NCT03383081 The Safety/Efficacy of hUC Mesenchymal Stem Cells（19#iSCLife®-OA） Therapy for Patients With Osteoarthritis
| NCT ID | NCT03383081 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sclnow Biotechnology Co., Ltd. |
| Condition | Osteoarthritis, Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2018-10-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2018-10-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is verify the efficacy and safety of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSC) therapy for patients with Osteoarthritis, and in addition, provide basis for exploring the treatment regimen of UC-MSC therapy in different degree of cartilage defect disease
Eligibility 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
Contact & Investigator
Hongbin Lu
PRINCIPAL INVESTIGATOR
Xiangya Hospital of Central South University
Frequently Asked Questions
Who can join the NCT03383081 clinical trial?
This trial is open to participants of all sexes, up to 70 Years, studying Osteoarthritis, Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03383081 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03383081 currently recruiting?
Yes, NCT03383081 is actively recruiting participants. Contact the research team at georgeguo@sclnow.com for enrollment information.
Where is the NCT03383081 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT03383081 clinical trial?
NCT03383081 is sponsored by Sclnow Biotechnology Co., Ltd.. The principal investigator is Hongbin Lu at Xiangya Hospital of Central South University. The trial plans to enroll 60 participants.