Using stem cells to treat knee osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSC) therapy for patients suffering from knee osteoarthritis. Participants will be randomly assigned to receive either low or high doses of stem cells through intraarticular injection, with follow-up assessments conducted at multiple intervals over a year. The study will assess both safety through various laboratory tests and efficacy using knee function evaluation scales and MRI imaging to monitor cartilage condition. The goal is to establish a treatment regimen for different degrees of cartilage defects associated with osteoarthritis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of Knee Osteoarthritis by Kellgren and Lawrence Grading Scale, classified with Grade 2-3
* Confirm with cartilage injury,articular cartilage part or full-thickness injury, by MR (Magnetic Resonance)
* Age \<70, no serious organ dysfunction
* Over 2 years knee pain or no very effective with conservative treatments
* Knee pain of VAS (visual analog scale score) is 4 or higher
* Normal hepatic and renal function, no history of gout, rheumatoid arthritis, and autoimmune diseases, etc.
* Understand and sign the consent form of this study

Exclusion Criteria:

* Refuse to sign the consent form, or cannot keep follow-up visit
* Age \>70; Age \<70, but with multiple organ failure
* Unstable vital signs (breath, blood pressure, pulse)
* Combined with knee ligament (anterior and the posterior cruciate ligament, medial and lateral collateral ligament) rupture, laxity, etc.
* Serious bleeding tendency, poor coagulation function (PTA \<35%)
* Pregnant or breast feeding women, or positive pregnancy test in 7 days before treatment
* Participate other clinical experiments in 3 months
* With progressing malignant tumor
* Combined with shock and critically ill patients
* With mental disease, cannot
* With history of knee joint infection, surgery, and radiotherapy
* With immunosuppressive agents treatment in 6 weeks
* Injection with hormones and sodium hyaluronate in joint in 3 months
* Overweight expressed as body mass index (BMI) \>35
* With skin disease around knee joint
* With Immunodeficiency disease, including long term use immunosuppressive agents patients
* Combined with serious infection
* With some other conditions that doctor propose not to participate

Where it's running

• Xiangya Hospital Central South University
  Changsha, Hunan, China Recruiting

Study contacts

• Principal investigator: Hongbin Lu — Xiangya Hospital of Central South University
• Study coordinator: Lei Guo
• Email: georgeguo@sclnow.com
• Phone: 861064368977

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.