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New treatment option for Knee Osteoarthritis
Official title Phase I Clinical Trial of UC-MSCs in the Treatment of Knee Osteoarthritis
ClinicalTrials.gov ID: NCT06463847
What this study is testing
What is UC-MSCs?
UC-MSCs 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
- In recent years, the incidence rate and disability rate of osteoarthritis have continued to grow, and it has become a common chronic disease of elderly patients, second only to the "three highs", and poses a continuous threat to China's medical and health system and public health system. Knee osteoarthritis is the main type of osteoarthritis, ranking 11th in global disability diseases and 38th in disability adjusted life year loss, causing significant economic burden to patients, families, and society.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 70
You may be able to join if
- Prior to conducting any assessment, written informed consent must be obtained;
- Able to communicate well with researchers during screening, understand and comply with experimental requirements;
- Age range from 50 to 70 years old (including threshold), regardless of gender;
- Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index (BMI) within the range of 18-26 kg/m2 (including critical values);
- According to the diagnostic criteria for knee osteoarthritis in the "Guidelines for the Diagnosis and Treatment of Osteoarthritis (2018 Edition)"...
You likely can't join if
- Individuals with a history of knee joint infection, surgery, and radiation therapy within 6 months prior to administration;
- Combined instability of the knee joint (anterior and posterior cruciate ligaments, medial and lateral collateral ligaments), rupture, relaxation, or...
- According to researchers, diseases that may interfere with knee joint function assessment, such as symptomatic lower back pain, lumbar disc...
- According to the judgment of researchers, local diseases that may confuse knee joint function assessment include but are not limited to septic...
- Within 3 months prior to administration, any medication injection treatment (including intra-articular injection of growth factors, hormones, or...
- Merge intra-articular or periarticular tumors (such as knee synovial chondroma, pigmented nodular synovitis, etc.);
See the full eligibility criteria
Who can join
- Prior to conducting any assessment, written informed consent must be obtained;
- Able to communicate well with researchers during screening, understand and comply with experimental requirements;
- Age range from 50 to 70 years old (including threshold), regardless of gender;
- Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index (BMI) within the range of 18-26 kg/m2 (including critical values);
- According to the diagnostic criteria for knee osteoarthritis in the "Guidelines for the Diagnosis and Treatment of Osteoarthritis (2018 Edition)", people diagnosed with knee osteoarthritis (see Annex 1 for details); The...
- The target knee joint X-ray Kellgren Lawrence radiological grading (K-L IV grade) is II-III grade. Patients diagnosed with knee osteoarthritis on both sides should have non target knee joint symptoms, signs, and grading...
- MRI examination shows partial or full layer damage to the cartilage of the knee joint;
- A VAS score of ≥ 5 and ≤ 7 for knee joint pain at least 48 hours after discontinuing the use of all painkillers during screening;
- Patients who use analgesic therapy (taking paracetamol/acetaminophen) to control local pain in the target knee joint agree to discontinue the use of similar analgesics 2 weeks prior to administration, and only allow...
What rules you out
- Individuals with a history of knee joint infection, surgery, and radiation therapy within 6 months prior to administration;
- Combined instability of the knee joint (anterior and posterior cruciate ligaments, medial and lateral collateral ligaments), rupture, relaxation, or external deformity of the knee joint;
- According to researchers, diseases that may interfere with knee joint function assessment, such as symptomatic lower back pain, lumbar disc herniation, and hip joint pain in the target knee joint;
- According to the judgment of researchers, local diseases that may confuse knee joint function assessment include but are not limited to septic arthritis, reactive arthritis, clinically recurrent pseudogout...
- Within 3 months prior to administration, any medication injection treatment (including intra-articular injection of growth factors, hormones, or sodium hyaluronate) or lavage surgery has been received in the knee joint...
- Merge intra-articular or periarticular tumors (such as knee synovial chondroma, pigmented nodular synovitis, etc.);
- Various serious systemic diseases such as neurological disorders, respiratory disorders, heart diseases (NYHA grade III and above), and liver dysfunction (ALT\>3) × ULN or AST\>3 × ULN, renal dysfunction (Cr\>2) × ULN...
- Diagnosed as systemic inflammatory arthritis or connective tissue disease, including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout, Paget's disease, systemic lupus...
- people who receive long-term (\>14 days) oral corticosteroids\>5 mg/day within 3 months prior to administration, or who require long-term glucocorticoid treatment during the trial period;
- Previously received stem cell therapy;
- Uncontrolled hypertension is defined as systolic blood pressure (SBP)\>160 mmHg or diastolic blood pressure (DBP)\>100 mmHg during screening;
- Having a history of tumors, mental illness, severe autoimmune diseases, hematological diseases, and long-term use of immunosuppressants;
- Have a history of alcohol and prohibited drug abuse;
- Has a history of hypersensitivity to protein drugs;
- There are contraindications to MRI examination or unwillingness to undergo MRI examination;
- Hepatitis B, hepatitis C, AIDS, syphilis serological test positive pathogens;
- Pregnant or lactating women, or male or female patients who tested positive for blood pregnancy during screening or have planned childbirth within 3 months after medication;
- Patients who have received live vaccines or attenuated live vaccines within one month before administration;
- Patients who have participated in clinical trials of other drugs or devices within 3 months prior to administration;
- Patients with poor compliance, poor communication skills, inability to adhere to follow-up, and inability to complete the entire trial;
- The researchers believe that it is not suitable for participants to enter this experiment.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, 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, 50 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, 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.