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A Single-Center Prospective Randomized Controlled Study on Arthroscopic Debridement Combined with Umbilical Cord Mesenchymal Stem Cell Injection for Knee Osteoarthritis

A Single-Center Prospective Randomized Controlled Study on Arthroscopic Debridement Combined with Umbilical Cord Mesenchymal Stem Cell Injection for Knee Osteoarthritis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109604
Enrollment
Unknown
Registered
2025-09-23
Start date
2025-11-30
Completion date
Unknown
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Interventions

Experimental Group:Knee arthroscopic cleaning Umbilical cord stromal stem cell single injection (5?10^6-1?10^7 UC-MSC/time, GMP preparation of the basic laboratory of the General Hospital of the Centr
Control Group 1:Arthroscopic debridement+Intraoperative Sodium hyaluronate injection (3 mL, 30 mg
Shanghai Haohai).
Control Group 2:Arthroscopic debridement+Intraoperative PRP injection (3 mL, standardized preparation by the hospital blood bank)

Sponsors

General Hospital of Central Theatre Command
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. According to the diagnostic criteria, the diagnosis of knee osteoarthritis was confirmed, and the Kellgren-Lawrence grade was grade II/III; 2. The age of the subject >=50 years old and <=75 years old when signing the informed consent form, and the gender is not limited; 3. The subject's WOMAC score is 24-72 points (defined as: WOMAC score at least 48 hours after stopping the use of all painkillers); 4. In patients with bilateral osteoarthritis, the Kellgren-Lawrence grade of the non-treated side joint should not be higher than grade III; 5. Subjects are in good physical condition and able to walk independently, except for those who use wheelchairs, walkers or crutches.

Exclusion criteria

Exclusion criteria: 1. Received systemic and/or local autologous and/or allogeneic mesenchymal progenitor (stem) cell therapy; 2. Diseases or symptoms that may affect VAS, WOMAC, etc.; 3. Within 3 months prior to surgery, have a severe systemic infection (sepsis or sepsis) or have a local infection in either knee joint (intra-articular infection; 4. Lower limb diseases that may interfere with the evaluation of the knee joint, such as fibromyalgia, more obvious low back pain, lumbar intervertebral disc herniation, etc., need to be excluded; 5. Any abnormality in the preoperative examination and examination, according to the doctor's judgment, the operation may endanger the patient's safety and/or affect the judgment of the knee joint evaluation index shall be excluded; 6. Received knee arthroscopic surgery or other open operations related to the knee joint within 6 months before surgery; 7. Within 1 month before treatment, received glucosamine, chondroitin sulfate, and diacerein treatment; 8. Within 1 month before treatment, oral/intravenous use of hormones such as dexamethasone, prednisone, hydrocortisone, etc.; 9. Received live vaccine or live attenuated vaccine within 1 month before treatment; 10. Contraindications to MRI detection, including but not limited to: cardiac pacemaker, defibrillator, cardiac stent, artificial heart valve, metal clip after aneurysm surgery, drug perfusion device implanted in the body, any electronic device implanted in the body (nerve stimulator, bone growth stimulator), intravascular embolization steel ring, filter, ECG record monitor, metal suture, shrapnel or iron sand particles in the body, fixed steel plate and nail after fracture surgery, cochlear implant, middle ear graft, intraocular metal foreign body, etc.; Claustrophobia, critically ill patients, etc., and other conditions in which the subject is not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Western Ontario and McMaster Universities Osteoarthritis Index;

Secondary

MeasureTime frame
Visual Analogue Scale Score;SF-36 Health Survey Score;

Countries

China

Contacts

Public ContactShijun Wei

General Hospital of Central Theatre Command

wsj1974@yeah.net+86 27 5077 2534

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026