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Tests treatment safety and results for Knee Osteoarthritis
Official title Efficacy and Safety of IxCell hUC-MSC-O in Patients With Knee Osteoarthritis
ClinicalTrials.gov ID: NCT06716281
What this study is testing
What is Human umbilical cord mesenchymal stem cells?
Human umbilical cord mesenchymal stem cells is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for knee osteoarthritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the efficacy of IxCell hUC-MSC-O in the treatment of patients with knee osteoarthritis. To evaluate the safety of IxCell hUC-MSC-O in the treatment of patients with knee osteoarthritis.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- Patients diagnosed with knee osteoarthritis according to the "Guidelines for the Diagnosis and Treatment of Osteoarthritis (2018 Edition)" by the...
- Patients with persistent pain for more than half a year, or those whose knee osteoarthritis recurs or worsens after discontinuing conventional...
- The study side knee joint Kellgren-Lawrence grade is II～III, and the other side knee Kellgren-Lawrence is ≤II;
- Patients with a total WOMAC score of ≥50 and ≤150 at the time of screening;
- Patients with a VAS pain score of ≥50mm (total score of 100mm) in the study side knee joint at the time of screening;
You likely can't join if
- Patients diagnosed with secondary knee osteoarthritis;
- Patients with other diseases that cause knee joint dysfunction or affect the joint (such as acute joint injuries caused by trauma, rheumatoid...
- Patients with obvious varus or valgus deformities (greater than 15 degrees) in the knee joint or with obvious flexion contractures;
- Patients who have previously used stem cell therapy;
- Patients who have received opioid, non-steroidal anti-inflammatory analgesics, or any other pain-relieving medication for knee osteoarthritis within...
- Patients who have received physiotherapy or traditional Chinese medicine treatment for knee arthritis (either side) within 6 weeks before treatment;
See the full eligibility criteria
Who can join
- Patients diagnosed with knee osteoarthritis according to the "Guidelines for the Diagnosis and Treatment of Osteoarthritis (2018 Edition)" by the Joint Surgery Group of the Orthopedics Branch of the Chinese Medical...
- Patients with persistent pain for more than half a year, or those whose knee osteoarthritis recurs or worsens after discontinuing conventional clinical treatments such as hormones, opioids, non-steroidal...
- The study side knee joint Kellgren-Lawrence grade is II～III, and the other side knee Kellgren-Lawrence is ≤II;
- Patients with a total WOMAC score of ≥50 and ≤150 at the time of screening;
- Patients with a VAS pain score of ≥50mm (total score of 100mm) in the study side knee joint at the time of screening;
- Ages between 40 and 80, with no gender restrictions. BMI (Body Mass Index, weight [kg]/height\^2 [m\^2]) ≤30;
- Able to understand and voluntarily sign the informed consent form, and willing to complete the trial procedures and follow-up examinations.
What rules you out
- Patients diagnosed with secondary knee osteoarthritis;
- Patients with other diseases that cause knee joint dysfunction or affect the joint (such as acute joint injuries caused by trauma, rheumatoid arthritis, metabolic bone disease, psoriatic arthritis, gouty arthritis...
- Patients with obvious varus or valgus deformities (greater than 15 degrees) in the knee joint or with obvious flexion contractures;
- Patients who have previously used stem cell therapy;
- Patients who have received opioid, non-steroidal anti-inflammatory analgesics, or any other pain-relieving medication for knee osteoarthritis within 2 weeks or 7 half-lives (whichever is longer) before treatment;
- Patients who have received physiotherapy or traditional Chinese medicine treatment for knee arthritis (either side) within 6 weeks before treatment;
- Patients who have received local injection of glucocorticoids, anesthetics, or local application of glucocorticoids for the knee joint (either side) within 12 weeks before treatment, or who have received systemic...
- Patients who started taking glucosamine, chondroitin sulfate, or diacerein within 4 weeks before treatment (except those who have been taking glucosamine or chondroitin sulfate for a long time and have continued to take...
- Patients who have received any drug injection treatment in the knee joint cavity (either side) within 6 months before treatment;
- Patients who have undergone major surgery, arthroplasty, or arthroscopy on the study side knee joint within 24 weeks before signing the informed consent form, or those who plan to undergo surgical treatment on the study...
- Patients who have undergone surgical treatment on the lower limbs (hip or knee) within 12 weeks before signing the informed consent form;
- Patients whose study side knee joint is not suitable for MRI examination, such as those with metal implants affected by magnetic fields;
- Patients who plan to undergo any type of lower limb surgery within 48 weeks after signing the informed consent form;
- Patients with skin diseases or skin infections around the intended injection site;
- Patients with osteoarthritis on the opposite side of the study knee joint and who plan to undergo intra-articular drug therapy during the study;
- Patients with hip joint disease on the same side as the study knee joint and who require medical intervention (such as severe hip osteoarthritis);
- Patients with a history of allergic reactions to any components of the trial medication;
- Patients with current malignant tumors or a history of malignant tumors within 5 years before signing the informed consent form;
- Patients with a clear history of mental disorders, or a history of abuse of psychotropic drugs or drug use;
- Patients with severe heart disease (NYHA Class III or above), or liver function abnormalities (serum ALT \> 3×ULN or AST \> 3×ULN), or kidney function abnormalities (serum Cr \> 2×ULN or BUN \> 2×ULN), or coagulation...
- Patients with HBeAg-positive chronic hepatitis B (defined by the 2015 Guidelines for the Prevention and Treatment of Chronic Hepatitis B), or hepatitis C virus infection, or positive for human immunodeficiency virus...
- Female patients who are pregnant or breastfeeding, or male and female patients who refuse to use contraceptive measures (abstinence, physical contraception, or hormonal contraceptives starting 3 months before...
- Patients who have participated in any other clinical trials within 3 months before signing the informed consent form;
- Patients deemed unsuitable for participation in this trial by the investigator for other reasons.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.