Actively Recruiting
Phase II Clinical Trial of UC-MSCs in the Treatment of Knee Osteoarthritis
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2026-04-23
100
Participants Needed
3
Research Sites
166 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. At present, most of the treatment methods for KOA have limited efficacy, only relieving pain symptoms and cannot prevent cartilage damage and other tissue damage in the joints. Due to the limitations of adverse events, there is still no optimal treatment plan for KOA. Most studies believe that autologous mesenchymal stem cell transplantation is a new treatment method with good efficacy and good repair effect for mild to moderate cartilage defects. Given that there is currently no optimal treatment plan for KOA, human umbilical cord mesenchymal stem cell injection has potential development value and is of great significance for the treatment of KOA patients.
CONDITIONS
Official Title
Phase II Clinical Trial of UC-MSCs in the Treatment of Knee Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent is obtained before any assessments
- Able to communicate and follow study requirements
- Age between 40 and 70 years, any gender
- Male weight at least 50 kg, female weight at least 45 kg; BMI between 18 and 28 kg/m2
- Diagnosed with knee osteoarthritis according to 2018 guidelines, with symptoms lasting more than 4 weeks
- Kellgren Lawrence X-ray grade II-III of target knee joint
- MRI shows partial or full cartilage damage in the knee joint
- Knee pain VAS score between 4 and 7 at least 48 hours after stopping all painkillers
- Agree to stop using paracetamol/acetaminophen 2 weeks before treatment; NSAIDs allowed as rescue
- Agree to stop glucosamine, chondroitin, opioids, or similar drugs 2 weeks before treatment
You will not qualify if you...
- History of knee infection, surgery, or radiation in the past 6 months
- Knee joint instability or deformities such as ligament rupture or external deformity
- Other conditions affecting knee function assessment, such as lower back pain or hip pain
- Local diseases like septic arthritis, reactive arthritis, or joint fractures that may affect assessment
- Received any knee injection treatment or lavage surgery within 3 months before treatment
- Presence of intra-articular or periarticular tumors
- Serious systemic diseases including neurological, respiratory, heart (NYHA III+), liver, kidney, coagulation, or severe blood disorders
- Diagnosed with systemic inflammatory arthritis or connective tissue diseases like rheumatoid arthritis or lupus
- Long-term use of corticosteroids over 5 mg/day within 3 months or planned during the study
- Previous stem cell therapy
- Uncontrolled high blood pressure (SBP >160 mmHg or DBP >100 mmHg)
- History of tumors, mental illness, severe autoimmune or hematological diseases, or long-term immunosuppressant use
- History of alcohol or drug abuse
- Known allergy to protein drugs
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Guangzhou First People's Hospital
Wuhan, China
Actively Recruiting
2
Wuhan Fourth Hospital
Wuhan, China
Actively Recruiting
3
Wuhan Third Hospital
Wuhan, China
Actively Recruiting
Research Team
H
Hongtao Tian, MD
CONTACT
W
Wei Tong, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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