167. doi: 10.1097/BOR.0000000000000479.
PubMed 29227353Scheuing WJ, Reginato AM, Deeb M, Acer Kasman S. The burden of osteoarthritis: Is it a rising problem? Best Pract Res Clin Rheumatol. 2023 Jun;37(2):101836. doi: 10.1016/j.berh.2023.101836. Epub 2023 Aug 24.
PubMed 37633827Allen KD, Thoma LM, Golightly YM. Epidemiology of osteoarthritis. Osteoarthritis Cartilage. 2022 Feb;30(2):184-195. doi: 10.1016/j.joca.2021.04.020. Epub 2021 Sep 14.
PubMed 34534661
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Visualization Clinical Study Using a Handheld MPI Imaging Device for Monitoring Mesenchymal Stromal Cells in Osteoarthritis Treatment
- ClinicalTrials.gov ID
- NCT07313020
- Acronym / sponsor ID
- KXXSC2025-IIT-23
- Conditions
- Knee Arthritis Osteoarthritis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Soochow UniversityUniversity, hospital or other
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 16 Feb 2026 (actual)
- Study completion
- 16 Dec 2026 (estimated)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UC-MSCs + SPIO + MPI Monitoring Group | Experimental | Biological: Human Umbilical Cord-derived Mesenchymal Stromal Cells (hUC-MSCs)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. |
| Placebo (SPIO Solution) Control Group | Placebo comparator | Other: Ferumoxytol (SPIO) Solution for Injection (Placebo)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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 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. | Biological | UC-MSCs + SPIO + MPI Monitoring Group |
| 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. | Other | Placebo (SPIO Solution) Control Group |
Primary outcome
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.
1 secondary outcome
Change in WOMAC Total Score
Time frame: Baseline to Week 6 post-injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Background: PubMed 38435827Feng 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.
- Background: PubMed 38675647Ferreira-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.
- Background: PubMed 30734542Nejadnik 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.
- Background: PubMed 38366909Matas 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.
- Background: PubMed 39503681Pico 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 2024 Oct 16.
- Background: PubMed 30345076Negoro 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.
- Background: PubMed 35012666Xiang 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.
- Background: PubMed 29227353Vina ER, Kwoh CK. Epidemiology of osteoarthritis: literature update. Curr Opin Rheumatol. 2018 Mar;30(2):160-167. doi: 10.1097/BOR.0000000000000479.
- Background: PubMed 37633827Scheuing WJ, Reginato AM, Deeb M, Acer Kasman S. The burden of osteoarthritis: Is it a rising problem? Best Pract Res Clin Rheumatol. 2023 Jun;37(2):101836. doi: 10.1016/j.berh.2023.101836. Epub 2023 Aug 24.
- Background: PubMed 34534661Allen KD, Thoma LM, Golightly YM. Epidemiology of osteoarthritis. Osteoarthritis Cartilage. 2022 Feb;30(2):184-195. doi: 10.1016/j.joca.2021.04.020. Epub 2021 Sep 14.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tuo Shao study director
Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Human Umbilical Cord-derived Mesenchymal Stromal Cells (hUC-MSCs) in people with Knee Arthritis Osteoarthritis, run by Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MPI-Based Joint Cavity Retention Rate of SPIO-labeled hUC-MSCs (time frame: Baseline (pre-injection) to Day 7 post-injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07313020, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.