Using stem cells to treat knee osteoarthritis
A Clinical Research on the Safety/Efficacy of Human Umbilical Cord Mesenchymal Stem Cells（19#iSCLife®-OA） Therapy for Patients With Osteoarthritis
This study is testing if injections of stem cells from umbilical cords can help people with knee osteoarthritis feel better and improve their knee function.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | N/A to 70 Years |
| Sex | All |
| Sponsor | Sclnow Biotechnology Co., Ltd. Industry-sponsored |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT03383081 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals under 70 years old with a diagnosis of knee osteoarthritis classified as Grade 2-3 and experiencing significant pain.
Not a fit: Patients over 70 years old or those with serious organ dysfunction or other significant knee injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a novel and effective treatment option for patients with knee osteoarthritis, potentially improving their quality of life.
How similar studies have performed: While the use of mesenchymal stem cells in treating osteoarthritis is a growing field, this specific approach is still being explored and has not been widely tested in similar trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Changsha, Hunan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.