Actively Recruiting
Phase I 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 2024-07-01
18
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
W
Wuhan Hamilton Biotechnology Co., Ltd
Collaborating Sponsor
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 I Clinical Trial of UC-MSCs in the Treatment of Knee Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained before any assessment
- Able to communicate well with researchers and follow study requirements
- Age between 50 and 70 years, any gender
- Male weight at least 50 kg, female weight at least 45 kg, BMI between 18 and 26 kg/m2
- Diagnosed with knee osteoarthritis with disease duration over 4 weeks
- Target knee X-ray Kellgren Lawrence grade II-III
- MRI shows partial or full layer cartilage damage in the knee
- VAS pain score between 5 and 7 at least 48 hours after stopping all painkillers during screening
- Willing to stop paracetamol/acetaminophen 2 weeks before treatment and only use NSAIDs as rescue medication
- Willing to stop glucosamine, chondroitin, opioid drugs, or similar at least 2 weeks before treatment
You will not qualify if you...
- History of knee joint infection, surgery, or radiation therapy within 6 months
- Knee joint instability or deformity such as ligament rupture or external deformity
- Other diseases affecting knee function assessment like symptomatic lower back pain or hip joint pain
- Local diseases confusing knee assessment like septic arthritis, reactive arthritis, pseudogout, or joint fractures
- Medication injections or lavage surgery in target knee within 3 months
- Presence of intra-articular or periarticular tumors
- Serious systemic diseases including neurological, respiratory, heart (NYHA III+), liver, kidney, coagulation, or severe blood disorders
- Diagnosed systemic inflammatory arthritis or connective tissue diseases
- Long-term oral corticosteroid use >14 days or need for glucocorticoids during the trial
- Previous stem cell therapy
- Uncontrolled hypertension (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 prohibited drug abuse
- Hypersensitivity to protein drugs
- Contraindications or unwillingness for MRI
- Positive tests for hepatitis B, hepatitis C, AIDS, or syphilis
- Pregnant or breastfeeding women, positive pregnancy test, or planning childbirth within 3 months
- Recent live vaccine use within 1 month
- Participation in other clinical trials within 3 months
- Poor compliance, communication difficulties, or inability to complete the trial
- Investigator judgment deeming participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wuhan Union Hospital
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
H
Hongtao Tian, MD
CONTACT
W
Wei Tong, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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