Investigator initiated clinical trial of autologous synovial stem cells for meniscus lesions
- Conditions
- meniscus lesions
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Not provided
1) Patient who is unidentified 2) Patients who underwent menisectomy or meniscus repair in the affected knee 3) Patients whose clinical symptoms have been sufficiently improved by conservative treatments in the last 3 months 4) Patients with knee malalignment. 5) Patients with a history of trauma in the knee 6) Patients for whom MRI is not indicated because of claustrophobia and so on 7) Patients who have had any intraarticular injections (local anesthetic agent, corticosteroid agent, hyaluronic acid) or arthrocentesis in these 3 months. 8) Patients with active infection 9) Patients diagnosed or suspected as malignant tumor in these 5 years 10) Patients sensitive to antibiotics (penicillin, streptomycin or amphotericin B) 11) Patients sensitive to animal (bovine) origin materials 12) Patients with poor controlled diabetes 13) Patients with a pacemaker 14) Patients with poor general condition with following complication; -severe cardiovascular disease -severe liver disorder -severe kidney dysfunction -poorly controlled psychiatric disorder -other diseases which sudden deterioration or aggravation is foreseeable during the study period 15) Pregnant women, lactating women and patient who may be pregnant, or patient who desires pregnancy during clinical study 16) Patient who participated in other clinical trials, patient participating in other clinical studies and patient planning to participate in other clinical studies while participating in this clinical study within 12 weeks before the start of transplantation of cellular product 17) Patient for whom doctors decide as not appropriate to participate in the clinical study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ysholm score
- Secondary Outcome Measures
Name Time Method 1) Efficacy Knee Injury and Osteoarthritis Outcome Score (KOOS) Numerical Rating Scale (NRS) Knee X-ray examination, MRI 3D analysis (meniscal thickness, height, width) MRI analysis of meniscal / cartilage degeneration 2) Safety Adverse event and device-related adverse event data, including type, frequency, severity and duration